ISO 10993-17-2023医疗器械生物学评价-第17部分：医疗器械成分的毒理学风险评估(中英文版）

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ISO 10993-17:2023(E)中英文版

INTERNATIONAL

STANDARD

国际标准

Second edition

第2版

2023-09

Biological evaluation of medical devices —

Part 17:Toxicological risk assessment of

medical device constituents

医疗器械生物学评价-第17部分：

医疗器械成分的毒理学风险评估

(中英文版)

2024年05月翻译

Reference number

ISO 10993-17:2023(E)

PAGE:1 CISO2019-Allrightsreserved

ISO 10993-17:2023(E)中英文版

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

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

1 .Scope 范围................................................................................................................................................................................................ 9

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

3 .Terms and definitions 术语及定义 ............................................................................................................................................10

4 Abbreviated terms and symbols 缩写术语和符号.................................................................................................................... 21

5 Toxicological risk assessment within the biological evaluation process

生物评价过程中的毒理学风险评估 ........................................................................................................................................................ 21

5.1 General 概述................................................................................................................................................................................... 2

5.1.1 Risk assessment principles 风险评估原则......................................................................................................................2

5.1.2 Hazard identification 危害识别.........................................................................................................................................23

5.1.3 Risk estimation 风险评估....................................................................................................................................................24

5.2 Toxicological risk assessment process 毒理学风险评估流程........................................................................................27

6 Constituent specific toxicological information 成分特异性毒理学信息.............................................................. 30

6.1 General 概述................................................................................................................................................................................. 30

6.2 Identification of hazardous constituents 危险成分的识别..................................................................................... 31

6.2.1 General 概述 ........................................................................................................................................................................... 31

6.2.2 Application of the toxicological screening limit 毒理学筛选限值的应用.............................................. 34

6.2.3 Identification of human carcinogens or suspected human carcinogens

人类致癌物或疑似人类致癌物的鉴定.........................................................................................................................................35

6.2.4 Selection of the point of departure 出发点的选择 .................................................................................................36

7 Tolerable contact level, tolerableintake and threshold of toxicological concern

可耐受接触水平，可耐受摄入量和毒理学关注阈值.......................................................................................................................... 37

7.1 Derivation of TCL and TI TCL和TI的推导........................................................................................................................37

72 Application of Tc TTC的应用............................................................................................................................................. 38

8 Exposure dose estimation 暴露剂量估算....................................................................................................................................39

9 Margin of safety 安全边际 ................................................................................................................................................................41

9.1 General 概述 ................................................................................................................................................................................... 41

9.2 Calculating the margin of safety 计算安全边际 ............................................................................................................. 41

9.2.1 General 概述 ......................................................................................................................................................................... 41

9.2.2 Combining MoS values to address additivity of harm 结合MoS 值来解决危害的可加性............................. 4

10 Toxicological risk acceptance criteria 毒理学风险接受标准.......................................................................................... 45

10.1 General 概述................................................................................................................................................................................. 45

10.2 Further risk analysis or isk evaluation or risk control 进一步的风险分析或风险评估或风险控制.................46

11 Reporting requirements 报告要求.......................................................................................................................................... 47

Annex A (normative) Evaluation of toxicological data quality when selecting a point of departure

PAGE:2 CISO2019-Allrightsreserved

ISO 10993-17:2023( E) 中英文版

附录A(规范性附录)选择出发点时毒理学数据质量的评估....................................................................................................... 48

Annex B( normative ) Derivation of toxicological screening limits

附录B(规范性附录)毒理学筛选限值的推导 ............................................................................................................................... 50

Annex C ( normative ) Derivation of constituent TI or TCLfor select endpoints

附录 C(规范性附录)选定端点的成分TI或TCL的推导 ........................................................................................................... 59

Annex D(informative) Typical assumptions for biologicalparameters

附录 D(资料性附录)生物参数的典型假设............................................................................................................................... 72

Annex E (normative ) Estimation of an exposure dose 附录E(规范性附录)暴露剂量估算.......................................76

Annex F(informative ) Reporting of toxicological risk assessment information

附录F(资料性附录)毒理学风险评估信息报告 ........................................................................................................................... 90

Bibliography 参考文献 ................................................................................................................................................................... 96

PAGE:3 CISO2019-Allrightsreserved

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标签： #医疗器械 #ISO #风险评估

摘要：

ISO10993-17:2023(E)中英文版INTERNATIONALSTANDARD国际标准Secondedition第2版2023-09Biologicalevaluationofmedicaldevices—Part17:Toxicologicalriskassessmentofmedicaldeviceconstituents医疗器械生物学评价-第17部分：医疗器械成分的毒理学风险评估(中英文版)2024年05月翻译ReferencenumberISO10993-17:2023(E)PAGE:1CISO2019-AllrightsreservedISO10993-17:2023(E)...

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ISO 10993-17-2023医疗器械生物学评价-第17部分：医疗器械成分的毒理学风险评估(中英文版）

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