ISO 10993-5-2009 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)
ISO 10993-5:2009(E)中英文版
国际标准
Third edition
第3版
2009-06-01
Biological evaluation of medical devices —Part 5:
Tests for in vitro cytotoxicity
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)
2025年06月翻译
参考版本号
ISO 10993-5:2009(E)
PAGE:1 CISO2024-Allrightsreserved
ISO 10993-5:2009(E)中英文版
目 录
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. Sample and control preparation 样品和对照品制备............................................................................................................................. 8
4.1. General 总 则....................................................................................................................................................................................................8
4.2. Preparation of liquid extracts of material 材料浸提液的制备 .................................................................................................. 8
4.3. Preparation of material for direct -contact tests 直接接触试验材料的制备............................................................................11
4.4. Preparation of controls 对照品制备....................................................................................................................................................12
5. Cell lines 细胞系............................................................................................................................................................................................... 13
6. Culture medium 培养基 ................................................................................................................................................................................. 14
7. Preparation of cell stock culture 贮存培养细胞制备 ............................................................................................................................. 14
8. Test procedures 试验步聚............................................................................................................................................................................... 14
8.1. Number of replicates 平行样数........................................................................................................................................................... 14
8.2. Test on extracts 浸提液试验............................................................................................................................................................... 14
8.3. Test by direct contact 直接接触试验................................................................................................................................................. 16
8.4. Test by indirect contact 间接接触试验............................................................................................................................................. 17
8.5. Determination of cytotoxicity 细胞毒性的测定............................................................................................................................. 19
9. Test report 试验报告 ........................................................................................................................................................................................21
10. Assessment of results 结果评定............................................................................................................................................................. 21
AnnexA(informative) Neutral red uptake (NRU) cytotoxicity test
附 录A(资料性)中性红摄取(NRU )细胞毒性试验性 ........................................................................................................................................ 23
Annex B (informative) Colony formation cytotoxicity test
附 录B(资料性)集落形成细胞毒性试验 ........................................................................................................................................................... 3
AnnexC(informative) MTT cytotoxicity test
附录B(资料性)MTT 细胞毒性试验 ..................................................................................................................................................................... 40
Annex D (informative ) XTT cytotoxicity test
附录D(资料性)XTT 细胞毒性试验 .................................................................................................................................................................... 47
Bibliography 参考文献 ........................................................................................................................................................................................51
PAGE:2 CISO2024- Allrightsreserved
ISO 10993-5:2009(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 thee
right to be represented on that committee.International organizations,governmental and non-governmental,in liaison
with ISO,also take part in the work.ISO collaborates closely with the International Electrotechnical Commission(IEC)on
all matters of electrotechnical standardization.
ISO(国际标准化组织)是国家标准机构(ISO成员机构)的全球联盟。制定国际标准的工作通常是通过ISO技术委员会进行的。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派代表参加该委员会。与ISO 有联系的政府和非政府国际组织也参与这项工作。ISO
与国际电工委员会(IEC)在所有电工标准化问题上密切合作。
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,Part 2.
The main task of technical committees is to prepare International Standards.Draft International Standards adopted by
the technical committees are circulated to the member bodies for voting.Publication as an International Standard
requires approval by at least 75%of the member bodies casting a vote.
国际标准是根据ISO/IEC指令第2部分中给出的规则起草的。
技术委员会的主要任务是制定国际标准。技术委员会所采用的国际标准草案被分发给成员机构进行表决。作为国际标准出版需要至少
75%的成员投票批准。
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.ISO
shall not be held responsible for identifying any or all such patent rights.
请注意，本文件中的某些内容可能是专利权的主题。ISO 不负责识别任何或所有此类专利权。
ISO 10993-5 was prepared by Technical Committee ISO/TC 194,Biological evaluation of medical devices.
ISO 10993-5是由技术委员会ISO/TC 194,医疗器械的生物学评价准备的。
This third edition cancels and replaces the second edition(ISO 10993-5:1999)which has been technically revised.
第三版取消并取代了第二版(ISO 10993-5:1999),第二版已经过技术修订。
ISO 10993 consists of the following parts,under the general title Biological evaluation of medical devices:
ISO 10993由以下部分组成，总标题为医疗器械的生物学评价：
-Part 1:Evaluation and testing within a risk management process
-第1部分：风险管理过程中的评估和测试
-Part 2:Animal welfare requirements
-第2部分：动物福利要求
-Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
-第3部分：遗传毒性、致癌性和生殖毒性试验
-Part 4:Selection of tests for interactions with blood
-第4部分：血液相互作用试验的选择
-Part 5:Tests for in vitro cytotoxicity
-第5部分：体外细胞毒性试验
-Part 6:Tests for local effects after implantation
-第6部分：植入后局部效应的测试
-Part 7:Ethylene oxide sterilization residuals
-第7部分：环氧乙烷灭菌残留物
-Part 9:Framework for identification and quantification of potential degradation products
-第9部分：潜在降解产物的识别和量化框架
PAGE:3 CISO2024-Allrightsreserved
摘要：
展开>>
收起<<
ISO10993-5:2009(E)中英文版国际标准Thirdedition第3版2009-06-01Biologicalevaluationofmedicaldevices—Part5:Testsforinvitrocytotoxicity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)2025年06月翻译参考版本号ISO10993-5:2009(E)PAGE:1CISO2024-AllrightsreservedISO10993-5:2009(E)中英文版目录Foreword前言....................................................
声明：如果您的权利被侵害，请联系我们的进行举报。
相关推荐
-
GB∕T 16886.12-2023 医疗器械生物学评价 第12部分：样品制备与参照材料VIP免费
2024-04-14 181 -
GB∕T 25915.2-2021 洁净室及相关受控环境 第2部分：洁净室空气粒子浓度的监测
2024-04-17 999+ -
GB∕T 25915.3-2024洁净室及相关受控环境 第3部分：检测方法VIP免费
2024-08-09 56 -
GB∕T 16886.1-2025医疗器械生物学评价 第1部分 风险管理过程中生物学安全性评价的要求和通用原则（草案稿）VIP免费
2025-09-02 335 -
GB∕T 191-2025 包装储运图示标志（征求意见稿）VIP免费
2025-09-29 992 -
GB∕T 19000-2016 质量管理体系 基础和术语（高清）VIP免费
2025-10-27 283 -
GB∕T 16292-2025 医药工业洁净室（区）悬浮粒子的测试方法VIP免费
2025-10-29 470 -
GB∕T 16293-2025 医药工业洁净室（区）浮游菌的测试方法VIP免费
2025-10-30 301 -
GB∕T 16292《医药工业洁净室（区）悬浮粒子的测试方法》2010版和2025版对比分析（逐条对比）VIP免费
2025-10-30 121 -
GB/T 16294-2025 医药工业洁净室（区）沉降菌的测试方法VIP免费
2025-11-05 215
作者： 51zlzl
分类：法规规范
价格：150质量币
属性：51 页
大小：688.31KB
格式：PDF
时间：2025-11-20
