ISO 10993-12-2021 医疗器械生物学评价第12部分：样品制备与参照材料（中英文）

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ISO 10993-12:2021(E)中英文版

INTERNATIONAL

STANDARD

国际标准

Fifth edition

第5版

2021-01

Biologicalevaluationof medicaldevices —

Part12:Samplepreparationandreference

materials

医疗器械生物学评价

第12部分：样品制备与参照材料

(中英文版)

2024年03月翻译

Reference number

ISO 10993-12:2021(E)

PAGE:1 CISO2019-Allrightsreserved

ISO 10993-12:2021(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 General requirements 总体要求............................................................................................................................................. 11

5 Reference materials ( RMs )参考材料(RM) .................................................................................................................. 12

5.1 General 概述 .......................................................................................................................................................................... 12

5.2 Certification of RMs for biological safety testing 生物安全性试验用 RM 的认证......................................... 12

6 Use of RMs as experimental controls RM 作为试验对照的应用...........................................................................13

7 Test sample selection 试样选择.......................................................................................................................................... 13

8 Test sample and RM preparation 试样和RM 制备................................................................................................... 14

9 Selection of representative portions from a medical device 器械代表性部分的选择 ................... 15

10 Preparation of extracts of samples 样品浸提液制备.................................................................................................. 16

10.1 General 总体要求 ................................................................................................................................................................. 16

10.2 Containers for extraction 浸提容器........................................................................................................................... 16

10.3 Extraction conditions and methods 浸提条件和方法........................................................................................... 16

10.4 Extraction conditions for materials that polymerize in situ 原位聚合材料的浸提条件........................... 23

11 Record 记示............................................................................................................................................................................... 23

Annex A (informative ) Experimental controls 附录A(资料性)实验对照 ................................................................. 25

Annex B(informative ) General principles on , and practices of, test sample preparation and sample selection.

附录 B(资料性)试验样品制备和样品选择的基本原则与规范 .................................................................................................. 27

Annex C (informative ) Principles of test sample extraction 附录C(资料性)试验样品浸提原则..................................... 29

Annex D (informative ) Exhaustive extraction of polymeric materials for biological evaluation

附录 D(资料性)聚合材料生物学评价的极限浸提..................................................................................................................... 33

Bibliography 参考文献 ...................................................................................................................................................................... 37

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I S O 1 0 9 9 3 - 1 2 : 2 0 2 1 ( 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。特别是，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 allsuch 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 of 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 www .iso .org/iso/foreword.html.

关于标准的自愿性质的解释，与合格评定相关的ISO特定术语和表达的含义，以及关于ISO遵守世界贸易组织 (WTO) 技

术性贸易壁垒(TBT) 原则的信息，请参见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).

本文件由ISO/TC 194医疗器械生物与临床评估技术委员会与欧洲标准化委员会CEN/TC 206医疗器械生物和临床评估技术

PAGE:3 CISO2019-Allrightsreserved

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标签： #医疗器械 #ISO #生物学评价

摘要：

ISO10993-12:2021(E)中英文版INTERNATIONALSTANDARD国际标准Fifthedition第5版2021-01Biologicalevaluationofmedicaldevices—Part12:Samplepreparationandreferencematerials医疗器械生物学评价第12部分：样品制备与参照材料(中英文版)2024年03月翻译ReferencenumberISO10993-12:2021(E)PAGE:1CISO2019-AllrightsreservedISO10993-12:2021(E)中英文版目录Foreword前言..........

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ISO 10993-12-2021 医疗器械生物学评价第12部分：样品制备与参照材料（中英文）

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