ISO 10993-2-2022 医疗器械生物学评价—第2部分：动物福利要求(中英文版)

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ISO 10993-2:2022(E)中英文版

INTERNATIONAL

STANDARD

国际标准

Third edition

第3版

2022-11

Biological evaluation of medical devices —

Part 2:Animal welfare requirements

医疗器械生物学评价—

第2部分：动物福利要求

(中英文版)

2025年05月翻译

Reference number

ISO 10993-2:2022(E)

PAGE:1 CISO2022-Allrightsreserved

ISO 10993-2:2022(E)中英文版

Foreword 前言 ............................................................................................................................................................................................. 3

Introduction 介绍........................................................................................................................................................................................5

1 .Scope 范围.................................................................................................................................................................................................6

2. Normative references 规范性引用文件 ...........................................................................................................................................6

3. Terms and definitions 术语及定义........................................................................................................................................... 7

4 Requirements 要求 ............................................................................................................................................................................. 1

4.1 General 总则...................................................................................................................................................................................11

4.2 Justification for animal tests 动物试验的合理性..............................................................................................................12

4.3 Competence of personnel 人员能力..................................................................................................................................... 13

4.4 Planning and performance of animal tests 动物试验计划与实施.............................................................................. 13

4.4.1 General 总则......................................................................................................................................................................... 13

4.4.2 Re- use 动物重复使用.............................................................................................................................................................14

4.5 Test strategy — Sequence of in vitro and in vivo tests .试验策略一体外与体内试验的顺序.......................... 14

4.6 Animal care and accommodation 动物饲养与管理 ..........................................................................................................15

4.6.1 General 总则........................................................................................................................................................................... 16

4.6.2 Restraint 动物固定 ................................................................................................................................................................. 16

4.6.3 Surgical procedures 外科步骤 ..........................................................................................................................................16

4.7 Humane end points 人道终点.................................................................................................................................................16

4.7.1 General 总则............................................................................................................................................................................16

4.7.2 Euthanasia 人道方式处死..................................................................................................................................................... 17

4.8 Study documentation 研究文件 .............................................................................................................................................17

4.9 Validity of test results and mutual acceptance of data 试验结果有效性与数据互认...........................................18

Annex A (informative) Rationale for the development of this document

附录A(资料性附录)本部分编制说明 ..................................................................................................................................................... 19

Annex B(informative ) Further suggestions for replacing , reducing and refining animaltests

附录B(资料性附录)替代、减少和优化动物试验的其他建议 ..............................................................................................................25

Bibliography 参考文献 ........................................................................................................................................................................... 27

PAGE:2 CISO2022-Allrightsreserved

ISO 10993-2:2022(E)中英文版

Foreword

前言

ISO(the International Organization for Standardization)is a worldwide federation of national standards

bodies (ISO member bodies).The work of preparing International Standards is normally carried out through

ISO technical committees.Each member body interested in a subject for which a technical committee has

been established has the right to be represented on that committee.International organizations,

governmental and non-governmental,in liaison with ISO,also take part in the work.

ISO(国际标准化组织)是一个由国家标准机构(ISO 成员机构)组成的世界性联合会。编制国际标准的工作通常通过

ISO技术委员会进行。对已成立技术委员会的主题感兴趣的每个成员机构都有权在该委员会中派代表。与国际标准化组

织联络的政府和非政府国际组织也参加了这项工作。

ISO collaborates closely with the International Electrotechnical Commission (IEC)on all matters of

electrotechnical standardization.

ISO与国际电工委员会(IEC) 在电工技术标准化的所有事项上密切合作。

The procedures used to develop this document and those intended for its further maintenance are described

in the ISO/IEC Directives,Part 1.In particular the different approval criteria needed for the different types of

ISO documents should be noted.This document was drafted in accordance with the editorial rules of the

ISO/IEC Directives,Part 2 (see www.iso.org/directives).

ISO/IEC指令第1部分描述了用于编制本文件的程序以及用于进一步维护的程序。尤其应注意不同类型ISO 文件所需的不

同批准标准。本文件是根据ISO/IEC指令第2部分的编辑规则起草的(见www.iso.org/directives)。

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights.ISO shallnot be held responsible for identifying any or all such patent rights.Details of any

patent rights identified during the development of the document will be in the Introduction and/or on the

ISO list of patent declarations received (see www.iso.org/patents).

请注意，本文件的某些内容可能是专利权的主题。ISO 不承担识别任何或所有此类专利权的责任。在文件开发过程中确

定的任何专利权的详细信息将在引言和/或收到的ISO 专利声明列表中(见www.iso.org/patents)。

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

本文件中使用的任何商品名称都是为了方便用户而提供的信息，不构成完全认可。

For an explanation on the voluntary nature of standards,the meaning of ISO specific terms and expressions

related to conformity assessment,as well as information about ISO's adherence to the World Trade

Organization (WTO)principles in the Technical Barriers to Trade(TBT)see the following URL:

www.iso.org/iso/foreword.html.

关于标准的自愿性、与合格评定相关的ISO 特定术语和表达的含义以及ISO遵守世界贸易组织技术性贸易壁垒原则的信

息，请访问以下网址：http://www.ISO.org/ISO/foreword.html。

This document was prepared by Technical Committee ISO/TC 194 Biological and clinical evaluation of

medical devices,in collaboration with the European Committee for Standardization(CEN)Technical

Committee CEN/TC 206,Biological and clinical evaluation of medical devices,in accordance with the

Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

PAGE:3 CISO2022-Allrightsreserved

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标签： #医疗器械 #ISO #生物学评价

摘要：

ISO10993-2:2022(E)中英文版INTERNATIONALSTANDARD国际标准Thirdedition第3版2022-11Biologicalevaluationofmedicaldevices—Part2:Animalwelfarerequirements医疗器械生物学评价—第2部分：动物福利要求(中英文版)2025年05月翻译ReferencenumberISO10993-2:2022(E)PAGE:1CISO2022-AllrightsreservedISO10993-2:2022(E)中英文版目录Foreword前言..............................

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ISO 10993-2-2022 医疗器械生物学评价—第2部分：动物福利要求(中英文版)

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