ISO 10993-4-2017 医疗器械生物学评价第4部分与血液相互作用试验选择(中英文版)

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ISO 10993-4:2017(E)中英文版

国际标准

Third edition

第3版

2017-04

Biological evaluation of medical devices —Part 4:

Selection of tests for interactions with blood

医疗器械生物学评价第4部分：

与血液相互作用试验选择

(中英文版)

2024年05月翻译

参考版本号

ISO 10993-4-2:2017(E)

PAGE:1 CISO2019-Allrightsreserved

ISO 10993-4:2017(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....................................................................................................................................................... 6

4 Abbreviated terms 缩略语........................................................................................................................................................................... 11

5 Types of devices in contact with blood (as categorized in ISO 10993-1)

与血液接触器械的类型(按 ISO 10993- 1 分类)....................................................................................................................................... 12

5.1 Non -blood -contact devices 非血液接触器械.............................................................................................................................12

5.2 External communicating devices 外部接入器械.....................................................................................................................12

5.2.1 General 总则.......................................................................................................................................................................................... 12

5.2.2 External communicating devices that serve as an indirect blood path 作为间接血路的外部接入器械...........13

5.2.3 External communicating devices directly contacting circulating blood

与循环血液直接接触的外部接入器械 ......................................................................................................................................................... 13

5.3 Implant devices 植入器械...................................................................................................................................................................14

6 Characterization of blood interactions 血液相互作用特性......................................................................................................... 14

6.1 General requirements 总体要求....................................................................................................................................................... 14

6.2 Categories of tests and blood interactions 试验类别与血液相互作用............................................................................... 20

6.2.1 Recommended tests for interactions of devices with blood 推荐的器械与血液相互作用试验.............. 20

6.2.2 Non -contact devices 非接触器械.............................................................................................................................................. 2

6.2.3 External communicating devices and implant devices 外部接入器械和植入器械..............................................2

6.2.4 Limitations 局限性........................................................................................................................................................................... 2

6.3 Types of tests 试验类型.......................................................................................................................................................................... 23

6.3.1 In vitro tests 体外试验.................................................................................................................................................................. 23

6.3.2 Ex vivo tests 半体内试验............................................................................................................................................................... 23

6.3.3 In vivo tests 体内试验................................................................................................................................................................... 24

Annex A (informative ) Preclinical evaluation of cardiovascular devices and prostheses

附录 A(资料性)心血管器械和假体的临床前评价..........................................................................................................................................26

Annex B (informative ) Recommended laboratory tests — Principles , scientific basis and interpretation

附录 B(资料性)推荐的实验室试验：原则、科学依据和说明 ....................................................................................................................... 34

Annex C (informative ) Thrombosis — Methods for in vivo testing

附录 C(资料性)血栓—体内试验方法 .............................................................................................................................................................

Annex D (informative ) Haematology / haemolysis — Methods for testing — Evaluation of haemolytic properties of medical

devices and medical device materials

附录 D(资料性)血液学/溶血一试验方法—医疗器械和医疗器械材料的溶血性能评价......................................................................... 58

Annex E (informative ) Complement — Methods for testing 附录 E(资料性)补体一试验方法....................................... 68

Annex F (informative ) Less common laboratory tests 附录 F(资料性)较不常见的实验室试验........................................... 73

Annex G (informative ) Tests which are not recommended 附录 G(资料性)不推荐的试验.................................................. 78

Bibliography 参考文献 ..........................................................................................................................................................................................81

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ISO 10993-4:2017(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)是由国家标准机构(ISO 成员机构)组成的全球联盟。编制国际标准的工作通常通过ISO技术委员会进行。

对已设立技术委员会的主题感兴趣的每个成员机构都有权派代表参加该委员会。与ISO保持联系的政府和非政府国际组织也参与了这

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) 就电工标准化的所有事宜密切合作。

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及其进一步维护的程序。应特别注意不同类型ISO文件所需的不同批准标准。本文

件根据ISO/IEC指令第2部分的编辑规则起草(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要素可能是专利权的主体。ISO 不负责识别任何或所有此类专利权。文件编制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专利声明清单中(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均为为方便用户而提供的信息，不构成背书。

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、与合格评定有关的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，请参见以下网址：www iso .org/iso/foreword .html。

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

本文件由ISO/TC194 医疗器械生物与临床评价技术委员会编制。

This third edition cancels and replaces the second edition (ISO 10993-4:2002),which has been technically revised.

第三版取消并取代了第二版(ISO 10993-4:2002),第二版已经过技术修订。

It also incorporates the Amendment ISO 10993-4:2002/Amd 1:2006.

它还包含了ISO 10993-4:2002/Amd 1:2006修正案。

The following changes were made:

进行了以下更改：

a)some definitions have been revised and new definitions have been added;

a) 修订了部分定义，增加了新的定义；

PAGE:3 CISO2019-Allrightsreserved

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标签： #医疗器械 #ISO #生物学评价

摘要：

ISO10993-4:2017(E)中英文版国际标准Thirdedition第3版2017-04Biologicalevaluationofmedicaldevices—Part4:Selectionoftestsforinteractionswithblood医疗器械生物学评价第4部分：与血液相互作用试验选择(中英文版)2024年05月翻译参考版本号ISO10993-4-2:2017(E)PAGE:1CISO2019-AllrightsreservedISO10993-4:2017(E)中英文版目录Foreword前言........................................

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