ISO 10993-1-2018 医疗器械的生物评价第1部分：风险管理过程中的评价和测试(中英文版)

51zlzl 2025-11-20 9 994.76KB 73 页 300质量币

侵权投诉

ISO 10993-1:2018(E) 中英文版

INTERNATIONAL

STANDARD

国际标准

Fifth edition

第5版

2018-08

Biological evaluation of medical devices —Part

1:Evaluation and testing within a risk management

process

医疗器械的生物评价第1部分：

风险管理过程中的评价和测试(中英文版)

2024年03月翻译

Reference number

ISO 10993-1:2018(E)

PAGE:1 CISO2018-Allrightsreserved

ISO 10993-1:2018(E) 中英文版

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

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

1. Scope 范围......................................................................................................................................................................................7

2. Normative references 规范性引用文件 ................................................................................................................................. 8

3. Terms and definitions 术语及定义.................................................................................................................................... 9

4. General principles applying to biological evaluation of medical devices 医疗器械生物学评价的一般原则........... 15

5. Categorization of medical devices 医疗器械的分类....................................................................................................... 21

5.1. General 概述....................................................................................................................................................................... 21

5.2. Categorization by nature of body contact 按身体接触性质分类................................................................. 2

5.2.1. Non -contacting medical devices 非接触式医疗器械....................................................................................... 2

5.2.2. Surface -contacting medical devices 表面接触医疗器械............................................................................... 2

5.2.3. Externally communicating medical devices 外部接入医疗器械............................................................... 23

5.2.4. Implant medical devices 植入医疗器械......................................................................................................... 24

5.3. Categorization by duration of contact 按接触时间分类......................................................................................25

5.3.1. Contact duration categories 接触时间分类.............................................................................................25

5.3.2. Transitory -contacting medical devices 瞬时接触医疗器械............................................................... 25

5.3.3. Medical devices with multiple contact duration categories 多种接触时间分类的医疗器械....... 26

6. Biological evaluation process 生物学评价过程.......................................................................................................... 26

6.1. Physical and chemical information for biological risk analysis 生物学风险分析的物理和化学信息........... 26

6.2. Gap analysis and selection of biological endpoints for assessment 差距分析和生物学评估终点的选择...... 27

6.3. Biological testing 生物学测试.......................................................................................................................................28

6.3.1. General 概述............................................................................................................................................................... 28

6.3.2. Testing for evaluation 评估试验....................................................................................................................... 30

7. Interpretation of biological evaluation data and overallbiologicalrisk assessment

生物学评价数据的解释和生物风险的总体评估 ..........................................................................................................................18

Annex A (informative ) Endpoints to be addressed in a biological risk assessment

附件A( 资料性) 生物学风险评定涉及的终点 ....................................................................................................................... 40

Annex B (informative ) Guidance on the conduct of biological evaluation within a risk management process

附录 B(资料性附录)关于在风险管理过程中进行生物学评价的指南.............................................................................45

Annex C (informative ) Suggested procedure for iterature review 附录C(资料性附录)建议的文献审查程序...... 68

Bibliography 参考文献 .................................................................................................................................................................. 71

PAGE:2 CISO2018-Allrightsreserved

ISO 10993-1:2018(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.

关于标准的自愿性质、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(WTO) 技术性贸

易壁垒(TBT) 原则的信息，请参阅以下网址：www .iso .org/iso/foreword .html。

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

medical devices.

PAGE:3 CISO2018-Allrightsreserved

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载

标签： #医疗器械 #ISO #管理

摘要：

ISO10993-1:2018(E)中英文版INTERNATIONALSTANDARD国际标准Fifthedition第5版2018-08Biologicalevaluationofmedicaldevices—Part1:Evaluationandtestingwithinariskmanagementprocess医疗器械的生物评价第1部分：风险管理过程中的评价和测试(中英文版)2024年03月翻译ReferencenumberISO10993-1:2018(E)PAGE:1CISO2018-AllrightsreservedISO10993-1:2018(E)中英文版目录Foreword...

展开>> 收起<<

ISO 10993-1-2018 医疗器械的生物评价第1部分：风险管理过程中的评价和测试(中英文版).pdf

共73页,预览50页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

ISO 10993-1-2018 医疗器械的生物评价第1部分：风险管理过程中的评价和测试(中英文版)

相关推荐

相关内容

热门标签

举报选择: