ISO 10993-3-2014 医疗器械生物学评价第3部分：遗传毒性、致癌性和生殖毒性试验(中英文版)

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ISO 10993-3:2014(E) 中英文版

INTERNATIONAL

STANDARD

国际标准

Third edition

第3版

2014-10-01

Biologicalevaluationof medicaldevices —

Part3:Testsforgenotoxicity,

carcinogenicityandreproductivetoxicity

医疗器械生物学评价

第3部分：遗传毒性、致癌性和

生殖毒性试验

(中英文版)

2024年03月翻译

Reference number

ISO 10993-3:2014(E)

PAGE:1 CISO2014-Allrightsreserved

ISO 10993-3:2014(E) 中英文版

Foreword 前言......................................................................................................................................................................................4

Introduction 介绍...............................................................................................................................................................................

1 .Scope 范围 ................................................................................................................................................................................... 10

2. Normative references 规范性引用文件............................................................................................................................... 10

3 .Terms and definitions 术语及定义...................................................................................................................................... 1

4 Requirements for test strategies 测试策略要求.............................................................................................................13

4.1 General 总则........................................................................................................................................................................... 13

4.2 Additional requirements for carcinogenicity testing 致癌性测试的附加要求...................................................... 14

4.3 Additional requirements for reproductive toxicity testing 生殖毒性试验的附加要求......................................15

5 Genotoxicity tests 遗传毒性试验....................................................................................................................................... 15

5.1 General 总则........................................................................................................................................................................... 15

5.2 Test strategy 测试策略..................................................................................................................................................... 15

5.3 Sample preparation 样品制备....................................................................................................................................... 20

6 Carcinogenicity tests 致癌性试验....................................................................................................................................... 21

6.1 General 总则.......................................................................................................................................................................... 21

6.2 Evaluation strategy 评估策略.......................................................................................................................................... 2

6.3 Sample preparation 样品制备....................................................................................................................................... 23

6.4 Test methods 试验方法 ................................................................................................................................................... 24

7 Reproductive and developmental toxicity tests 生殖和发育毒性试验................................................................. 26

7.1 General 总则...........................................................................................................................................................................26

7.2 Test strategy 测试策略....................................................................................................................................................... 26

7.3 Sample preparation 样品制备....................................................................................................................................... 27

7.4 Test methods 试验方法......................................................................................................................................................28

8 Test report 测试报告...................................................................................................................................................................29

Annex A (informative ) Guidance on selecting an appropriate sample preparation procedure in genotoxicity

testing

附录 A( 资料性附录 ) 遗传毒性测试中选择适当样品制备程序的指南 ........................................................................... 30

Annex B(informative ) Flowchart for follow -up evaluation

附录B( 资料性附录 ) 后续评估流程图 ....................................................................................................................................... 4

Annex C ( informative ) Rationale of test systems

附录C(资料性附录)测试系统的基本原理............................................................................................................................... 45

Annex D (informative ) Cell transformation test systems

附录D(资料性附录)细胞转化试验系统................................................................................................................................... 48

PAGE:2 CISO2014-Allrightsreserved

ISO 10993-3:2014(E) 中英文版

Annex E (normative ) Considerations for carcinogenicity studies performed as implantation studies

附录E(规范性附录)作为植入研究进行致癌性研究的注意事项 .......................................................................................... 50

Annex F (informative ) In vitro tests for embryo toxicity

附录 F(资料性附录)胚胎毒性体外试验 ......................................................................................................................................52

Bibliography 参考文献 ..................................................................................................................................................................... 54

PAGE:3 CISO2014-Allrightsreserved

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标签： #医疗器械 #ISO #生物学评价

摘要：

ISO10993-3:2014(E)中英文版INTERNATIONALSTANDARD国际标准Thirdedition第3版2014-10-01Biologicalevaluationofmedicaldevices—Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity医疗器械生物学评价第3部分：遗传毒性、致癌性和生殖毒性试验(中英文版)2024年03月翻译ReferencenumberISO10993-3:2014(E)PAGE:1CISO2014-AllrightsreservedISO10993-3:2014(...

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ISO 10993-3-2014 医疗器械生物学评价第3部分：遗传毒性、致癌性和生殖毒性试验(中英文版)

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