General Principles2
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2.能源综合⽣产能⼒(亿吨标准煤)Overall energy production capacity (100 million tons of standard coal)(⼆)科技前沿领域攻关Tackling key problems in frontier science and technology1. 新⼀代⼈⼯智能New generation of artificial intelligence前沿基础理论突破,专⽤芯⽚研发,深度学习框架等开源算法平台构建,学习推理和决策、图像图形、语⾳视频、⾃然语⾔识别处理等领域创新。
Make breakthroughs in advanced basic theories, research and develop dedicated chips, build platforms for open-source algorithms such as deep learning framework, innovate in learning reasoning and decision-making, images and graphics, voice and video, natural language recognition and processing, and other fields.2. 量⼦信息Quantum information城域、城际、⾃由空间量⼦通信技术研发,通⽤量⼦计算原型机和实⽤化量⼦模拟机研制,量⼦精密测量技术突破。
Research and develop metropolitan, intercity, and free space quantum communication technology, research and produce general quantum computer prototypes and practical quantum simulators and make breakthroughs in quantum precision measurement technology.3. 集成电路Integrated circuits集成电路设计⼯具、重点装备和⾼纯靶材等关键材料研发,集成电路先进⼯艺和绝缘栅双极型晶体管(IGBT)、微机电系统(MEMS)等特⾊⼯艺突破,先进存储技术升级,碳化硅、氮化镓等宽禁带半导体发展。
(完整版)罗宾斯《管理学》内容概要,中英文对照罗宾斯《管理学》内容概要第一篇导论1章管理者和管理1、组织组织(organization)的定义:对完成特定使命的人们的系统性安排组织的层次:操作者(operatives)和管理者(基层、中层、高层)2、管理者和管理管理者(managers)的定义:指挥别人活动的人管理(management)的定义:同别人一起或者通过别人使活动完成得更有效的过程。
管理追求效率(efficiency)和效果(effectiveness)管理职能(management functions):计划(planning)、组织(organizing)、领导(leading)、控制(controlling)管理者角色(management roles):人际关系角色(interpersonal roles)、信息角色(information roles)、决策角色(decision roles) 成功的管理者和有效的管理者并不等同,在活动时间上,有效的管理者花费了大量的时间用于沟通,而网络联系(社交等)占据了成功的管理者很大部分时间。
管理者在不同的组织中进行着不同的工作。
组织的国别、组织的类型、组织的规模以及管理者在组织中的不同层次决定了管理者的角色扮演、工作内容以及职能和作用。
2章管理的演进1、20世纪以前的管理:亚当·斯密的劳动分工理论(division of labor)产业革命(industrial revolution)2、多样化时期(20世纪):科学管理(scientific management):弗雷德里克·泰勒一般行政管理理论(general administrative theory):亨利·法约尔(principles of management)、马克斯·韦伯(bureaucracy) 人力资源方法(human resources approach):权威的接受观点(acceptance view of authority),霍桑研究,人际关系运动(卡内基、马斯洛),行为科学理论家(behavioral science theorists) 定量方法(quantitative approach)3、近年来的趋势(20世纪后期):趋向一体化过程方法(process approach)系统方法(systems approach):封闭系统和开放系统(closed systems)权变方法(contingency approach):一般性的权变变量包括组织规模、任务技术的例常性、环境的不确定性、个人差异4、当前的趋势和问题(21世纪):变化中的管理实践全球化(globalization)工作人员多样化(work force diversity)道德(morality)激励创新(innovations)和变革(changes)全面质量管理(total quality management, TQM):由顾客需要和期望驱动的管理哲学授权(delegation)工作人员的两极化(bi-modal work force)3章组织文化与环境:管理的约束力量1、组织组织文化(organizational culture)被用来指共有的价值体系。
OFFSHORE STANDARDD ET N ORSKE VERITASDNV-OS-C201STRUCTURAL DESIGN OF OFFSHOREUNITS (WSD METHOD)APRIL 2005Since issued in print (April 2005), this booklet has been amended, latest in April 2006.See the reference to “Amendments and Corrections” on the next page.Comments may be sent by e-mail to rules@For subscription orders or information about subscription terms, please use distribution@Comprehensive information about DNV services, research and publications can be found at http :// , or can be obtained from DNV,Veritasveien 1, NO-1322 Høvik, Norway; Tel +47 67 57 99 00, Fax +47 67 57 99 11.© Det Norske Veritas. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, including photocopying and recording, without the prior written consent of Det Norske puter Typesetting (FM+SGML) by Det Norske Veritas.Printed in Norway.If any person suffers loss or damage which is proved to have been caused by any negligent act or omission of Det Norske Veritas, then Det Norske Veritas shall pay compensation to such person for his proved direct loss or damage. However, the compensation shall not exceed an amount equal to ten times the fee charged for the service in question, provided that the maximum compen-sation shall never exceed USD 2 million.In this provision "Det Norske Veritas" shall mean the Foundation Det Norske Veritas as well as all its subsidiaries, directors, officers, employees, agents and any other acting on behalf of Det Norske Veritas.FOREWORDDET NORSKE VERITAS (DNV) is an autonomous and independent foundation with the objectives of safeguarding life, prop-erty and the environment, at sea and onshore. DNV undertakes classification, certification, and other verification and consultancy services relating to quality of ships, offshore units and installations, and onshore industries worldwide, and carries out research in relation to these functions.DNV Offshore Codes consist of a three level hierarchy of documents:—Offshore Service Specifications. Provide principles and procedures of DNV classification, certification, verification and con-sultancy services.—Offshore Standards. Provide technical provisions and acceptance criteria for general use by the offshore industry as well asthe technical basis for DNV offshore services.—Recommended Practices. Provide proven technology and sound engineering practice as well as guidance for the higher levelOffshore Service Specifications and Offshore Standards.DNV Offshore Codes are offered within the following areas:A)Qualification, Quality and Safety Methodology B)Materials Technology C)Structures D)SystemsE)Special Facilities F)Pipelines and Risers G)Asset Operation H)Marine Operations J)Wind TurbinesAmendments and CorrectionsThis document is valid until superseded by a new revision. Minor amendments and corrections will be published in a separate document normally updated twice per year (April and October).For a complete listing of the changes, see the “Amendments and Corrections” document located at: /technologyservices/, “Offshore Rules & Standards”, “Viewing Area”.The electronic web-versions of the DNV Offshore Codes will be regularly updated to include these amendments and corrections.Amended April 2006,Offshore Standard DNV-OS-C201, April 2005 see note on front cover Changes – Page 3Changes April 2005—Sec.1. Unification of requirements, level of references, terms, definitions, lay-out, text, etc. with the LRFD stand-ards, i.e. general standard (DNV-OS-C101), the standards for various objects (DNV-OS-C102 to DNV-OS-C106), as well as the fabrication standard (DNV-OS-C401). —Sec.1 & Sec.2. Definition and application of design tem-perature and service temperature has been updated, and the terminology co-ordinated with the LRFD standards.—Sec.4. Overall conditions for fracture mechanics (FM) testing, and post weld heat treatment (PWHT) transferred here (from DNV-OS-C401). Requirements to FM adjusted to reflect results of more recent research work. —Sec.5. References to the more recent Recommended Prac-tices introduced e.g. DNV-RP-C201 (for Plates), updating references to CN 30.1.—Sec.3 D300. Specified tank pressures are harmonised with similar formulas in the LRFD standards, while simultane-ously attempted simplified and clarified.—Sec.11 to Sec.14. (Ref. to the various objects.) Formulas for sea pressure during transit are reorganised and clari-fied, improving readability.—Sec.12. Text covering redundancy and detailed design re-vised in line with DNV-OS-C104 (and the previous MOU-rules).—Sec.13. Text regarding the topics of tendon fracture me-chanics, composite tendons, and stability, as well as the CMC requirements are all updated, bringing the text in line with most recent revision of DNV-OS-C105.—Sec.14. Text updated in line with ongoing revision of DNV-OS-C106.D ET N ORSKE V ERITASOffshore Standard DNV-OS-C201, April 2005Amended April 2006, Page 4 – Changes see note on front coverD ET N ORSKE V ERITASAmended April 2006,Offshore Standard DNV-OS-C201, April 2005 see note on front cover Contents – Page 5CONTENTSSec. 1Introduction (9)A.General (9)A100Introduction (9)A200Objectives (9)A300Scope and application (9)A400Other than DNV codes (9)A500Classification (9)B.References (9)B100General (9)C.Definitions (10)C100Verbal forms (10)C200Terms (10)D.Abbreviations and Symbols (12)D100Abbreviations (12)D200Symbols (12)Sec. 2Design Principles (15)A.Introduction (15)A100General (15)A200Aim of the design (15)B.General Design Considerations (15)B100General (15)B200Overall design (15)B300Details design (15)C.Design Conditions (15)C100Basic conditions (15)D.Loading Conditions (16)D100General (16)D200Load (16)E.Design by the WSD Method (16)E100Permissible stress and usage factors (16)E200Basic usage factors (16)F.Design Assisted by Testing (16)F100General (16)F200Full-scale testing and observation of performance of existing structures (16)Sec. 3Loads and Load Effects (17)A.Introduction (17)A100General (17)B.Basis for Selection of Loads (17)B100General (17)C.Permanent Functional Loads (17)C100General (17)D.Variable Functional Loads (18)D100General (18)D200Variable functional loads on deck areas (18)D300Tank pressures (18)D400Lifeboat platforms (19)E.Environmental Loads (19)E100General (19)E200Environmental conditions for mobile units (19)E300Environmental conditionss for site specific units (19)E400Determination of hydrodynamic loads (19)E500Wave loads (19)E600Wave induced inertia forces (20)E700Current (20)E800Wind loads (20)E900Vortex induced oscillations (20)E1000Water level and tidal effects (20)E1100Marine growth (20)E1200Snow and ice accumulation............................................20E1300Direct ice load.. (20)E1400Earthquake (20)bination of Environmental Loads (21)F100General (21)G.Accidental Loads (21)G100General (21)H.Deformation Loads (21)H100General (21)H200Temperature loads (21)H300Settlements and subsidence of sea bed (21)I.Fatigue loads (22)I100General (22)J.Load Effect Analysis (22)J100General (22)J200Global motion analysis (22)J300Load effects in structures and soil or foundation (22)Sec. 4Structural Categorisation, Material Selection and Inspection Principles (23)A.General (23)A100 (23)B.Temperatures for Selection of Material (23)B100General (23)B200Floating units (23)B300Bottom fixed units (23)C.Structural Category (23)C100General (23)C200Selection of structural category (23)C300Inspection of welds (24)D.Structural Steel (24)D100General (24)D200Material designations (24)D300Selection of structural steel (25)D400Fracture mechanics (FM) testing (25)D500Post weld heat treatment (PWHT) (25)Sec. 5Structural Strength (26)A.General (26)A100General (26)A200Structural analysis (26)A300Ductility (26)A400Yield check (26)A500Buckling check (27)B.Flat Plated Structures and Stiffened Panels (27)B100Yield check (27)B200Buckling check (27)B300Capacity checks according to other codes (27)C.Shell Structures (27)C100General (27)D.Tubular Members, Tubular Joints and Conical Transitions.27 D100General (27)E.Non-Tubular Beams, Columns and Frames (28)E100General (28)Sec. 6Section Scantlings (29)A.General (29)A100Scope (29)B.Strength of Plating and Stiffeners (29)B100Scope (29)B200Minimum thickness (29)B300Bending of plating (29)D ET N ORSKE V ERITASOffshore Standard DNV-OS-C201, April 2005Amended April 2006, Page 6 – Contents see note on front coverB400Stiffeners (29)C.Bending and Shear in Girders (30)C100General (30)C200Minimum thickness (30)C300Bending and shear (30)C400Effective flange (30)C500Effective web (30)C600Strength requirements for simple girders (30)C700Complex girder systems (31)Sec. 7Fatigue (32)A.General (32)A100General (32)A200Design fatigue factors (32)A300Methods for fatigue analysis (32)A400Simplified fatigue analysis (33)A500Stochastic fatigue analysis (33)Sec. 8Accidental Conditions (34)A.General (34)A100General (34)B.Design Criteria (34)B100General (34)B200Collision (34)B300Dropped objects (34)B400Fires (34)B500Explosions (34)B600Unintended flooding (34)Sec. 9Weld Connections (36)A.General (36)A100Scope (36)B.Types of Welded Steel Joints (36)B100Butt joints (36)B200Tee or cross joints (36)B300Slot welds (37)B400Lap joint (37)C.Weld Size (37)C100General (37)C200Fillet welds (37)C300Partly penetration welds and fillet welds in crossconnections subject to high stresses (38)C400Connections of stiffeners to girders and bulkheads, etc..38 C500End connections of girders (39)C600Direct calculation of weld connections (39)Sec. 10Corrosion Control (40)A.General (40)A100Scope (40)B.Techniques for Corrosion Control Related to EnvironmentalZones (40)B100Atmospheric zone (40)B200Splash zone (40)B300Submerged zone (40)B400Internal zone (40)C.Cathodic Protection (41)C100General (41)C200Galvanic anode systems (41)C300Impressed current systems (42)D.Coating Systems (42)D100Specification of coating (42)Sec. 11Special Considerations for Column Stabilised Units (43)A.General (43)A100Assumptions and application (43)B.Structural Categorisation, Material Selection and InspectionPrinciples (43)B100General (43)B200Structural categorisation (43)B300Material selection (43)B400Inspection categories (44)C.Design and Loading Conditions (46)C100General (46)C200Permanent loads (46)C300Variable functional loads (46)C400Tank loads (46)C500Environmental loads, general (46)C600Sea pressures (47)C700Wind loads (47)C800Heavy components (47)C900Combination of loads (47)D.Structural Strength (47)D100General (47)D200Global capacity (47)D300Transit condition (47)D400Method of analysis (48)D500Air gap (48)E.Fatigue (48)E100General (48)E200Fatigue analysis (49)F.Accidental Conditions (49)F100General (49)F200Collision (49)F300Dropped objects (49)F400Fire (49)F500Explosion (49)F600Heeled condition (49)G.Redundancy (49)G100General (49)G200Brace arrangements (49)H.Structure in Way of a Fixed Mooring System (49)H100Structural strength (49)I.Structural Details (50)I100General (50)Sec. 12Special Considerations forSelf-Elevating Units (51)A.Introduction (51)A100Scope and application (51)B.Structural Categorisation, Material Selection and InspectionPrinciples (51)B100General (51)B200Structural categorisation (51)B300Material selection (51)B400Inspection categories (51)C.Design and Loading Conditions (51)C100General (51)C200Transit (52)C300Installation and retrieval (52)C400Operation and survival (52)D.Environmental Conditions (53)D100General (53)D200Wind (53)D300Waves (53)D400Current (53)D500Snow and ice (53)E.Method of Analysis (53)E100General (53)E200Global structural models (54)E300Local structural models (54)E400Fatigue analysis (55)F.Design Loads (55)F100General (55)F200Permanent loads (55)D ET N ORSKE V ERITASAmended April 2006,Offshore Standard DNV-OS-C201, April 2005 see note on front cover Contents – Page 7F300Variable functional loads (55)F400Tank loads (55)F500Environmental loads, general (55)F600Wind loads (55)F700Waves (56)F800Current (56)F900Wave and current (56)F1000Sea pressures during transit (57)F1100Heavy components during transit (57)F1200Combination of loads (57)G.Structural Strength (57)G100General (57)G200Global capacity (57)G300Footing strength (57)G400Leg strength (58)G500Jackhouse support strength (58)G600Hull strength (58)H.Fatigue Strength (58)H100General (58)H200Fatigue analysis (58)I.Accidental Conditions (58)I100General (58)I200Collisions (58)I300Dropped objects (58)I400Fires (58)I500Explosions (58)I600Unintended flooding (58)J.Miscellaneous requirements (59)J100General (59)J200Pre-load capasity (59)J300Overturning stability (59)J400Air gap (59)Sec. 13Special Considerations forTension Leg Platforms (TLP) (61)A.General (61)A100Scope and application (61)A200Description of tendon system (61)B.Structural Categorisation, Material Selection and InspectionPrinciples (62)B100General (62)B200Structural categorisation (62)B300Material selection (63)B400Design temperatures (63)B500Inspection categories (63)C.Design Principles (63)C100General (63)C200Design conditions (64)C300Fabrication (64)C400Hull and Deck Mating (64)C500Sea transportation (64)C600Installation (64)C700Decommissioning (64)C800Design principles, tendons (64)D.Design Loads (65)D100General (65)D200Load categories (65)E.Global Performance (65)E100General (65)E200Frequency domain analysis (66)E300High frequency analyses (66)E400Wave frequency analyses (66)E500Low frequency analyses (66)E600Time domain analyses (66)E700Model testing (67)E800Load effects in the tendons (67)F.Structural Strength (67)F100General (67)F200Hull (68)F300Structural analysis (68)F400Structural design.............................................................68F500Deck.. (68)F600Extreme tendon tensions (69)F700Structural design of tendons (69)F800Foundations (69)G.Fatigue (69)G100General (69)G200Hull and deck (69)G300Tendons (69)G400Foundation (70)H.Accidental Condition (70)H100Hull (70)H200Hull and deck (71)H300Tendons (71)H400Foundations (71)Sec. 14Special Considerations for Deep DraughtFloaters (DDF) (72)A.General (72)A100Introduction (72)A200Scope and application (72)B.Non-Operational Phases (72)B100General (72)B200Fabrication (72)B300Mating (72)B400Sea transportation (72)B500Installation (72)B600Decommissioning (73)C.Structural Categorisation, Selection of Material andExtent of Inspection (73)C100General (73)C200Material selection (73)C300Design temperatures (73)C400Inspection categories (73)C500Guidance to minimum requirements (73)D.Design Loads (74)D100Permanent loads (74)D200Variable functional loads (74)D300Environmental loads (74)D400Determination of loads (74)D500Hydrodynamic loads (74)E.Deformation Loads (74)E100General (74)F.Accidental Loads (75)F100General (75)G.Fatigue Loads (75)G100General (75)bination of Loads (75)H100General (75)I.Load Effect Analysis in Operational Phase (75)I100General (75)I200Global bending effects (75)J.Load Effect Analysis in Non-Operational Phases (75)J100General (75)J200Transportation (76)J300Launching (76)J400Upending (76)J500Deck mating (76)J600Riser installations (76)K.Structural Strength (76)K100Operation phase for hull (76)K200Non-operational phases for hull (76)K300Operation phase for deck or topside (77)K400Non-operational phases for deck or topside (77)L.Fatigue (77)L100General (77)L200Operation phase for hull (77)L300Non-operational phases for hull (77)D ET N ORSKE V ERITASOffshore Standard DNV-OS-C201, April 2005Amended April 2006, Page 8 – Contents see note on front coverL400Splash zone (77)L500Operation phase for deck or topside (78)L600Non-operational phases for deck or topside (78)M.Accidental Condition (78)M100General (78)M200Fire (78)M300Explosion (78)M400Collision (78)M500Dropped objects (78)M600Unintended flooding (78)M700Abnormal wave events (78)App. A Cross Sectional Types (80)A.Cross Sectional Types (80)A100General (80)A200Cross section requirements for plastic analysis (80)A300Cross section requirements whenelastic global analysis is used (80)App. B Methods and Models for Design of Column-Stabilised Units (82)A.Methods and Models (82)A100General (82)A200World wide operation (82)A300Benign waters or restricted areas (82)App. C Permanently Installed Units (83)A.Introduction (83)A100Application (83)B.Inspection and Maintenance (83)B100Facilities for inspection on location................................83C.Fatigue. (83)C100Design fatigue factors (83)C200Splash zone for floating units (83)App. D Certification of Tendon System (84)A.General (84)A100Introduction (84)B.Equipment categorization (84)B100General (84)C.Fabrication Record (84)C100General (84)D.Documentation Deliverables for Certification ofEquipment (85)D100General (85)E.Tendon Systems and Components (85)E100General (85)E200Tendon pipe (85)E300Bottom tendon interface (BTI) (86)E400Flex bearings (86)E500Foundations (86)E600Top tendon interface (TTI) (86)E700Intermediate tendon connectors (ITC) (86)E800Tendon tension monitoring system (TTMS) (86)E900Tendon porch (87)E1000Tendon corrosion protection system (87)E1100Load management program (LMP) (87)F.Categorisation of Tendon Components (87)F100General (87)G.Tendon Fabrication (88)G100General (88)D ET N ORSKE V ERITASAmended April 2006,Offshore Standard DNV-OS-C201, April 2005 see note on front cover Sec.1 – Page 9SECTION 1INTRODUCTIONA. GeneralA 100Introduction101 This offshore standard provides principles, technical re-quirements and guidance for the structural design of offshore structures, based on the Working Stress Design (WSD) meth-od.102 This standard has been written for general world-wide application. Statutory regulations may include requirements in excess of the provisions by this standard depending on size, type, location and intended service of the offshore unit or in-stallation.103 The standard is organised with general sections contain-ing common requirements and sections containing specific re-quirement for different type of offshore units. In case of deviating requirements between general sections and the ob-ject specific sections, requirements of the object specific sec-tions shall apply.A 200Objectives201 The objectives of this standard are to:—provide an internationally acceptable level of safety by de-fining minimum requirements for structures and structural components (in combination with referred standards, rec-ommended practices, guidelines, etc.)—serve as a contractual reference document between suppli-ers and purchasers—serve as a guideline for designers, suppliers, purchasers and regulators—specify procedures and requirements for offshore struc-tures subject to DNV certification and classification.A 300Scope and application301 This standard is applicable to the following types of off-shore structures:—column-stabilised units—self-elevating units—tension leg platforms—deep draught floaters.302 For utilisation of other materials, the general design principles given in this standard may be used together with rel-evant standards, codes or specifications covering the require-ments to materials design and fabrication.303 The standard is applicable to structural design of com-plete units including substructures, topside structures and ves-sel hulls.304 This standard gives requirements for the following: —design principles—structural categorisation—material selection and inspection principles—loads and load effect analyses—design of steel structures and connections—special considerations for different types of units. Requirements for foundation design are given in DNV-OS-C101.A 400Other than DNV codes401 Other recognised codes or standards may be applied pro-vided it is shown that the codes and standards, and their appli-cation, meet or exceed the level of safety of the actual DNV standard.402 In case of conflict between requirements of this standard and a reference document other than DNV documents, the re-quirements of this standard shall prevail.403 Where reference is made to codes other than DNV doc-uments, the latest revision of the documents shall be applied, unless otherwise specified.404 When code checks are performed according to other than DNV codes, the usage factors as given in the respective code shall be used.A 500Classification501 Classification principles, procedures and applicable class notations related to classification services of offshore units are specified in the DNV Offshore Service Specifications given in Table A1.502 Documentation requirements for classification are given by DNV-RP-A202.B. ReferencesB 100General101 The DNV documents in Table B1 are referred to in the present standards and contain acceptable methods for fulfilling the requirements in this standard.102 The latest valid revision of the DNV reference docu-ments in Table B2 applies. See also current DNV List of Pub-lications.103 The documents listed in Table B2 are referred in the present standard. The documents include acceptable methods for fulfilling the requirements in the present standard and may be used as a source of supplementary information. Only the referenced parts of the documents apply for fulfilment of the present standard.Table A1 DNV Offshore Service SpecificationsReference TitleDNV-OSS-101Rules for Classification of Offshore Drilling andSupport UnitsDNV-OSS-102Rules for Classification of Floating Productionand Storage UnitsDNV-OSS-103Rules for Classification of LNG/LPG FloatingProduction and Storage Units or Installations DNV-OSS-121Classification Based on Performance CriteriaDetermined by Risk Assessment MethodologyRules for Planning and Execution of MarineOperationsTable B1 DNV Reference DocumentsReference TitleDNV-OS-A101Safety Principles andArrangementDNV-OS-B101Metallic MaterialsDNV-OS-C101Design of Offshore Steel Struc-tures, General (LRFD method) DNV-OS-C301Stability and Watertight Integrity DNV-OS-C401Fabrication and Testing ofOffshore StructuresD ET N ORSKE V ERITASOffshore Standard DNV-OS-C201, April 2005Amended April 2006, Page 10 – Sec.1see note on front coverC. DefinitionsC 100Verbal forms101 Shall: Indicates a mandatory requirement to be followed for fulfilment or compliance with the present standard. Devia-tions are not permitted unless formally and rigorously justified, and accepted by all relevant contracting parties.102 Should: Indicates a recommendation that a certain course of action is preferred or particularly suitable. Alterna-tive courses of action are allowable under the standard where agreed between contracting parties but shall be justified and documented.103 May: Indicates a permission, or an option, which is per-mitted as part of conformance with the standard.C 200Terms201 Accidental condition: When the unit is subjected to ac-cidental loads such as collision, dropped objects, fire explo-sion, etc.202 Accidental loads: Loads which may occur as a result of accident or exceptional events, e.g. collisions, explosions, dropped objects.203 Atmospheric zone: The external surfaces of the unit above the splash zone.204 Cathodic protection: A technique to prevent corrosion of a steel surface by making the surface to be the cathode of an electrochemical cell.205 Characteristic load: The reference value of a load to be used in the determination of load effects. The characteristic load is normally based upon a defined fractile in the upper end of the distribution function for load.206 Characteristic strength: The reference value of structur-al strength to be used in the determination of the design strength. The characteristic strength is normally based upon a 5% fractile in the lower end of the distribution function for re-sistance.207 Characteristic value: The representative value associat-ed with a prescribed probability of not being unfavourably ex-ceeded during the applicable reference period.208 Classic spar: Shell type hull structure.209 Classification Note: The Classification Notes cover proven technology and solutions which is found to represent good practice by DNV, and which represent one alternative for satisfying the requirements given in the DNV Rules or other codes and standards cited by DNV. The Classification Notes will in the same manner be applicable for fulfilling the require-ments in the DNV Offshore Standards.210 Coating: Metallic, inorganic or organic material applied to steel surfaces for prevention of corrosion.211 Column-stabilised unit: A floating unit that can be relo-cated. A column-stabilised unit normally consists of a deck structure with a number of widely spaced, large diameter, sup-porting columns that are attached to submerged pontoons. 212 Corrosion allowance: Extra wall thickness added during design to compensate for any anticipated reduction in thick-ness during the operation.213 Damaged condition: The unit condition after accidental damage.214 Deep draught floater (DDF): A floating unit categorised with a relative large draught. The large draught is mainly intro-duced to obtain reduced wave excitation in heave and suffi-ciently high eigenperiod in heave such that resonant responses in heave can be omitted or minimised.215 Design brief: An agreed document presenting owner's technical basis, requirements and references for the unit design and fabrication.216 Design temperature: The design temperature for a unit is the reference temperature for assessing areas where the unit can be transported, installed and operated. The design temper-ature is to be lower or equal to the lowest mean daily tempera-ture in air for the relevant areas. For seasonal restricted operations the lowest mean daily temperature in air for the sea-son may be applied.217 Driving voltage: The difference between closed circuit anode potential and the protection potential.218 Dry transit: A transit where the unit is transported on a heavy lift unit from one geographical location to another. 219 Dynamic upending: A process where seawater is filled or flooded into the bottom section of a horizontally floating DDF hull and creating a trim condition and subsequent water filling of hull or moonpool and dynamic upending to bring the hull in vertical position.220 Environmental loads: Loads directly and indirectly due to environmental phenomena. Environmental loads are not a necessary consequence of the structures existence, use and treatments. All external loads which are responses to environ-mental phenomena are to be regarded as environmental loads, e.g. support reactions, mooring forces, and inertia forces. 221 Expected loads and response history: Expected load and response history for a specified time period, taking into ac-count the number of load cycles and the resulting load levels and response for each cycle.222 Expected value: The most probable value of a load dur-ing a specified time period.223 Fail to safe: A failure shall not lead to new failure, which may lead to total loss of the structure.DNV-OS-D101Marine Machinery Systems andEquipmentDNV-OS-E301Position MooringDNV-OS-F201Dynamic RisersDNV-RP-C103Column Stabilised UnitsDNV-RP-C201Buckling Strength of PlatedStructuresDNV-RP-C202Buckling Strength of Shells DNV-RP-C203Fatigue Strength Analysis ofOffshore Steel Structures Classification Note 30.1Buckling Strength Analysis ofBars and Frames, and SphericalShellsClassification Note 30.4 FoundationsClassification Note 30.5 Environmental Conditions andEnvironmental Loads Classification Note 31.5Strength Analysis of MainStructures of Self-elevating Units Table B2 Other referencesReference TitleAISC-ASD Manual of Steel Construction ASDAPI RP 2A – WSD with supplement 1Planning, Designing and Constructing Fixed Offshore Platforms – Working Stress DesignAPI RP 2T Planning, Designing and Constructing TensionLeg PlatformsBS 7910Guide on methods for assessing the acceptability offlaws in fusion welded structuresNACE TPC Publication No. 3. The role of bacteria in corrosionof oil field equipmentSNAME 5-5A Site Specific Assessment of Mobile Jack-Up UnitsD ET N ORSKE V ERITAS。
企业能量平衡通则The general principles for energy balance ofindustrial enterprise1主题内容与适用范围本标准规定了企业进行能量平衡的原则。
企业能量平衡的目的是为改进企业能源管理、实行节能技术改造、提高能源利用率提供科学依据。
本标准适用于各类企业,事业单位也可参照使用。
2引用标准GB 3485评价企业合理用电技术导则GB 3486评价企业合理用热技术导则GB 2588设备热效率计算通则GB 2589综合能耗计算通则GB 1028工业余热术语、分类、等级及余热资源量计算方法GB 6421企业能流图绘制方法3企业能量平衡的定义企业能量平衡是以企业为对象的能量平衡,包括各种能源的收入与支出的平衡,消耗与有效利用及损失之间的数量平衡。
4企业能量平衡的方法4.1企业能量平衡采用统计计算的方法。
在统计资料不足,统计数据需要校核及特殊需要时,应进行测试。
测试结果反映的是测试状态下的水平,应折算为统计期运行状态下的平均水平。
4.2统计计算以统计期内的计量、记录及统计数据为基础进行综合计算。
5能量平衡表的编制要求5.1在企业能量平衡表的编制过程中,能源的计量、统计资料要完整无误,有关数据不得错计、漏计和重计。
5.2各种能源的实物量和折算标准煤量应有必要的分析化验等依据。
5.3能量平衡表中各种能源数量应与实际收入量相符。
各车间使用和供出的各种能源数量应与平衡表中相应的能源数量相符。
6企业能量平衡的技术指标6.1 能耗指标6.1.1产品单位产量实物能耗按式(1)计算:E m= (1)式中:E m——产品单位产量实物能耗,t(吨)(标准煤);E i——某种能源消耗量,实物单位;M——期内产出的某种产品的合格品数量,实物单位。
6.1.2单位产值(增加值)实物能耗按式(2)计算:E g= (2)式中: E g——单位产值(增加值)实物能耗,t(吨)(标准煤);G——期内产出的产值(增加值),万元。
AS/NZS 1170.0:2002(Incorporating Amendment Nos 1,2&4)Australian/New Zealand Standard ™Structural design actions Part 0:GeneralprinciplesBuildingCodeofAustralia Primaryreferenced StandardAS/NZS1170.0:2002This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee BD-006,General Design Requirements and Loading on Structures.It was approved on behalf of the Council of Standards Australia on29March2002 and on behalf of the Council of Standards New Zealand on28March2002.It was published on4June2002.The following are represented on Committee BD-006:Association of Consulting Engineers AustraliaAustralian Building Codes BoardAustralian Institute of Steel ConstructionBuilding Research Association of New ZealandCement and Concrete Association of AustraliaConcrete Masonry Association of AustraliaCSIRO,Building,Construction and EngineeringCyclone Testing Station—James Cook UniversityElectricity Supply Association of AustraliaHousing Industry AssociationInstitution of Engineers AustraliaInstitution of Professional Engineers New ZealandMaster Builders AustraliaNew Zealand Heavy Engineering Research AssociationSteel Reinforcement Institute of AustraliaUniversity of Canterbury New ZealandUniversity of MelbourneUniversity of NewcastleAdditional interests participating in the preparation of this Standard:Monash UniversityCurtin University of TechnologyKeeping Standards up-to-dateStandards are living documents which reflect progress in science,technology and systems.To maintain their currency,all Standards are periodically reviewed,and new editions are published.Between editions,amendments may be issued. Standards may also be withdrawn.It is important that readers assure themselves they are using a current Standard,which should include any amendments which may have been published since the Standard was purchased.Detailed information about joint Australian/New Zealand Standards can be found by visiting the Standards Australia web site at .au or Standards New Zealand web site at and looking up the relevant Standard in the on-line catalogue.Alternatively,both organizations publish an annual printed Catalogue with full details of all current Standards.For more frequent listings or notification of revisions,amendments and withdrawals,Standards Australia and Standards New Zealand offer a number of update options.For information about these services, users should contact their respective national Standards organization.We also welcome suggestions for improvement in our Standards,and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities.Please address your comments to the Chief Executive of either Standards Australia International or Standards New Zealand at the address shown on the back cover.This Standard was issued in draft form for comment as DR00904.AS/NZS 1170.0:2002(Incorporating Amendment Nos 1, 2 & 4)Australian/New Zealand Standard™Structural design actionsPart 0: General principlesOriginated in Australia as part of AS CA1—1933.Originated in New Zealand as part of NZS 1900:1964.Previous Australian editions AS 1170.1—1989 and AS 2867—1986.Previous New Zealand edition NZS 4203:1992.AS 1170.1—1989, AS 2867—1986, and NZS 4203:1992 jointly revised, amalgamated and redesignated in part as AS/NZS 1170.0:2002.Reissued incorporating Amendment Nos 1, 2 & 4 (April 2005)COPYRIGHT© Standards Australia/Standards New ZealandAll rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher.Jointly published by Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001 and Standards New Zealand, Private Bag 2439, Wellington 6020AS/NZS 1170.0:20022PREFACEThis Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee BD-006, General Design Requirements and Loading on Structures to supersede, in part, AS 1170.1—1989, Minimum design loads on structures, Part 1: Dead and live loads , and, in part, NZS 4203:1992, Code of practice for general structural design and design loadings for buildings, Volume 1: Code of practice and, in part, AS 2867—1986, Farm structures—General requirements for structural design .This Standard is published as a joint Standard (as are also AS/NZS 1170.1 and AS/NZS 1170.2) and it is intended that it is suitable for use in New Zealand as well as Australia.For Australia, this Standard will be referenced in the Building Code of Australia by way of BCA Amendment 11 to be published on 1 July 2002, thereby superseding in part the previous Edition, AS 1170.1—1989, which will be withdrawn 12 months from the date of publication of this edition. AS 1170.1—1989 may be used for structures not covered by the Building Code of Australia, until an Appendix is developed for inclusion in this Standard by amendment.The objective of this Standard is to provide designers with general procedures and criteria for the structural design of structures. It outlines a design methodology that is applied in accordance with established engineering principles.This Standard includes revised Clauses covering load combinations (referred to as combinations of actions) and general design and analysis clauses. It does not include values of actions (e.g. values of dead or live loads; referred to as permanent or imposed actions). This Standard is Part 0 of the 1170 series, Structural design actions , which comprises the following parts, each of which has an accompanying Commentary published as a Supplement:The Commentary to this Standard is AS/NZS 1170.0 Supp 1, Structural design actions —General principles —Commentary (Supplement to AS/NZS 1170.0:2002).This Standard is based on the philosophy and principles set out in ISO 2394:1998, General principles on reliability for structures . ISO 2394 is written specifically as a guide for the preparation of national Standards covering the design of structures. It includes methods for establishing and calibrating reliability based limit states design Standards.The terms ‘normative’ and ‘informative’ have been used in this Standard to define the application of the appendix to which they apply. A ‘normative’ appendix is an integral part of a Standard, whereas an ‘informative’ appendix is only for information and guidance.Notes to the text contain information and guidance and are not considered to be an integral part of the Standard. AS/NZS 1170.0 General principlesAS/NZS 1170.1 Permanent, imposed and other actionsAS/NZS 1170.2 Wind actionsAS/NZS 1170.3 Snow and ice actionsAS 1170.4Earthquake loads NZS 1170.5Earthquake actions – New Zealand A4 A4AS/NZS 1170.0:20023CONTENTSPage SECTION 1 SCOPE AND GENERAL1.1 SCOPE (4)1.2 APPLICATION (5)1.3 REFERENCED DOCUMENTS (5)1.4 DEFINITIONS (5)1.5 NOTATION (7)SECTION 2 STRUCTURAL DESIGN PROCEDURE2.1 GENERAL (9)2.2 ULTIMATE LIMIT STATES (9)2.3 SERVICEABILITY LIMIT STATES (10)SECTION 3 ANNUAL PROBABILITY OF EXCEEDANCE(FOR NEW ZEALAND USE ONLY)3.1 GENERAL (11)3.2 IMPORTANCE LEVELS (11)3.3 DESIGN WORKING LIFE (11)3.4 ANNUAL PROBABILITY OF EXCEEDANCE (12)SECTION 4 COMBINATIONS OF ACTIONS4.1 GENERAL (15)4.2 COMBINATIONS OF ACTIONS FOR ULTIMATE LIMIT STATES (15)4.3 COMBINATIONS OF ACTIONS FOR SERVICEABILITY LIMIT STATES (17)4.4 CYCLIC ACTIONS (17)SECTION 5 METHODS OF ANALYSIS5.1 GENERAL (18)5.2 STRUCTURAL MODELS (18)SECTION 6 STRUCTURAL ROBUSTNESS6.1 GENERAL (19)6.2 LOAD PATHS (19)SECTION 7 CONFIRMATION METHODS7.1 GENERAL (20)7.2 ULTIMATE LIMIT STATES (20)7.3 SERVICEABILITY LIMIT STATES (20)APPENDICESA SPECIAL STUDIES (21)B USE OF TEST DATA FOR DESIGN (22)C GUIDELINES FOR SERVICEABILITY LIMIT STATES (26)D FACTORS FOR USE WITH AS 1170.4—1993 (29)F ANNUAL PROBABILITY OF EXCEEDANCE(FOR AUSTRALIAN USE ONLY–STRUCTURES FOR WHICH DESIGNEVENTS ARE NOT GIVEN) (32)AS/NZS 1170.0:2002 4STANDARDS AUSTRALIA/STANDARDS NEW ZEALANDAustralian/New Zealand StandardStructural design actionsPart 0: General principlesS E C T I O N1S C O P E A N D G E N E R A L1.1 SCOPEThis Standard specifies general procedures and criteria for the structural design of a building or structure in limit states format. It covers limit states design, actions, combinations of actions, methods of analysis, robustness and confirmation of design.The Standard is applicable to the structural design of whole buildings or structures and their elements.This Standard covers the following actions:(a)Permanent action (dead load).(b)Imposed action (live load).(c)Wind.(d)Snow.(e)Earthquake.(f)Liquid pressure.(g)Ground water.(h)Rainwater ponding.(i)Earth pressure.NOTES:1Where this Standard does not give information required for design, special studies should be carried out. Guidance is given in Appendix A.2Where testing is used to determine data for design or to confirm a design, guidance on methods is given in Appendix B.3Normal design practice is that all likely actions be considered. Any actions considered in design that are not in the above list should be the subject of special studies, as they are notcovered by this Standard.4Additional information on other actions such as movement effects, construction loads and accidental actions is given in the Commentary (see Preface).5Movement effects include actions on structures resulting from expansion or contraction of materials of construction (such as those due to creep, temperature or moisture contentchanges) and also those resulting from differential ground settlement. Serviceability may beparticularly affected by such actions.6Guidance on criteria for serviceability is given in Appendix C, which have been found to be generally suitable for importance level 2 buildings. Structures of special importance orstructures where more stringent criteria are appropriate may require the stated criteria to betightened.AS/NZS 1170.0:20025 1.2 APPLICATIONThis Standard may be used as a means for demonstrating compliance with the Requirements of Part B1 of the Building Code of Australia.This Standard is intended for citation by New Zealand’s Building Industry Authority as a document that contributes towards establishing compliance with Clause B1 ‘Structure’ of the New Zealand Building Code. A code complying design is also contingent upon the Standard being used in conjunction with the appropriate material Standard and with additional approval being granted in respect of the engineering judgement calls made in the application of the Standard.1.3 REFERENCED DOCUMENTSThe following documents are referred to in this Standard:1.4 DEFINITIONSFor the purpose of this Standard the definitions below apply.1.4.1 ActionSet of concentrated or distributed forces acting on a structure (direct action), or deformation imposed on a structure or constrained within it (indirect action).NOTE: The term load is also often used to describe direct actions.1.4.2 Action effects (internal effects of actions, load effects)Internal forces and bending moments due to actions (stress resultants).1.4.3 Combination of actionsSet of design values used to confirm that the limit states are not exceeded under the simultaneous influence of different actions.1.4.4 Design action effectThe action effect computed from the design values of the actions or design loads.1.4.5 Design capacityThe product of the capacity reduction factor and the nominal capacity.1.4.6 Design situationSet of conditions for which the design is required to demonstrate that relevant limit states are not exceeded.AS 1170 Minimum design loads on structures 1170.4Part 4: Earthquake loads AS/NZS 1170 Structural design actions 1170.1 Part 1: Permanent, imposed and other actions 1170.2 Part 2: Wind actions 1170.3Part 3: Snow and ice actions NZS 1170 Structural design actions 1170.5 Part 5: Earthquake actions – New Zealand Australian Building Codes Board Building Code of Australia A4 A1 A1AS/NZS 1170.0:2002 61.4.7 Imposed actionA variable action resulting from the intended use or occupancy of the structure.1.4.8 Limit statesStates beyond which the structure no longer satisfies the design criteria.NOTE: Limit states separate desired states (compliance) from undesired states (non-compliance).1.4.9 Limit states, serviceabilityStates that correspond to conditions beyond which specified service criteria for a structure or structural element are no longer met.NOTE: The criteria are based on the intended use and may include limits on deformation, vibratory response, degradation or other physical aspects.1.4.10 Limit states, ultimateStates associated with collapse, or with other similar forms of structural failure.NOTE: This generally corresponds to the maximum load-carrying resistance of a structure or structural element but, in some cases, to the maximum applicable strain or deformation.1.4.11 LoadThe value of a force appropriate to an action.1.4.12 Permanent actionAction that is likely to act continuously and for which variations in magnitude with time are small compared with the mean value.1.4.13 Proof testingApplication of test loads to a structure, sub-structure, member or connection, to ascertain the structural characteristics of that one item under test.1.4.14 Prototype testingApplication of test loads to one or more samples of structures, sub-structures, members or connections to ascertain the structural characteristics of the population that the sample represents.1.4.15 ReliabilityAbility of a structure or structural element to fulfil the specified criteria, including the working life, for which it has been designed.NOTE: Reliability covers structural safety and serviceability, and can be expressed in terms of probability.1.4.16 ServiceabilityAbility of a structure or structural element to perform adequately for normal use under all expected actions.1.4.17 ShallIndicates that a statement is mandatory.1.4.18 ShouldIndicates a recommendation (non-mandatory).1.4.19 StructureOrganized combination of connected structural elements designed to provide some measure of resistance.AS/NZS 1170.0:200271.4.20 Structural elementPhysically distinguishable part of a structure, for example, wall, column, beam, connection.1.4.21 Structural robustnessAbility of a structure to withstand events like fire, explosion, impact or consequences ofhuman errors, without being damaged to an extent disproportionate to the original cause.1.4.22 Special studyA procedure for justifying departure from this Standard or for determining information notcovered by this Standard.NOTE: Special studies are outside the scope of this Standard.1.4.23 Design working lifeA2Duration of the period during which a structure or a structural element, when designed, isassumed to perform for its intended purpose with expected maintenance but without majorstructural repair being necessary.NOTE: In the context of this Standard, the design working life is a ‘reference period’ usuallystated in years. It is a concept that can be used to select the probability of exceedance of differentactions.1.4.24 Environmental influencesChemical, biological or physical influences on a structure, which may deteriorate thematerials constituting the structure, and which in turn may affect its reliability in anunfavourable way.1.5 NOTATIONWhere non-dimensional ratios are involved, both the numerator and denominator areexpressed in identical units.The dimensional units for length and stress in all expressions or equations are to be taken asmillimetres (mm) and megapascals (MPa) respectively, unless specifically noted otherwise.Unless otherwise stated, the notation in this Standard has the following meanings:E = action effectE = earthquake actionE s= serviceability earthquake actionE u= ultimate earthquake actionE d= design action effectE d,dst= design action effect of destabilizing actionsE d,stb= design action effect of stabilizing actionsF e= earth pressure actionF e,u= ultimate earth pressure actionF ice= ice actionF gw= ground water actionF l p= liquid pressure actionF pnd= rainwater ponding actionF sn= snow actionAS/NZS 1170.0:2002 8G = permanent action (self-weight or ‘dead’ action)k p= probability factork t= factor to allow for variability of structural unitsN = design working life of a building or structure, in yearsP = the annual probability of exceedanceP ref= reference probability of exceedance for safetyQ = imposed action (due to occupancy and use, ‘live’ action)R= nominal capacity (based on the fifth percentile strength)R d= design capacity (equal to φR)S u= ultimate value of various actions appropriate for particular combinationsV sc= coefficient of variation of structural characteristicsW = wind actionW s= serviceability wind actionW u= ultimate wind actionδ= values of the serviceability parameter determined on the basis of the design actionsδ = limiting value of the serviceability parameter (the subscript ‘ ’ stands for limiting value)φ= capacity reduction factorψc= combination factor for imposed actionψs= factor for determining frequent values (short-term) of actionsψ = factor for determining quasi-permanent values (long-term) of actionsS E C T I O N 2 S T R U C T U R A L D E S I G NP R O C E D U R E2.1 GENERALStructural design shall be carried out using the procedure given in Clause 2.2 for ultimate limit states and Clause 2.3 for serviceability limit states. 2.2 ULTIMATE LIMIT STATESDesign for ultimate limit states shall be carried out by the following procedure:(a)Adopt the importance level for the building or structure and the associated annual probability of exceedance (P ) for wind, snow and earthquake as follows: (i)For Australia—(A) structures covered by the Building Code of Australia—as given in theBuilding Code of Australia. (B) structures not covered by the Building Code of Australia and for whichno design events are specified by the applicable legislation or by other Standards—as given in Appendix F. (ii) For New Zealand—as given in Section 3.(b) Determine the permanent (G ) and imposed (Q ) loads in accordance with AS/NZS 1170.1.(c)Determine the ultimate loads for wind (W ) in accordance with AS/NZS 1170.2. (d)Determine the ultimate loads for earthquake (E u ) for Australia, in accordance with AS 1170.4 as modified by Appendix D of this Standard including the probability factor (k p ) and the changes to earthquake design category. For New Zealand determine the ultimate loads for earthquake (E u ), in accordance with NZS 1170.5. (e) Determine the ultimate loads for snow (F sn ) and ice (F ice ) in accordance with AS/NZS 1170.3.(f)Where such actions are relevant, determine the ultimate loads for liquid pressure (F l p ) ground water (F gw ) rainwater ponding (F pnd ) and earth pressure loads (F e,u ) in accordance with AS/NZS 1170.1.(g) Determine combinations of actions in accordance with Section 4.(h) Analyse the structure and its parts for the relevant combinations in accordance with Section 5.(i)Design and detail the structure in accordance with— (i)Section 6 for robustness; and(ii) for Australia, AS 1170.4 for earthquake, or (iii) for New Zealand, NZS 1170.5 for earthquake.(j) Determine the design resistance using the applicable Standard or other document. The Building Code of Australia specifies the documents to be used within its jurisdiction. (k)Confirm that the design resistance exceeds the appropriate action effects in accordance with Section 7.A4A4A1A22.3 SERVICEABILITY LIMIT STATESDesign for serviceability limit states shall be carried out by the following procedure as appropriate:(a) Determine for the whole structure and for individual elements, the type of designserviceability conditions to be considered.(b) Determine the design situation including the serviceability load event andserviceability limits for the design serviceability condition being considered (see Section 3 for New Zealand).NOTE: Guidelines for serviceability events and associated limits are given in Appendix C for loads associated with an appropriate annual probability of exceedance (P ).(c) Determine the permanent loads (G ) and serviceability imposed loads (Q ) in accordance with AS/NZS 1170.1.(d)Determine serviceability loads for wind (W ) in accordance with AS/NZS 1170.2. (e) Determine serviceability loads for snow (F sn ) and ice (F ice ) in accordance with AS/NZS 1170.3.(f)Where such actions are relevant, determine serviceability loads for liquid pressure (F l p ) ground water (F gw ) rainwater ponding (F pnd ) and earth pressure (F e,u ) in accordance with AS/NZS 1170.1.(g) Determine the applicable combinations corresponding to the selected design serviceability conditions in accordance with Section 4.(h)Model the serviceability response of the structure and its parts for the relevant combinations for each serviceability condition using methods of analysis appropriate for the serviceability limit state in accordance with Section 5.(i)Determine the serviceability response using the applicable Standard or other document. The Building Code of Australia specifies the documents to be used within its jurisdiction.(j)Confirm, in accordance with Section 7, that the modelled serviceability response does not exceed the appropriate limiting values for each of the serviceability conditions identified.A2A1S E C T I O N 3 A N N U A L P R O B A B I L I T Y O FE X C E E D A N C E(F O R N E W Z E A L A N D U S E O N L Y )3.1 GENERALThis Section shall be used to determine the annual probability of exceedance of ultimate limit state loads for New Zealand. It does not form part of the Standard for use in Australia. Structures of importance level 5 are outside the scope of this Standard and require the annual probability of load exceedance (design event) to be determined by a special study.NOTE: For buildings within Australia, refer to the Building Code of Australia.3.2 DESIGN REQUIREMENTSA structure shall be designed and constructed in such a way that it will, during its design working life, with appropriate degrees of reliability sustain all actions and environmental influences likely to occur. In particular it shall be designed as follows: (a)To withstand extreme or frequently repeated actions, or both, occurring during its construction and anticipated use (resistance, deformability and static equilibrium requirements; that is, for safety).Specifically, for earthquake actions for ultimate limit states this shall mean— (i)avoidance of collapse of the structural system;(ii) avoidance of collapse or loss of support of parts of the structure representing ahazard to human life inside and outside the structure or parts required for life safety systems; and (iii) avoidance of damage to non-structural systems necessary for the buildingevacuation procedures that renders them inoperative. (b)So that it will not be damaged to an extent disproportionate to the original cause, by events like fire, explosion, impact or consequences of human error (robustness requirement).(c)To perform adequately under all expected actions (serviceability requirement).Structural design carried out using the procedures given in Clause 2.2 for ultimate limit states and Clause 2.3 for serviceability limit states is deemed to comply with this Clause.NOTE:The design should include consideration of appropriate maintenance and the effects of environmental influences.3.3 IMPORTANCE LEVELSThe importance level of the structure shall be determined in accordance with its occupancy and use, as given in Tables 3.1 and 3.2. The Table describes, in general terms, five categories of structure and gives some examples of each. For those buildings not specifically mentioned, the designer will need to exercise judgement in assigning the appropriate level.Structures that have multiple uses shall be assigned the highest importance level applicable for any of those uses. Where access to a structure is via another structure of a lower importance level, then the importance level of the access structure shall be designated the same as the structure itself.A2A43.4 ANNUAL PROBABILITY OF EXCEEDANCE3.4.1 Ultimate limit statesFor ultimate limit states for structures of importance levels 1 to 4, the annual probability of exceedance (P) for wind, snow and earthquake loads shall be as given in Table 3.3.The design working life of structures that are erected for a number of short periods of use and dismantled between each, is equal to the total of the periods of use.3.4.2 Serviceability limit statesServiceability limit states shall include—(a) SLS1—the structure and the non-structural components do not require repair after theSLS1 earthquake, snow or wind event; and(b) SLS2 — the structure maintains operational continuity after the SLS2 earthquake. For serviceability limit states for structures of importance levels 2 to 4, the annual probability of exceedance (P) for wind, snow and earthquake loads shall be determined as given in Table 3.3.NOTE: Guidelines for limits associated with serviceability events are given in Appendix C.TABLE 3.1CONSEQUENCES OF FAILURE FOR IMPORTANCE LEVELSConsequences of failure DescriptionImportancelevelCommentLow Low consequence for loss of human life, orsmall or moderate economic, social orenvironmental consequences1Minor structures (failure not likely toendanger human life)Ordinary Medium consequence for loss of human life, orconsiderable economic, social or environmentalconsequences2Normal structures and structures notfalling into other levels3 Major structures (affecting crowds)HighHigh consequence for loss of human life, orvery great economic, social or environmentalconsequences 4Post-disaster structures (post disasterfunctions or dangerous activities)Exceptional Circumstances where reliability must be set on acase by case basis5 Exceptional structuresA2 A4TABLE 3.2IMPORTANCE LEVELS FOR BUILDING TYPES—NEW ZEALAND STRUCTURES ImportancelevelComment Examples1 Structures presenting a lowdegree of hazard to life andother property Structures with a total floor area of <30 m2Farm buildings, isolated structures, towers in rural situations Fences, masts, walls, in-ground swimming pools2 Normal structures andstructures not in otherimportance levels Buildings not included in Importance Levels 1, 3 or 4Single family dwellingsCar parking buildingsBuildings and facilities as follows:(a) Where more than 300 people can congregate in one area(b) Day care facilities with a capacity greater than 150(c) Primary school or secondary school facilities with a capacitygreater than 250(d) Colleges or adult education facilities with a capacity greater than500(e) Health care facilities with a capacity of 50 or more residentpatients but not having surgery or emergency treatment facilities (f) Airport terminals, principal railway stations with a capacitygreater than 250(g) Correctional institutions(h) Multi-occupancy residential, commercial (including shops),industrial, office and retailing buildings designed to accommodate more than 5000 people and with a gross area greater than10 000 m2(i) Public assembly buildings, theatres and cinemas of greater than1000 m23 Structures that as a wholemay contain people in crowdsor contents of high value tothe community or pose risksto people in crowdsEmergency medical and other emergency facilities not designated aspost-disasterPower-generating facilities, water treatment and waste water treatmentfacilities and other public utilities not designated as post-disasterBuildings and facilities not designated as post-disaster containinghazardous materials capable of causing hazardous conditions that do notextend beyond the property boundaries4 Structures with special post-disaster functions Buildings and facilities designated as essential facilitiesBuildings and facilities with special post-disaster functionMedical emergency or surgical facilitiesEmergency service facilities such as fire, police stations and emergency vehicle garagesUtilities or emergency supplies or installations required as backup for buildings and facilities of Importance Level 4Designated emergency shelters, designated emergency centres and ancillary facilitiesBuildings and facilities containing hazardous materials capable of causing hazardous conditions that extend beyond the property boundaries5 Special structures(outside the scope of thisStandard—acceptableprobability of failure to bedetermined by special study) Structures that have special functions or whose failure poses catastrophic risk to a large area (e.g. 100 km2) or a large number of people (e.g., 100 000)Major dams, extreme hazard facilitiesA2。
imdrf标准操作程序IMDRF/MC/N2FINAL:2020 (Edition 6)FINAL __TTitle:IMDRF Standard Operating ProceduresAuthoring Group: IMDRF Management CommitteeDate:25 September 2020Dr Choong May Ling, Mimi, IMDRF ChairThis document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum. Copyright © 2020 by the International Medical Device Regulators Forum.Table of Contents1.0Introduction . 32.0IMDRFMembership (3)2.1ManagementCommittee (3)2.2OfficialObservers (4)2.3InvitedObservers (5)2.4Regional HarmonizationInitiatives (6)2.5mittee Membership (7)2.6Working GroupMembership (7)3.0Development of TechnicalDocuments (8)3.1GeneralPrinciples (9)3.2Stage 1 – Assignment of WorkItems (9)3.3Stage 2 – DocumentDevelopment (11)3.4Stage 3 – Advancement from Working Draft to Proposed Document (12)3.5Stage 4 – Consultation on ProposedDocuments (12)3.6Stage 5 – Advancement from Proposed Document to Final Document (13)3.7Stage 6 –Publication (14)4.Development of InformationDocuments (15)5.Document StatusDesignation (15)5.1Location of DesignationCode (15)5.2Working Drafts(WD) (16)5.3Proposed Documents(PD) (16)5.4FinalDocument (16)6.0Review and Revision of IMDRFDocuments (17)6.1Maintenance of IMDRFDocuments (18)6.2IMDRF Secretariat and IMDRF Webmasterresponsibilities (18)7.0Management and Maintenance of GHTFDocuments (19)8.0Record-Keeping/ InformationArchives (20)9.0Translation of IMDRF guidance documents (21)10.0IMDRF-Related Presentations andTraining (22)11.0IMDRFLogo (22)__ ....................................................................................................................................23ANNEXA (24)ANNEXB (26)ANNEXC (28)ANNEXD (29)ANNEXE (33)ANNEXF (34)1.0 Introduction This document is intended to describe the basic procedures that the International Medical Device Regulators Forum (IMDRF) follows when revising the membership of the Management Committee, establishing mittees or Working Groups, developing IMDRF Documents or managing documents developed under the Global Harmonization Task Force (GHTF).The Operating Procedures outlined in this document, in conjunction with the Terms of Reference, are designed to be flexible so that should the need arise, the IMDRF can respond to challenges with respect to its objectives in a timely manner. 2.0 IMDRF Membership IMDRF membership criteria, roles, and responsibilities are listed in each of the Sections belowand are also outlined in Annex D.2.1 Management CommitteeThe Management Committee consists of regulatory authorities and is responsible for the oversight and decision making for all IMDRF activities.Management Committee members are voting members and are expected to attend all IMDRF Management Committee meetings which are held face to face or by teleconference as well as to ensure regular contribution to IMDRF activities and participate in at least 2/3 of the IMDRF Working Groups.Management Committee members have two (2) representatives per delegation and these representatives need to be knowledgeable on IMDRF matters.It is expected that these representatives would consistently attend subsequent IMDRF meetings and that any changes to representatives would require notification to the IMDRF Management Committee chair.In reviewing application requests for membership, the Management Committee will consider whether the regulatory authority has met each of the following requirements, including having: been a regional influence, participated in all IMDRF MC meetings (including teleconferences) for the last two (2) consecutive years, participated in a majority of Working Groups as an Official Observer for the last two (2) consecutive years, providing active contribution, and been an Official Observer forat least the last two (2) consecutive years prior to the application for membership, and sufficient capacity to chair the MC and provide the Secretariat for a year, including hosting two (2) face to face meetings and two (2) scheduled teleconferences.Having been an Official Observer for the last two (2) consecutive years prior to the application for membership, while being an essential precondition for Management Committee membership, does not give the applicant any automatic presumption of conformity with the other criteria listed above.Applications to e a Management Committee member are to be made in writing by pleting the application form (located on the IMDRF website) and sending it to the IMDRF Chair.All applications must be submitted at least two (2) months before the next management mittee meeting for consideration.The application(s) will then be reviewed by the Management Committee at the next Management Committee meeting. The Management Committee will ask the applicant to provide a presentation during that meeting. Any new Management Committee members will be approved with the unanimous agreement of existing Management Committee members.The membership of the Management Committee will be published on the IMDRF website.2.2 Official Observers Official Observers consist of Regulatory Authorities and the World Health Organization (WHO) and participate in the oversight of all IMDRF activities, but do not participate in the decision making process.Official Observers will be expected to attend all Management Committee meetings which are held face to face or by teleconference as well as to participate in IMDRF Working groups.Official Observers will be expected to maintain the confidentiality of the “closed” Management Committee meetings per the Terms of Reference document.When a discussion or portion of a Management Committee meeting is designated as “closed” Official Observers may attend.Official Observers do not participate in the decision making process. As with full members, Official Observers may have two (2) consistent representatives per delegation and these representatives need to be knowledgeable on IMDRF matters.In reviewing application requests to e an Official Observer, the Management Committee will consider whether the applicant has met each of the following requirements: being a Regulatory Authority, operating a mature or maturing system for medical device regulation which should include:o established laws and regulations for medical devices buildingsubstantially on GHTF and IMDRF foundations and principles, o proper petencies for effective implementati...。
Q1A(R2) Stability Testing of New Drug Substancesand ProductsU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)November 2003ICHRevision 2Q1A(R2) Stability Testing of New Drug Substancesand ProductsAdditional copies are available from:Office of Training and CommunicationDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448/cber/guidelines.htm.(Tel) Voice Information System at 800-835-4709 or 301-827-1800U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)November 2003ICHRevision 2TABLE OF CONTENTSI. INTRODUCTION (1) (1)A. Objectives of the Guidance (1.1) (1)B. Scope of the Guidance (1.2) (2)C. General Principles (1.3) (2)II. GUIDANCE (2) (2)A. Drug Substance (2.1) (2)1. General (2.1.1) (2)2. Stress Testing (2.1.2) (3)3. Selection of Batches (2.1.3) (3)4. Container Closure System (2.1.4) (3)5. Specification (2.1.5) (3)6. Testing Frequency (2.1.6) (4)7. Storage Conditions (2.1.7) (4)8. Stability Commitment (2.1.8) (6)9. Evaluation (2.1.9) (7)B. Drug Product (2.2) (8)1. General (2.2.1) (8)2. Photostability Testing (2.2.2) (8)3. Selection of Batches (2.2.3) (8)4. Container Closure System (2.2.4) (8)5. Specification (2.2.5) (9)6. Testing Frequency (2.2.6) (9)7. Storage Conditions (2.2.7) (10)8. Stability Commitment (2.2.8) (14)9. Evaluation (2.2.9) (15)10. Statements/Labeling (2.2.10) (16)GLOSSARY (3) (17)REFERENCES (4) (21)ATTACHMENT List Of Revision 2 Changes (22)iGuidance for Industry1Q1A(R2) Stability Testing of New DrugSubstances and ProductsThis guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the app licable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.I. INTRODUCTION (1) 2This guidance is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first published in September 1994 and revised in August 2001. The purpose of this revision is to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV. The changes made in this second revision are listed in the attachment to this guidance.A. Objectives of the Guidance (1.1)This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration application within the three regions of the European Union (EU), Japan, and the United States. It does not seek to address the testing for registration in or export to other areas of the world. The guidance exemplifies the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches ca n be used when there are scientifically justifiable reasons.1This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This docume nt was endorsed by the ICH Steering Committee at Step 4 of the ICH process, February 2003. At S tep 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.2 Arabic numbers reflect the organizational breakdown in the document endorsed by the ICH Steering Committee at Step 4 of the ICH process.1B. Scope of the Guidance (1.2)The guidance addresses the information to be submitted in registration applications for new molecular entities and associated drug products. This guidance does n ot currently seek to cover the information to be submitted for abbreviated or abridged applications, variations, or clinical trial applications.Specific details of the sampling and testing for particular dosage forms in their proposed container closures are not covered in this guidance.Further guidance on new dosage forms and on biotechnological/biological products can be found in ICH guidances Q1C Stability Testing for New Dosage Forms and Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products, respectively.C. General Principles (1.3)The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.The choice of test conditions defined in this guidance is based on an analysis of the effects of climatic conditions in the three regions of the EU, Japan, and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. This guidance addresses climatic zones I and II. The principle has been established that stability information generated in any one of the three regions of the EU, Japan, and the United States would be mutually acceptable to the other two regions, provided the information is consistent with this guidance and the labeling is in accord with national/regional requirements.FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances descri be the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.II. GUIDANCE (2)A. Drug Substance (2.1)1. General (2.1.1)Information on the stability of the drug substance is an integral part of the systematic approach to stability evaluation.22. Stress Testing (2.1.2)Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature o f the stress testing will depend on the individual drug substance and the type of drug product involved. Stress testing is likely to be carried out on a single batch of the drug substance. The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photostability testing should be an integral part of stress testing. The standard conditions for photostability testing are described in ICH Q1B Photostability Testing of New Drug Substances and Products.Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures. However, such examination may not be necessary for certain degradation products if it has been demonstrated that they are not formed under accelerated or long-term storage conditions.Results from these studies will form an integral part of the information provided to regulatory authorities.3. Selection of Batches (2.1.3)Data from formal stability studies should be provided on at least three primary batches of the drug substance. The batches should be manufactured to a minimum of pilot scale by the same synthetic route as production batches and using a method of manufacture and procedure that simulates the final process to be used for production batches. The overall quality of the batches of drug substance placed on formal stability studies should be representative of the quality of the material to be made on a production scale.Other supporting data can be provided.4. Container Closure System (2.1.4)The stability studies should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution.5. Specification (2.1.5)Specification, which is a list of tests, references to analytical procedures, and proposed acceptance criteria, is addressed in ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances and Q6B3Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Biotechnological/Biological Products. In addition, specification for degradation products in a drug substance is discussed in ICH Q3A Impurities in New Drug Substances. Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence qu ality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes. Validated stability-indicating analytical procedures should be applied. Whether and to what extent replication should be performed should depend on the results from validation studies.6. Testing Frequency (2.1.6)For long-term studies, frequency of testing should be sufficient to establish the stability profile of the drug substance. For drug substances with a proposed retest period of at least 12 months, the frequency of testing at the long-term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed retest period.At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended. Where an expectation (based on development experience) exists that the results from accelerated studies are likely to approach significant change criteria, increased testing should be conducted either by adding samples at the final time point or including a fourth time point in the study design.When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of four time points, including the initial and final time points (e.g., 0, 6, 9, 12 months), from a 12-month study is recommended.7. Storage Conditions (2.1.7)In general, a drug substance should be evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use.The long-term testing should cover a minimum of 12 months’ duration on at least three primary batches at the time of submission and should be continued for a period of time su fficient to cover the proposed retest period. Additional data accumulated during the assessment period of the registration application should be submitted to the authorities if requested. Data from the accelerated storage condition and, if appropriate, from the intermediate storage condition can be used to evaluate the effect of short-term excursions outside the label storage conditions (such as might occur during shipping).Long-term, accelerated, and, where appropriate, intermediate storage conditions for drug substances are detailed in the sections below. The general case should apply if the drug substance4is not specifically covered by a subsequent section. Alternative storage conditions can be used if justified.a. General case (2.1.7.1)Study Storage condition Minimum time period coveredby data at submission12 monthsLong-term* 25°C ± 2°C/60% RH ± 5% RHor30°C ± 2°C/65% RH ± 5% RHIntermediate** 30°C ± 2°C/65% RH ± 5% RH 6 monthsAccelerated 40°C ± 2°C/75% RH ± 5% RH 6 months* It is up to the applicant to decide whether long-term stability sturdies are performed at25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH.** If 30°C ± 2°C/65% RH ± 5% RH is the long-term condition, there is no intermediate condition.If long-term studies are conducted at 25°C ± 2°C/60% RH ± 5% RH and significant change occurs at any time during 6 months’ testing at the accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated againstsigni ficant change criteria. Testing at the intermediate storage condition should include all tests, unless otherwise justified. The initial application should include a minimum of 6 months’ data from a 12-month study at the intermediate storage condition.Significant change for a drug substance is defined as failure to meet its specification.b. Drug substances intended for storage in a refrigerator (2.1.7.2)Study Storage condition Minimum time period coveredby data at submission Long-term 5°C ± 3°C 12 monthsAccelerated 25°C ± 2°C/60% RH ± 5% RH 6 monthsData from refrigerated storage should be assessed according to the evaluation section of this guidance, except where explicitly noted below.If significant change occurs between 3 and 6 months’ testing at the accelerated storage condition, the proposed retest period should be based on the real time data available at the long-term storage condition.If significant change occurs within the first 3 months’ testing at the accelerated storageconditi on, a discussion should be provided to address the effect of short-term excursions outside the label storage condition (e.g., during shipping or handling). This discussion can be supported, if appropriate, by further testing on a single batch of the drug substance for a period shorter than53 months but with more frequent testing than usual. It is considered unnecessary to continue to test a drug substance through 6 months when a significant change has occurred within the first 3 months.c. Drug substances intended for storage in a freezer (2.1.7.3)Study Storage condition Minimum time period coveredby data at submission Long-term -20°C ± 5°C 12 monthsFor drug substances intended for storage in a freezer, the retest period should be based on the real time data obtained at the long-term storage condition. In the absence of an accelerated storage condition for drug substances intended to be stored in a freezer, testing on a single batch at an elevated temperature (e.g., 5°C ± 3°C or 25°C ± 2°C) for an appropriate time period should be conducted to address the effect of short-term excursions outside the proposed label storage condition (e.g., during shipping or handling).d. Drug substances intended for storage below -20°C (2.1.7.4)Drug substances intended for storage below -20°C should be treated on a case-by-case basis.8. Stability Commitment (2.1.8)When available long-term stability data on primary batches do not cover the proposed retest period granted at the time of approval, a commitment should be made to continue the stability studies postapproval to firmly establish the retest period.Where the submission includes long-term stability data on three production batches covering the proposed retest period, a postapproval commitment is considered unnecessary. Otherwise, one of the following commitments should be made:• If the submission includes data from stability studies on at least three production batches, a commitment should be made to continue these studies through theproposed retest period.• If the submission includes data from stability studies on fewer than three production batches, a commitment should be made to continue these studiesthrough the proposed retest period and to place additional production batches, to atotal of at least three, on long-term stability studies through the proposed retestperiod.• If the submission does not include stability data on production batches, a commitment should be made to place the first three production batches on long-term stability studies through the proposed retest period.6The stability protocol used for long-term studies for the stability commitment should be the same as that for the primary batches, unless otherwise scientifically justified.9. Evaluation (2.1.9)The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests), a retest period applicable to all future batches of the drug substance manufactured under similar circumstances. The degree of variability of individual batches affects the confidence that a future production batch will remain within specification throughout the assigned re test period.The data may show so little degradation and so little variability that it is apparent from looking at the data that the requested retest period will be granted. Under these circumstances, it is normally unnecessary to go through the formal statistical analysis; providing a justification for the omission should be sufficient.An approach for analyzing the data on a quantitative attribute that is expected to change with time is to determine the time at which the 95 percent, one-sided confidence limit for the mean curve intersects the acceptance criterion. If analysis shows that the batch-to-batch variability is small, it is advantageous to combine the data into one overall estimate. This can be done by first applying appropriate statistical tests (e.g., p values for level of significance of rejection of more than 0.25) to the slopes of the regression lines and zero time intercepts for the individual batches. If it is inappropriate to combine data from several batches, the overall retest period should be based on the minimum time a batch can be expected to remain within acceptance criteria.The nature of any degradation relationship will determine whether the data should be transformed for linear regression analysis. Usually the relationship ca n be represented by a linear, quadratic, or cubic function on an arithmetic or logarithmic scale. Statistical methods should be employed to test the goodness of fit of the data on all batches and combined batches (where appropriate) to the assumed degradation line or curve.Limited extrapolation of the real time data from the long-term storage condition beyond the observed range to extend the retest period can be undertaken at approval time if justified. This justification should be based, for example, o n what is known about the mechanism of degradation, the results of testing under accelerated conditions, the goodness of fit of any mathematical model, batch size, and/or existence of supporting stability data. However, this extrapolation assumes that the same degradation relationship will continue to apply beyond the observed data.Any evaluation should cover not only the assay, but also the levels of degradation products and other appropriate attributes.710. Statements/Labeling (2.1.10)A storage statement should be established for the labeling in accordance with relevantnational/regional requirements. The statement should be based on the stability evaluation of the drug substance. Where applicable, specific instructions should be provided, particul a rly for drug substances that cannot tolerate freezing. Terms such as ambient conditions or room temperature should be avoided.A retest period should be derived from the stability information, and a retest date should be displayed on the container label if appropriate.B. Drug Product (2.2)1. General (2.2.1)The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance, results from stability studies on the drug substance, and experience gained from clinical formulation studies. The likely changes on storage and the rationale for the selection of attributes to be tested in the formal stability studies should be stated.2. Photostability Testing (2.2.2)Photostability testing should be conducted on at least one primary batch of the drug product if appropriate. The standard conditions for photostability testing are described in ICH Q1B.3. Selection of Batches (2.2.3)Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing. The manufacturing process used for primary batches should simulate that to be applied to production batches and should provide product of the same quality and meeting the same specification as that intended for marketing. Two of the three batches should be at least pilot scale batches, and the third one can be smaller if justified. Where possible, batches of the drug product should be manufactured by using different batches of the drug substance.Stability studies should be performed on each individual strength and container size of the drug product unless bracketing or matrixing is applied.Other supporting data can be provided.4. Container Closure System (2.2.4)Stability testing should be conducted on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any se condary packaging and8container label). Any available studies carried out on the drug product outside its immediate container or in other packaging materials can form a useful part of the stress testing of the dosage form or can be considered as supporting information, respectively.5. Specification (2.2.5)Specification, which is a list of tests, references to analytical procedures, and proposed acceptance criteria, including the concept of different acceptance criteria for release and shelf life specifications, is addressed in ICH Q6A and Q6B. In addition, specification for degradation products in a drug product is addressed in ICH Q3B Impurities in New Drug Products.Stability studies should include testing of those attributes of the drug product tha t are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), and functionality tests (e.g., for a dose delivery system). Analytical procedures should be fully validated and stability indicating. Whether and to what extent replication should be performed will depend on the results of validation studies.Shelf life acceptance criteria should be derived from consideration of all available stability information. It may be appropriate to have justifiable differences between the shelf life and release acceptance criteria based on the stability evaluation and the changes observed on storage. Any differences between the release and shelf life acceptance criteria for antimicrobial preservative content should be supported by a validated correlation of chemical content and preservative effectiveness demonstrated during drug development on the product in its final formulation (except for preservative concentration) intended for marketing. A single primary stability batch of the drug product should be tested for antimicrobial preservative effecti v eness (in addition to preservative content) at the proposed shelf life for verification purposes, regardless of whether there is a difference between the release and shelf life acceptance criteria for preservative content.6. Testing Frequency (2.2.6)For long-term studies, frequency of testing should be sufficient to establish the stability profile of the drug product. For products with a proposed shelf life of at least 12 months, the frequency of testing at the long-term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed shelf life.At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended. Where an expectation (based on development experience) exists that results from accelerated testing are likely to approach significant change criteria, increased testing should be conducted either by adding samples at the final time point or by including a fourth time point in the study design.9When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of four time points, including the initial and final time points (e.g., 0, 6, 9, 12 months), from a 12-month study is recommended.Reduced designs (i.e., matrixing or bracketing), where the testing frequency is reduced or certain factor combinations are not tested at all, can be applied if justified.7. Storage Conditions (2.2.7)In general, a drug product should be evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture or potential for solvent loss. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use.Stability testing of the drug product after constitution or dilution, if applicable, should be conducted to provide information for the labeling on the preparation, storage condition, and in-use period of the constituted or diluted product. This testing should be performed on the constituted or diluted product through the proposed in-use period on primary batches as part of the formal stability studies at initial and final time points, and if full shelf life, long-term datawill not be available before submission, at 12 months or the last time point for which data will be available. In general, thi s testing need not be repeated on commitment batches.The long-term testing should cover a minimum of 12 months’ duration on at least three primary batches at the time of submission and should be continued for a period of time sufficient to cover the proposed shelf life. Additional data accumulated during the assessment period of the registration application should be submitted to the authorities if requested. Data from the accelerated storage condition and, if appropriate, from the intermediate storage condition can be used to evaluate the effect of short-term excursions outside the label storage conditions (such as might occur during shipping).Long-term, accelerated, and, where appropriate, intermediate storage conditions for drug products are detailed in the sections below. The general case should apply if the drug product is not specifically covered by a subsequent section. Alternative storage conditions can be used if justified.10。
日本标准JIS大全序号标准号标准名称1 JIS K 8833-1978 糠醛(FURFURAL)2 JIS Z 3233 ERRATUM 1- 惰性气体保护弧焊用钨焊条(勘误1)((Erratum 1))3 JIS G 3303 ERRATUM 1- JIS G3303的技术勘误1(ERRATUM)4 JIS W 0812-1993 飞行设备的环境条件和试验程序(RTCA/DC-160C)(Airborne equipment -- Environmental conditions and test procedures (RTCA/DC - 160C))5 JIS B 8367-5- 液压气缸的安装尺寸第5部分:单棒10 MPa系列、方盖、带棒紧型液压气缸(钻孔40 mm 至200 mm) (Mounting dimensions for hydraulic cylinders -- Part 5: Single rod -- 10 MPa series square cover and tie rod tightend type (Bores from 40 mm to 200 mm))6 JIS K 9517-1992 锌(Zincon)7 JIS K 8370-1992 铜(III)乙酸酯(Copper (II) acetate monohydrate)8 JIS K 4814-1969 苦味酸(246-三硝基苯酚)(Picric acid)9 JIS K 9053-1993 L-赖氨酸-盐酸盐(L(+)-lysine hydrochloride)10 JIS K 8453-1994 二乙醇胺(22-Iminodiethanol)11 JIS K 8695-1981 苯并[F]喹啉(Benzo (f) quinoline)12 JIS H 2105-1955 铅锭(Pig lead)13 JIS K 8824-1992 D(+)葡萄糖(D(+)-glucose)14 JIS L 2401-1992 黄麻纱(Jute yarns)15 JIS X 5101-1982 25路数据电路端接设备与数据终端设备间的接口(The Interface between Data Circuit Terminating Equipment (DCE) and Data Terminal Equipment (DTE) (25-pin Interface))16 JIS F 3425-1999 船用信号旗滑车(Ships steel blocks for signal flags)17 JIS K 8879-1994 试镁灵(Magneson)18 JIS B 1196- 焊接螺母(Weld nuts)19 JIS K 9024-1991 磷钨酸(12 TUNGSTO(VI) PHOSPHORIC ACID N-HYDRATE (PHOSPHOTUNGSTIC ACID))20 JIS K 2219-1993 齿轮油(GEAR OILS)21 JIS B 9650-2 ERRATUM 1- JIS B9650-2的技术勘误1(ERRATUM)22 JIS L 4112- 儿童开襟衬衣及青年开襟衬衣(Boys and youths open shirts)23 JIS F 3436-1980 船用小型钢索卷车(Ships small size wire reels)24 JIS B 9650-1 ERRATUM 1- JIS B9650-1的技术勘误1(ERRATUM)25 JIS F 3443-1995 船用小型钢制滑轮(Ships small size steel blocks)26 JIS F 3430-1980 船用钢索卷筒(Ships wire reels)27 JIS B 2351-1990 25MPa(250Kgf/cm2)液压用卡套式管接头(25 MPa (250 kgf/cm2) bite type tube fittings for hydraulic use)28 JIS F 2416-1982 船用灭火器(Ships flame arresters)29 JIS F 2106-1995 船用普通链条(Ships chains for general use)30 JIS Q 10006 ERRATUM 1- JIS Q10006的技术勘误1(ERRATUM)31 JIS A 1112 ERRATUM 1- JIS A1112的技术勘误1(ERRATUM)32 JIS K 9032-1995 间苯二酚(RESORCINOL)33 JIS T 5601-1993 牙科操作用椅(DENTAL OPERATORS STOOL)34 JIS C 2805 ERRATUM 1- JIS C2805的技术勘误1(ERRATUM)35 JIS A 5422 ERRATUM 1- 勘误1((Erratum 1))36 JIS L 0216-1990 羽毛术语集(Glossary of terms used in feathers)37 JIS S 6037- 划线笔(Marking pens)38 JIS C 0364-4-41 AMD 2- 建筑物的电气装置第4部分:安全防护41章:电冲击防护(修改 2)(Electrical installations of buildings -- Part 4: Protection for safety -- Chapter 41: Protection against electric shock (Amendment 2))39 JIS K 2541-1996 原油和石油产品硫含量的测定(Crude oil and petroleum products -- Determination of sulfur content)40 JIS R 3418-1991 窗扉和帷幔用玻璃纤维布窗帘(Textile glass fabric curtains for casement and drapery)41 JIS R 5203-1995 水泥的水合热的测试方法(Testing method for heat of hydration of cement)42 JIS Z 8809 ERRATUM 1- 校准粘度计用标准液(勘误1)(Standard liquids for calibrating viscometers (Erratum 1))43 JIS B 9658-1990 精米机械安全及设计卫生标准(Design rules for safety and sanitation of rice milling machinery)44 JIS B 4142- 金刚石/CBN制品安全要求(Diamond/CBN products -- Safety requirements)45 JIS M 8231-1982 锰矿石中化合水含量的测定方法(Methods for determination of combined water in manganese ores)46 JIS T 5420- 牙周刮器Gr型(Periodontal curettes -- Gr-type)47 JIS T 6116- 牙科铸造用金合金(Dental casting gold alloys)48 JIS M 8213-1995 铁矿石酸溶铁(II)含量测定方法(Iron ores -- Method for determination of acid soluble iron (II) content)49 JIS L 2510 ERRATUM 1- 尼龙缝纫线(勘误1)(Nylon sewing thread (Erratum 1))50 JIS Z 1703-1976 聚乙烯瓶(Polyethylene bottles)51 JIS R 1632-1998 精细陶瓷静态挠曲疲劳的试验方法(Test methods for static bending fatigue of fine ceramics)52 JIS P 5102-1992 打字机用复写纸(Stencil paper for typewriter)53 JIS K 2280-1996 石油产品燃料辛烷值、十六烷值的测定和十六烷系数的计算方法(Petroleum products -- Fuels -- Determination of octane number cetane number and calculation of cetane index)54 JIS T 1190-1987 重心稳定性测定仪(Stabilometers)55 JIS Z 0650-1995 成组货件系统的通用规则(GENERAL RULES FOR UNIT-LOADSYSTEM)56 JIS Z 1624-1994 国际贸易用罐式液体和气体集装箱(Tank containers for liquids and gases for international trade)57 JIS S 5506-1994 办公用卷宗(文件夹和导卡)(Office files (Folder and guide))58 JIS Z 6000-1996 显微学词汇(Micrographics -- Vocabulary)59 JIS Z 4921-1994 X射线管电压测定器(Measuring devices for X-ray tube voltage)60 JIS Z 4819-1995 辐射屏蔽垫(Radiation shielding mats)61 JIS K 5101-1-4- 颜料试验方法第1部分:分散特性评估的分散方法第4节:钢珠研磨机(Test methods for pigments -- Part 1: Methods of dispersion for assessment of dispersion characteristics -- Section 4: A bead mill)62 JIS K 2204-1997 柴油燃料(Diesel fuel)63 JIS C 0447-1997 人机界面(MMI)驱动原理(Man-machine interface (MMI) -- Actuating principles)64 JIS K 7154-1- 塑料热固性粉末模塑复合物(PMCs)试样的注射模塑成形第1部分:一般原则和多用途试样的模塑成形(Plastics -- Injection moulding of test specimens of thermosetting powder moulding compounds (PMCs) -- Part 1: General principles and moulding of multipurpose test specimens)65 JIS T 1453-1998 高频外科手术(High frequency surgical equipment)66 JIS Z 8202-3- 量值和单位第3部分:力学(Quantities and units -- Part 3: Mechanics)67 JIS K 3363-1990 合成洗涤剂生物降解度的试验方法(Testing method for biodegradability of synthetic detergent)68 JIS Q 14010-1996 环境审核指南总原则(Guidelines for environmental auditing -- General principles)69 JIS K 8968-1980 硫酸钴(二价)七水化合物(Cobalt(ii) sulfateheptahydrate)70 JIS B 7432-1985 角度标准用多面镜(Optical polygons for angle standards)71 JIS A 5525-1994 钢管桩(Steel pipe piles)72 JIS Z 2342- 压力试验过程中压力容器的声波发射试验方法和试验结果的分类(Methods for acoustic emission testing of pressure vessels during pressure tests and classification of test results)73 JIS C 1010-1-1998 测量、控制和实验室用电气设备的安全要求第1部分:一般要求(Safety requirements for electrical equipment for measurement control and laboratory use -- Part 1: General requirements)74 JIS Q 9004 ERRATUM 2- 质量管理体系性能提高导则(勘误2)(Quality management systems -- Guidelines for performance improvements (Erratum 2))75 JIS R 7603-1999 碳纤维密度测定(Carbon fiber -- Determination of density)76 JIS A 1104-1999 集料的单容重和集料实积率的测定方法(Methods of test for bulk density of aggregates and solid content in aggregates)77 JIS Z 8719 ERRATUM 1- 条件配色指数发光物颜色改变的条件配色度评价方法(勘误1)(Metamerism index -- Evaluation method of degree of metamerism for change in illuminant (Erratum 1))78 JIS C 6183-1992 纤维光学波谱分析仪的试验方法(Test methods of fiber-optic spectrum analyzer)79 JIS C 0364-4-473-1999 建筑物的电气安装第4部分:安全防护第47章:安全防护测量的应用第473节:过电流防护测量(Electrical installations of buildings Part 4: Protection for safety Chapter 47: Application of protective measures for safety Section 473: Measures of protection against overcurrent)80 JIS R 3203-1999 压花玻璃(Patterned glass)81 JIS B 7755-1993 金属材料用冲击试验机械装置(Impact testing machines for metallic materials -- Instrumentation)82 JIS A 5451-1995 石棉衬板(Rock wool sheathing boards)83 JIS A 6602-1996 联排式房屋用金属屋顶组件(Metal roof components for terrace)84 JIS K 5600-5-4 ERRATUM 2- 涂料试验方法第5部分:膜的机械特性第4节:刮擦硬度(铅笔法)(勘误1)(Testing methods for paints -- Part 5: Mechanical property of film -- Section 4: Scratch hardness (Pencil method) (Erratum 2))85 JIS A 6510-1994 建筑构件(钢制屋顶装配板)(Building components (Steel panel for roof))86 JIS A 8421-2-1998 土方机械装载机第2部分:规范的标准格式和试验方法(Earth-moving machinery -- Loaders -- Part 2: Standard form of specifications and testing methods)87 JIS F 7231- 造船钢制管形起动用压缩空气储罐(Shipbuilding -- Steel tube starting air reservoirs)88 JIS B 8279- 压力容器罩(Jacket for pressure vessels)89 JIS R 3416- 成品纺织玻璃纤维织物(Finished textile glass fabrics)90 JIS R 3422-1995 织物加工玻璃带(Textile finished glass tapes)91 JIS X 5802-1994 信息技术报文通信信息定向型文本交换系统(MOTIS)第2部分:整体结构(Information technology -- Text Communication -- Message -- Oriented Text Interchange Systems (MOTIS) -- Part 2: Overall Architecture) 92 JIS C 5610-1996 集成电路术语汇编(Glossary of terms used in integrated circuits)93 JIS K 5101-11-2- 颜料试验方法第11部分:密度第2节:离心脱气法(Test methods for pigments -- Part 11:Density -- Section 2: Centrifugaldegassing method)94 JIS Z 6001 ERRATUM 1- 缩微照相透明A6型缩微胶片图像排列(勘误1)(Micrographics -- Transparent A6 microfiche -- Image arrangements (Erratum 1))95 JIS H 4040 ERRATUM 2- 铝和铝合金杆材、棒材、丝材(勘误2)(Aluminium and aluminium alloy rods bars and wires (Erratum 2))96 JIS C 0031-1995 环境试验第2部分:试验试验Z/BM:干热、低压复合试验方法(Environmental testing Part 2: Tests test Z/BM: Combined dry heat/low air pressure tests)97 JIS K 6347-3- 液化石油气用橡胶软管第3部分:分配软管及软管组合件规范(Rubber hoses for liquefied petroleum gases (LPGs) -- Part 3: Dispensing hoses and hose assemblies -- Specification)98 JIS C 5101-18-1999 电子设备用固定电容器第18部分:分规范:用固体(MnO2)和非固体作为电解质的固定式铝电解质片层电容器(Fixed capacitors for use in electronic equipment Part 18: Sectional specification: Fixed aluminium electrolytic chip capacitors with solid (MnO2) and non-solid electrolyte)99 JIS C 0035-1996 环境试验第2部分:试验方法试验Z//ABDM:气候序列(Environmental testing Part 2: Test methods Test Z/ABDM: Climatic sequence)100 JIS C 8953-1993 光伏特性排列I-V的现场测量(On-site measurements of photovoltaic array I-V characteristics)序号标准号标准名称1 JIS S 6007- 黑板(Chalkboards)2 JIS C 0061- 火焰危害试验第2部分:试验方法第2节:针焰(喷射燃烧器)试验(Fire hazard testing -- Part 2: Test methods -- Section 2 --Needle-flame test)3 JIS K0107- 废气中氯化氢含量的测定方法(Methods for determination of hydrogen chloride in flue gas)4 JIS B 8656- 比例电动液压旁通流量控制阀试验方法(Test methods for electro-hydraulic proportional bypass flow control valves)5 JIS B 0135-1993 起重机术语分类(GLOSSARY OF TERMS RELATING TO CRANES - KINDS OF CRANES)6 JIS B 8623- 冷凝机组的试验方法(Testing methods of refrigerant condensing units)7 JIS K 6766-1977 金属表面的聚乙烯薄膜的试验方法(Testing methods for polyethylene coatings on metals)8 JIS K 0115-1992 分子吸收光度分析方法通则(General rules for molecular absorptiometric analysis)9 JIS T 7324-1989 医疗用小型高压蒸汽灭菌器(High-pressure steam sterilizers for medical use (small size))10 JIS Z 4701-1997 医用X射线装置通则(General rules for medical X-ray equipment)11 JIS B 0176-3- 螺纹加工刀词汇第3部分:槽(Threading tools -- Vocabulary Part 3: Chaser)12 JIS G 3352- 冷弯波纹钢板(Steel Decks)13 JIS B 7222-1991 16mm电影胶片的卷取装置及影片盘用轴尺寸(Spindles for 16 mm motion picture film spools and reels -- Dimensions)14 JIS L 1018 ERRATUM 1- 针织物试验方法(勘误 1)(Test methods for knitted fabrics (Erratum 1))15 JIS C 3662-6- 额定电压450/750V及以下的聚氯乙烯绝缘电缆第6部分:电梯电缆和软连接用电缆(Polyvinyl chloride insulated cables of ratedvoltages up to and including 450/750 V -- Part 6: Lift cables and cables for flexible connections)16 JIS B 7110-1993 照相摄影中用玻璃滤色镜通用规范(Photographic glass filters -- General requirement)17 JIS B 7164-1997 16mm电影放映机(16 mm motion-picture projectors)18 JIS A 1129-1993 灰浆和混凝土长度变化的试验方法(Methods of test for length change of mortar and concrete)19 JIS A 1226- 土壤灼烧损伤的试验方法(Test method for ignition loss of soils)20 JIS B 1091- 紧固件验收检验(Fasteners -- Acceptance inspection)21 JIS Z 8750-1994 真空计校准方法(Methods of calibration for vacuum gauges)22 JIS M 7653-1996 便携式可燃气检测器(Portable type combustible gas detector)23 JIS X 4350-3- 信息技术JPEG 图像编码系统第3部分:移动JPEG (Information technology -- JPEG Image coding system -- Part 3: Motion JPEG )24 JIS M 7650-1993 测长式一氧化碳探测器(Detector tube type carbon monoxide measuring instruments (Length-of-stain))25 JIS M 8701-1996 铁矿石手工取样方法(Iron ores -- Increment sampling -- Manual method)26 JIS Z 7302-4 ERRATUM 1- 来自于密化垃圾的燃料第4部分:灰分的测试方法(勘误1)(Densified refuse derived fuel -- Part 4: Test method for ash (Erratum 1))27 JIS A 8306-1990 土方机械工作部件移动时间的测量方法(Earth-moving machinery -- Test method for measurement of tool movement time)28 JIS A 1455- 地板覆盖物和已安装地板的抗静电效果测量和评价方法(Anti-static effect of floor coverings and installed floors -- Methods of measurement and evaluation)29 JIS B 7725-1997 维氏硬度试验试验机的验证(Vickers hardness test -- Verification of testing machines)30 JIS B 7410-1997 石油产品试验用玻璃温度计(Liquid-in-glass thermometers for testing of petroleum products)31 JIS C 3005 ERRATUM 1- 橡胶或塑料绝缘线及电缆的试验方法(勘误1)(Test methods for rubber or plastic insulated wires and cables (Erratum 1))32 JIS K 5600-2-4-1999 涂料试验方法第2部分:涂料的特性和稳定性第4节:密度(Testing methods for paints -- Part 2: Characteristics and stability of paints -- Section 4: Density)33 JIS Z 3420- 金属材料焊接过程的规范及认可总则(Specification and approval of welding procedures for metallic materials -- General rules)34 JIS K 6890-1995 聚四氟乙烯管材(POLYTETRAFLUOROETHYLENE TUBES)35 JIS A 5361 ERRATUM 1- 预制混凝土制品分类、命名和标记的通用规则(勘误1)(Precast concrete products -- General rules for classification designation and marking (Erratum 1))36 JIS L 1917- 由于织物表面硫的燃烧的试验方法(Testing method for burning due to surface flash of textiles)37 JIS C 8280- 爱迪生螺口灯座(Edison screw lampholders)38 JIS K 7557-1996 X射线用测辐射胶片(Badge films for X-rays)39 JIS K 5600-4-2-1999 涂料试验方法第4部分:膜的视觉特性第2节:遮盖力(深色涂料用)(Testing methods for paints -- Part 4: Visual characteristics of film -- Section 2: Hiding power (for dark-coloured paints))40 JIS K 5600-1-1-1999 涂料的试验方法第1部分:一般规则第1节:一般试验方法(调合和方法) (Testing methods for paints -- Part 1: General rule -- Section 1: General test methods (conditions and methods))41 JIS Z 8102 ERRATUM 1- 不发光体颜色的名字(勘误1)(Names of non-luminous object colours (Erratum 1))42 JIS K 7244-6-1999 塑料动态力学性能的测定第6部分:剪力振动非共振法(Plastics -- Determination of dynamic mechanical properties -- Part 6: Shear vibration -- Non-resonance method)43 JIS S 0012- 包括老年人和残疾人在内的人群指南消费产品的可用性(Guidelines for all people including elderly and people with disabilities -- Usability of consumer products)44 JIS K 5633- 浸蚀性底漆(Etching primer)45 JIS K 7384- 塑料试验用聚氯乙烯(PVC)糊状物的制备行星式混合器法(Plastics -- Preparation of PVC pastes for test purposes -- Planetary-mixer method)46 JIS B 0001 ERRATUM 1- 机械工程技术制图(勘误1)(Technical drawings for Mechanical Engineering (Erratum 1))47 JIS K 4126-1995 苯甲醛(Benzaldehyde)48 JIS K1201-2- 工业用碳酸钠第2部分:250℃时非挥发性物质质量损失的测定(Sodium carbonate for industrial use -- Part 2: Determination of loss of mass and of non-volatile matter at 250 degree C)49 JIS A 5537 ERRATUM 1- JIS A5537的技术勘误1(JIS A 5537: /Erratum)50 JIS K 4135-1995 7-氨基-4-羟基-2-萘磺酸(J-酸) (7-Amino-4-hydroxy-2-naphthalene sulfonic acid (j-acid))51 JIS T 1117-1988 长时间心电图携带式记录装置(电量心电仪)(Ambulatory ECG recording system (holter system))52 JIS D 5712-1973 汽车警报蜂鸣器(Warning buzzers for automobiles)53 JIS K 5600-4-4-1999 涂料试验方法:第4部分:膜的视觉特性第4节:比色法(原理)(Testing methods for paints -- Part 4: Visual characteristics of film -- Section 4: Colorimetry (Principles))54 JIS K 0142- 表面化学分析信息格式(Surface chemical analysis -- Information formats)55 JIS L 0868-1995 耐甲醛色牢度试验方法(Test method for colour fastness to formaldehyde)56 JIS M 8100-1992 松散物料取样方法通则(Particulate materials -- General rules for methods of sampling)57 JIS D 0111-1992 与汽车悬挂装置有关的术语汇编(Glossary of terms relating to suspension of automobiles)58 JIS B 9514- 记时器性能检验方法(Test methods for time recorders)59 JIS Z 4808- 操作放射性物质的手套箱(Glove box for handling of radioactive substance)60 JIS H 1067- 铜中氧含量的测定方法(Methods for determination of oxygen in copper)61 JIS K 1501-1993 甲醇(Methanol)62 JIS K 5600-3-6-1999 涂料试验方法第3部分:成膜性第6节:涂料弗里试验(Testing methods for paints -- Part 3: Film formability -- Section 6: Print free test)63 JIS K 7139-1996 塑料多用途试样(Plastics -- Multipurpose test specimens)64 JIS S 5002-1995 粗帆布靴和鞋(Canvas boots and shoes)65 JIS B 6157-1993 永磁卡盘(PERMANENT MAGNETIC CHUCKS)66 JIS C 3006 ERRATUM 1- 纤维或纸绝缘线的试验方法(勘误 1)(Methods of test for fiber or paper insulated wires (Erratum 1))67 JIS K 5552- 富锌底漆(Zinc rich primer)68 JIS K 5101-1991 颜料试验方法(Methods of test for pigments)69 JIS C 8432-1999 非塑化聚氯乙烯(PVC-U)导管配件(Fittings of unplasticized polyvinyl chloride (PVC-U) conduits)70 JIS G 7125- 机械加工用空心钢棒(ISO规范)(Hollow steel bars for machining (ISO specifications))71 JIS A 1112- 新浇混凝土的冲洗分析试验方法(Method of test for washing analysis of fresh concrete)72 JIS X 0811 ERRATUM 1- GEDI通用电子文献交换(勘误1)(GEDI -- Generic Electronic Document Interchange (Erratum 1))73 JIS K 7081-1993 碳纤维增强塑料暴露在自然气候下的试验方法(Testing method for exposure to natural weathering of carbon fibre reinforced plastic)74 JIS K 7240-1999 塑料酚-甲醛模塑游离酚的测定碘量法(Plastics -- Phenol-formaldehyde mouldings -- Determination of free phenols -- Iodometric method)75 JIS L 0212-2-1999 织物术语汇编(不包括衣物)第2部分:室内装饰品(Glossary of textile terms (except clothes) -- Part 2: Textile interior products)76 JIS K 2536-5- 液态石油产品成分的测试方法第5部分:用气相色谱法测定氧化物含量(Liquid petroleum products -- Testing method of components Part 5: Determination of oxygenate compounds by gas chromatography) 77 JIS K 5628- 铅丹铬酸锌防腐涂料(Red-lead zinc chromate anticorrosive paint)78 JIS Z3198-4- 无铅焊剂的试验方法第4部分:用湿平衡法和接触角法测试钎焊性的试验方法(Test methods for lead-free solders -- Part 4: Methods for solderbility test by a wetting balance method and a contact angle method)79 JIS B 2704 ERRATUM 1- 螺旋压缩与拉伸弹簧设计要求和性能试验方法(勘误1)(Helical compression and extension springs -- Requirements for design performance test method (Erratum 1))80 JIS C8283-1- 家用和类似通用器具耦合器第1部分:一般要求(Appliances couplers for household and similar general purposes -- Part 1: General requirements)81 JIS K9806 ERRATUM 1- 三羟基(N-(三(羟基)甲基)甘氨酸)(勘误1)(Tricine(N-(Tris(hydroxymethyl)methyl)glycine) (Erratum 1))82 JIS K7085-1993 碳纤维增强塑料的多轴向冲击特性的试验方法(Testing method for multiaxial impact behaviour of carbon fibre reinforced plastics)83 JIS K8575-1994 氢氧化钙(CALCIUM HYDROXIDE)84 JIS K8980-1995 硫酸汞(II)试剂(MERCURY (II) SULFATE)85 JIS T3205-1980 尿道注入器(Urethral injection syringe)86 JIS K 5600-3-4-1999 涂料试验方法第3部分:成膜性第4节:涂于某一表面的产品的亲合性评估(Testing methods for paints -- Part 3: Film formability -- Section 4: Evaluation of the compatibility of product witha surface to be painted)87 JIS K 5600-4-6-1999 涂料试验方法:第4部分:膜的视觉特性第6节:比色法(颜色差别的计算)(Testing methods for paints -- Part 4: Visual characteristics of film -- Section 6: Colorimetry (Calculation of colour differences))88 JIS B 3700-225- 工业自动化系统和集成产品数据的表示和交换第225部分:应用协议:用明确形状表示的建筑部件(Industrial automation systems and integration -- Product data representation and exchange -- Part 225: Application protocol: Building elements using explicit shape representation)89 JIS K 4147-1995 5-氨基-2-氯甲苯-4-磺酸(C酸)(5-Amino-2-chlorotoluene-4-sulfonic acid (C acid))90 JIS D 0006-2- 土方机械引擎第2部分:柴油机试验方法和规范的标准格式(Earth-moving machinery -- Engines -- Part 2: Standard format of specifications and tests methods of diesel engines)91 JIS D9112-1991 自行车轮胎尺寸(Cycle -- Tyres -- Dimensions)92 JIS B 8605- 致冷装置的截止阀(Stop valves for refrigerants)93 JIS B 5119- 成型模用圆定位部件和垫块(Round locating elements and spacers for moulds)94 JIS K 4165-1995 7-苯胺基-4羟基-2-萘磺酸(苯基J 酸)(7-Anilino-4-hydroxy-2-naphthalenesulfonic acid (Phenyl J-acid)) 95 JIS K 1409-1994 化学纤维用二氧化钛(Titanium dioxide for chemical fiber)96 JIS Z 3060- 铁素体钢焊缝的超声检验方法(Method for ultrasonic examination for welds of ferritic steel)97 JIS K 3361-1979 化学纤维用高级醇类整理剂的试验方法(Method of testing for finishing agent of higher alcohols for synthetic fibers) 98 JIS E 4010-1985 铁路车辆及铁路车辆零部件的符号(Symbols for railway rolling stock and railway rolling stock parts)99 JIS E 2101-1990 带沟硬铜滑接导线(Hard-drawn grooved trolley wires) 100 JIS K 5600-5-4-1999 涂料试验方法:第5部分:膜的机械特性第4节:刮擦硬度(铅笔法)(Testing methods for paints -- Part 5: Mechanical property of film -- Section 4: Scratch hardness (Pencil method)序号标准号标准名称1 JIS Z 3201- 低碳钢用气焊条(Gas welding rods for mild steel)2 JIS K 7209- 塑料吸水率的测定(Plastics -- Determination of waterabsorption)3 JIS K 7113-1995 塑料抗拉伸性的试验方法(Testing method for tensile properties of plastics)4 JIS K 3810-2- 支原体检测方法第2部分:非直接DNA染色检验法(Mycoplasma detection methods -- Part 2: Indirect DNA staining assay)5 JIS K 7363-1999 塑料风化试验中辐射的仪器测定通用指南和规范基础(Plastics -- Instrumental determination of radiant exposure in weathering tests -- General guidance and basic test method)6 JIS K 7372- 塑料氯乙烯乙酸基乙烯酯共聚物乙酸基乙烯酯的测定(Plastics -- Vinyl chloride-vinyl acetate copolymers -- Determination of vinyl acetate)7 JIS W 0113 ERRATUM 1- 飞行动力学概念、量及符号第3部分:力、力矩及其系数的导数(Flight dynamics -- Concepts quantities and symbols -- Part 3: Derivatives of forces moments and their coefficients (Erratum 1)) 8 JIS C 3342 ERRATUM 1- 600 V 聚氯乙烯绝缘铠装电缆(勘误 1)(600 V Polyvinyl chloride insulated and sheathed cables (Erratum 1))9 JIS K 5600-5-10-1999 涂料试验方法:第5部分:膜的机械特性第10节:磨损抗性试验(往复试验控制板法)(Testing methods for paints -- Part 5: Mechanical property of film -- Section 10: Abrasion resistance (Reciprocating test panel method))10 JIS K 6304-1994 自行车用内胎(INNER TUBES FOR BICYCLES TYPES)11 JIS T 0601-1-2- 医用电气设备第1部分:安全的一般要求2辅助标准:电磁兼容性试验和要求(Medical electrical equipment -- Part 1: General requirements for safety -- 2 Collateral standard: Electromagnetic compatibility -- Requirements and tests)12 JIS Z 2101-1994 木材试验方法(METHODS OF TEST FOR WOOD)13 JIS K 4133-1995 对氨基萘磺酸钠(Sodium naphthionate)14 JIS K 0603- 免疫球蛋白定量分析方法(Proteins -- Immunoglobulin -- Methods for quantitative analysis)15 JIS K 5646 ERRATUM 1- 漆分树脂内层涂料(勘误1)(Cashew resin undercoats (Erratum 1))16 JIS K7313-1- 塑料聚苯醚(PPE)模塑和挤压材料第1部分:名称与符号系统和规范基础(Plastics -- Polyphenylene ether (PPE) moulding and extrusion materials -- Part 1: Designation system and basis for specifications)17 JIS K 1510-1993 季戊四醇(Pentaerythritol)18 JIS K 1201-4- 工业用碳酸钠第4部分:氯化钠含量的测定改进的伏哈德电位测量法(Sodium carbonate for industrial use -- Part 4: Determination of sodium chloride content -- Modified volhard method potentiometric method)19 JIS R 6211-14- 粘合磨料产品尺寸第14部分:在角度式砂轮机上用清理和去毛刺砂轮(Bonded abrasive products -- Dimensions -- Part 14: Grinding wheels for deburring and fettling/snagging on an angle grinder)20 JIS C 8309-1999 挠性金属管道(Pliable metal conduits)21 JIS K 4822- 爆炸物稳定性试验用试剂(Reagents for stability tests of explosives)22 JIS B 8325- 水池用潜水泵(Submersible motor pumps for sump)23 JIS K 7370- 塑料聚氯乙烯树脂压实视松装密度的测定(Plastics -- PVC Resins -- Determination of compacted apparent bulk density)24 JIS K 7559-1996 通用测辐射胶片(Universal Badge films25 JIS W 7203-1984 飞行器电气系统飞行试验一般要求(Flight testing of electric systems in aircraft general requirements for)26 JIS T 9111-1- 橡胶避孕套第1部分:要求(Rubber condoms -- Part 1: Requirements)27 JIS K 1427-1983 亚硝酸钠(Sodium nitrite)28 JIS A 1129-3- 灰浆和混凝土长度变化的试验方法第3部分:千分表法(Methods of test for length change of mortar and concrete Part 3: Method with dial gague)29 JIS K 4180-1995 邻-硝基茴香醚(ortho-Nitroanisole)30 JIS D 1036- 摩托车和机动自行车用惯性滑行法测定框架测力计上的道路荷载(Motorcycles and mopeds -- Road load setting on chassis dynamometer by coastdown method)31 JIS K 1321-1994 硫酸(Sulfuric acid)32 JIS K 5600-8-2-1999 涂料试验方法:第8部分:涂料涂层变坏的评价第2节:起泡程度标识(Testing methods for paints -- Part 8: Evaluation of degradation of paint coatings -- Section 2: Designation of degree of blistering)33 JIS W 0125-3- 航空流体系统词汇第3部分:与温度有关的术语和定义(Aerospace -- Fluid systems -- Vocabulary -- Part 3: General terms and definitions relating to temperature)34 JIS K 7111-1996 塑料摆式冲击强度测定(Plastics -- Determination of charpy impact strength)35 JIS K 7243-1996 环氧树脂中无机氯测定(Determination of inorganic chlorine in epoxide resins)36 JIS C 9335-2-15- 家用和类似用途电器的安全第2-15部分:加热液体用装置的特殊要求(Household and similar electrical appliances -- Safety -- Part 2-15: Particular requirements for appliances for heating liquids) 37 JIS B 7951-1998 大气中一氧化碳的连续分析仪(Continuous analyzer for carbon monoxide in ambient air)38 JIS K 6751-1-1999 邻苯二甲酸脂的试验方法第1部分:总则(Testing methods for phthalic esters -- Part 1: General)39 JIS K 1200-9-1- 工业用氢氧化钠第9部分:镁含量的测定第1节:火焰原子吸收分光光度法(Sodium hydroxide for industrial use -- Part 9: Determination of magnesium content -- Section 1: Flame atomic absorption spectrometry)40 JIS K 4142-1995 氯苯胺类(邻氯苯胺、对氯苯胺)(Chloroanilines (ortho-Chloroanilinepara-Chloroaniline))41 JIS A 1480- 建筑物用隔热材料和产品测定标称和设计热值的方法(Thermal insulating materials and products for buildings -- Procedures for determining declared and design thermal values)42 JIS Z 2244- 维氏硬度试验试验方法(Vickers hardness test -- Test method)43 JIS B 3700-202-1998 工业自动化系统和集成电路产品数据表示和交换第202部分:应用协议:联合制图(Industrial automation systems and integration -- Product data representation and exchange -- Part 202: Application protocol: Associative draughting)44 JIS L 6312-1999 提花织造用带综眼丝综(Twin wire healds with inset mail for jacquard weaving)45 JIS K 7220-1999 泡沫塑料硬质材料的压缩试验(Cellular plastics -- Compression test for rigid materials)46 JIS B 8372-1- 液压动力压缩空气压力调节器和过滤器调节器第1部分:包括用户和产品制作要求资料中的主要特征(Pneumatic fluid power -- Compressed air pressure regulators and filter-regulators -- Part 1: Main characteristics to be included in literature from suppliers and product-making requirements)47 JIS Z 2285- 金属材料线性热膨胀系数的测量方法(Measuring method of coefficient of linear thermal expansion of metallic materials)48 JIS H 1611- 钛及钛合金化学分析方法通则(Titanium and titaniumalloys -- General rules for chemical analysis)49 JIS B 3700-224- 工业自动化系统和集成产品数据的表示和交换第224部分:应用协议:利用机械加工特性的加工计划用机械产品定(Industrial automation systems and integration -- Product data representation and exchange -- Part 224: Application protocol: Mechanical product definition for process planning using machining features)50 JIS Z 9103-1995 安全色总规范(SAFETY COLOURS - GENERAL SPECIFICATION)51 JIS A1 101-1998 混凝土塌落度的试验方法(Method of test for slump of concrete)52 JIS K 5401-1969 用铅笔划痕的涂膜试验机(Pencil scratch tester for coated film)53 JIS Z2332-1993 压力变化测量漏泄用试验方法(Test method for leaks using the pressure change measurement)54 JIS L 4406- 瓷砖铺面(Tile carpet)55 JIS A 5364 ERRATUM 1- 预制混凝土制品材料和制品方法的通用规则(Precast concrete products -- General rules of materials and product methods (Erratum 1))56 JIS B 7118-1994 照相机用三脚架(Tripods for cameras)57 JIS A1144- 新浇混凝土水中氯化物浓度的试验方法(Methods of test for chloride concentration in water of fresh concrete)58 JIS K 1560-1994 1112-四氟甲烷(HFC-134a) (1 1 1 2-Tetrafluoroethane (HFC-134a))59 JIS W 7007-1991 飞行器地面供给电源一般要求(Aircraft -- Ground support electrical supplies -- General requirements)60 JIS S3018- 燃油洗浴用锅炉(Oil burning bath boilers)61 JIS C 1603-1983 指示式电阻温度计(Indicating resistance thermometers)62 JIS B0671-3- 产品几何量技术规范(GPS)表面结构:轮廓法有分层功能特性的表面第3部分:利用材料概率曲线表征高度(Geometrical Product Specifications (GPS) -- Surface texture: Profile method; Surfaces having stratified functional properties -- Part 3: Height characterization using the material probability curve)63 JIS B 8238-1994 液化石油气用压力调节器(Pressure regulators for liquefied petroleum gas)64 JIS T2617-1980 眼科剪刀(Eye scissors)65 JIS K1200-8-1- 工业用氢氧化钠第8部分:钙含量的测定第1节:火焰原子吸收分光光度法(Sodium hydroxide for industrial use -- Part 8: Determination of calcium content -- Section 1: Flame atomic absorption spectrometry)66 JIS Z 6016- 纸本文献及缩微文献的的电子成像过程(Electronic imaging process of paper documents and microfilmed documents)67 JIS W2924- 航空航天液压液的清洁度分类(Aerospace -- Cleanliness classification for hydraulic fluids)68 JIS C1901-1987 可编程测量仪器用接口系统(An interface system for programmable measuring instruments)69 JIS A7801-1994 防火用水泥砂浆的粉刷方法(Method of plastering of cement mortar for fire protection)70 JIS A9511- 预制泡沫塑料保温材料(Preformed cellular plastics thermal insulation materials)71 JIS K5101-5-3- 颜料试验方法第5部分:分散特性的评估方法第3节:光泽度改变的评估(Test methods for pigments -- Part 5: Methods of assessment of dispersion characteristics -- Section 3: Assessment from the change in gloss)72 JIS R 1801- 用FTIR测量红外线加热器用陶瓷辐射材料频谱发射率的方法(Method of measuring spectral emissivity of ceramic radiating materials for infrared heaters by using FTIR)73 JIS A 1419-2- 声学建筑物和建筑元件内声音隔绝的比率第2部分:楼板冲击声音隔绝(Acoustics -- Rating of sound insulation in buildings and of building elements -- Part 2: Floor impact sound insulation)74 JIS Z 2286- 金属材料高温旋转弯曲疲劳试验方法(Method for high temperature rotating bending fatigue testing of metallic materials) 75 JIS B 8280- 非圆形横截面的压力容器(Pressure vessels of noncircular cross section)76 JIS B 7097-1986 摄影机镜头的ISO颜色组成指数(ISO/CCI)的测定(Determination of ISO colour contribution index (ISO/CCI) of camera lenses)77 JIS C 0364-5-551-1999 建筑物的电气设施第5部分:电气设备的安装和选择第55章:其它设备第551节:低电压发电装置(Electrical installations of buildings Part 5: Selection and erection of electrical equipment Chapter 55: Other equipment Section 551: Low-voltage generating sets)78 JIS C 0364-5-52 AMD 1- 建筑物的电气设施第5部分:电气设备的选择和安装第52章:布线系统(修改件1)(Electrical installations of buildings Part 5: Selection and erection of electrical equipment Chapter 52: Wiring systems (Amendment 1))79 JIS C 1612- 辐射温度计的试验方法(Test methods for radiation thermometers)80 JIS C 1210-1979 功率表通则(General rules for electricity meters)81 JIS X 3009- 信息技术程序设计语言Ada(Information technology -- Programming languages -- Ada)82 JIS B 3502-1997 程序控制器设备要求和试验(Programmable controllers -- Equipment requirements and tests)。
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KAIMINGFIRST ENGLISH BOOK(For Junior Middle Schools)ByLIN YUTANG A.M.(HARVARD), DR.PHIL(LEIPZIG)Sometime Professor of English PhilologyPeking National UniversityREVISEDIn collaboration withMRS.H.M.DAVIESSenior Assistant, Department ofPhonetics, University College,London UniversityTHE KAIMING BOOK CO.GENERAL PRINCIPLES OF TEACHING ENGLISH1. In the beginning of learning English,use imitation and repetition as the surest ways of getting results.2. Fight shy of the abstract, theoretical and analytical method of approach(like grammar,translation and phonetic theory).3. MAKE the students learn whole sentences, and not individual words. Let them absorb the sentences as a whole,with their grammatical structure, pronunciation, intonation and all.4. Create an atomosphere wherein the students would feel free to try and talk, and not be afraid of making mistakes. If the fear of low marks is an actual hindrance to their freedom of talking, do away with the marks during the practice.5. It is not sufficient that a student should learn the meaning of individual words; it is much more important that he should learn to use a word at least in one way correctly, Emphasize its proper use in a correct sentence, rather than its abstract meaning.6. Memory work is just as impiortant in learning a foreign language as in learning ancient Chinese.7. Encourage talking, All students have a natural desire to talk. Arouse their interest in the subject talk about. When interest has been aroused, and the students feel they want to say something, help them to say it, even if it involves words not in the lessons. Words thus learnt when there is a living need for them will be remembered more vividly.8. Teaching living English as it is actually spoken by educated Englishmen.TO THE TEACHER1. Length of Lessons. Allow two days for each of the first lessons, one day for careful reading, imination, explanation, and drill on pronunciation of words, and the other day for questions, oral work, more reading aloud and more drill on pronunciation,spelling and spelling and written work. Take one or two days for the latter lessons, according to the needs and ability of the class. Do thorough work, rather than hurry through the book. Generally, the reading lessons will take two days, while the language lessons may require only day.2. Teaching the New Lesson. Read the lesson over clearly, and insist on the students reading aloud after the teacher. Utilize imitation to a large extent. Ask some or all students to read individually, correcting individual mistakes. Then also ask the class to read together, in order to give every oneas much opportunity for practice as possible during the hour.3. Home Assignment. Never assign an entirely new lesson for the students to prepare at home. Assign a few sentences of the lesson already gone over to be copied at home. Assign one or two sentences to be memoried and recited in the next class.4. Repetition. In the second day’s work, give plenty of chance for the students to speak. Repeat the same question with different students. Count on repetition to insure the students’ mastery of the lesson.5. Real Oral Work. Make this part of the oral work as real as possible, following of course only the models given in the book. The language lessons are especially constructed to make such a oral discussion with certain limits possible, most of the material being closely related to the students’ immediate surroundings and immediate needs for expression,(age, action, whereabouts, number, comparison, the lesson, the classroom, etc.). In this sense, the exercise in this bool are merely suggestive. Vary these according to the real situation of the day in order to make the students feel that they are actuallysaying something, instead of merely repeating the book.6. Supervised Speaking. Insist on complete sentencens for answers as a general rule, and not detached words and phrases merely. It is impossible to expect too much independence from the students at this stage. Help the students in their efforts to express themselves, rather than wait to detect their mistakes. If mistakes are made, insist on the students saying the sentences again and again, until they succeed in producing a correct and smoth sentence. Make other students repeat the same sentences.7. Supervised Writing. Have the students do some writing in class, the teachers correcting faulty position of the hand, and giving useful comment and assistance in general.8. Translation. As variation only, suggest sentences in Chinese for the students to express in English. Question given in English are by far to be preferred to translation, as they give additional chance for the students to hear English and think in English. When translation required, ask for translation of whole complete sentences rather than translation of words, and certainly allow no transliteration. The value of translation consists in showing how differently the same idea may be handled in two languages.9. Review. Have continual reviews every four or five lessons. The best way of reviewing is to dictate detached sentences from the old lessons, taken away from their old context. Dictate not only the immediately foregoing lessons, but also those of the past weeks or months.10. Dictation. Have very frequent dictation, for the object of testing the students’ understanding, practising their hearing of English, and testing accuracy of spelling. Detached sentences are to be prefered.11. Memory Work. Use required memory work as the best means of drilling onpronunciation and instilling correct models of sentences into the students’ minds. Have one memory sentence for every week to be recited in class. Once in a while, make the students recite a whole lesson or half a lesson. The rhymes in this book are especially adapted to this purpose. Though the repetition, they make excellent pronunciation drills for the students. Insist on a perfect, or almost perfect, pronunciation of the memory work.12. Pronunciation Marks. Gradually teach the students the different values of “long” and “short” a’s, etc. Ask the students what sound a letter has, as the “a’s” and “o” in “season,” “oo” in “good,” “ar” and “e” in “garden,” “o” in “second,” etc. Constantly refer to the table on pp. 16-17.13. Phonic Drill. Have occasional phonic drills as suggested in the lessons. Use largely the “look and say” method, avoiding technical terms.14. Spelling Contests. Once in three or four weeks, have a spelling contest. Divide the class into two groups, each group giving in turn one word for the other group to spell.15. Substitution Exercises. Use, whenever possible, substitution exercises as suggested in lessons 15,22,84. Suggest the substitute expressions in Chinese, if necessary.16. Grammar. Teach grammar inductively as the correct and accurate observation of the forms and usage of words. Drill on such forms and usage of words, multiplying examples, without using grammatical terminology as yet in this book.学习英文要诀一、学英文时须学全句,勿专念单字。
国际象棋常用术语归纳及解释国际象棋(International Chess),又称欧洲象棋或西洋棋(港澳台地区多采用此说法),是一种二人对弈的战略棋盘游戏。
下面店铺给你介绍国际象棋常用术语归纳及解释,欢迎阅读。
国际象棋常用术语归纳及解释gui积极的(Active):相对于对方的走法,更倾向于进去和战术的走法。
也指更进去的一步棋或局面。
优势(Advantage):通常来自物质、时间、空间,以及兵型上的,局面上客观存在的领先。
代数记谱法(Algebraic notation):有时指国际象棋记法或简单地记法。
表示国际象棋棋步的一种方式。
大概有许多种记录国际象棋着法的方式就象有多种语言一样。
但是,代数记法成为了国际标准。
根本上讲,就是每个格子被给于一个字母和一个数字。
从白方的方向看,由左到右竖线用字母表示为a 、b 、c 、d 、e 、f、g和h,从白方到黑方的横线则为1, 2,3,4,5,6, 7和8。
这样,白方的左下角的格子就叫a1,而右上角就是h8。
当棋子从一个格走到另一个格,代数记谱法使您辨认出行动的棋子和所到的格子。
例如,如果车从a1格走到a8格,您写成Ra8。
对于兵的走动,您只写兵到达的格子;例如,e4。
王翼易位记作0-0。
后翼易位记作0-0-0。
分析(Analysis):基于一个特定局面的连续着法的演算。
比赛中,您不被允许移动棋子来分析而必须在您的头里做所有的演算。
当比赛结束了,刚下完棋的对手共同地分析这个对局,走动棋子来努力找出最解着法。
注释(Annotation):关于局面或对局的书面评论。
评论可能采取记叙文,记谱法,或两者组合的形式。
攻击(Attack):在棋盘的某一个区域里开始的一次进取的行动,或是吃子、吃兵的威胁。
叠(Battery):在一个竖线上放两个车或在同一个斜线上放一个象、一个后。
冒险家(Berserker):只用一两个棋子进攻的疯狂走法。
以自己疯狂战斗的古老的斯堪的纳维亚战士命名的,并且后来被他们的对手用尊敬的战略或人身的危险所改变。