ISO 10993-6-2016 医疗器械生物学评价第6部分：植入后局部反应试验(中英文版)

51zlzl 2025-11-20 10 650.97KB 49 页 200质量币

侵权投诉

ISO 10993-6:2016(E) 中英文版

INTERNATIONAL

STANDARD

国际标准

Third edition

第3版

2016-12-01

Biological evaluation of medical devices—Part 6:

Tests for local effects after Implantation

医疗器械生物学评价

第6部分：植入后局部反应试验

(中英文版)

2024年03月翻译

Reference number

ISO 10993-6:2016(E)

PAGE:1 CISO2016-Allrightsreserved

ISO 10993-6:2016(E)中英文版

Foreword 前言 ................................................................................................................................................................................3

1. Scope范围................................................................................................................................................................................ 6

2. Normative references规范性引用文件 .............................................................................................................................. 7

3. Terms and definitions 术语及定义......................................................................................................................................7

4. Common provisions for implantation test methods植入试验方法的通用规定.........................................................

5. Test methods, general aspects试验方法，一般方面................................................................................................ 1

6. Test report 测试报告.........................................................................................................................................................21

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

6.2. Test laboratory 测试实验室.......................................................................................................................................2

6.3.Implant samples植入物样品 ....................................................................................................................................2

6.4. Animals and implantation 动物和植入.................................................................................................................. 2

6.5. Retrieval and histological procedure检索和组织学程序................................................................................... 2

6.6. Macroscopic and microscopic evaluation宏观和微观评价................................................................................ 23

6.7. Final evaluation 最终评估........................................................................................................................................ 23

Annex A(normative ) Test methods for implantation in subcutaneous tissue

附录A(规范性附录)皮下组织植入试验方法.................................................................................................................... 24

Annex B (normative ) Test method for implantation in muscle

附录B(规范性附录)肌肉植入试验方法............................................................................................................................ 28

Annex C( normative ) Test method for implantation in bone

附录C(规范性附录)骨植入试验方法 .................................................................................................................................. 31

Annex D ( normative ) Test method for implantation in brain tissue

附录D(规范性附录)植入脑组织的试验方法.................................................................................................................... 35

Annex E(informative ) Examples of evaluation of local biological effects after implantation

附件E(资料性)植入后局部生物效应评估示例 ................................................................................................................ 42

Bibliography参考文献 ................................................................................................................................................................ 46

PAGE:2 CISO2016-Allrightsreserved

ISO 10993-6:2016(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。尤其应注意不同类型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，不构成背书。

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,as

well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade(TBT)see

the following URL:Foreword -Supplementary information

关于与合格评定相关的ISO特定术语和表达的含义的解释，以及关于ISO在技术性贸易壁垒(TBT) 中遵守WTO原则的信

息，请参阅以下URL: 前言-补充信息

The committee responsible for this document is ISO/TC 194,Biological and clinical evaluation of medical

devices.

负责本文件的委员会是ISO/TC 194《医疗器械的生物学和临床评估》。

This third edition cancels and replaces the second edition (ISO 10993-6:2007),which has been technically

revised with the following changes:

PAGE:3 CISO2016-Allrightsreserved

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载

标签： #医疗器械 #ISO #生物学评价

摘要：

ISO10993-6:2016(E)中英文版INTERNATIONALSTANDARD国际标准Thirdedition第3版2016-12-01Biologicalevaluationofmedicaldevices—Part6:TestsforlocaleffectsafterImplantation医疗器械生物学评价第6部分：植入后局部反应试验(中英文版)2024年03月翻译ReferencenumberISO10993-6:2016(E)PAGE:1CISO2016-AllrightsreservedISO10993-6:2016(E)中英文版目录Foreword前言.............

展开>> 收起<<

ISO 10993-6-2016 医疗器械生物学评价第6部分：植入后局部反应试验(中英文版).pdf

共49页,预览49页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

ISO 10993-6-2016 医疗器械生物学评价第6部分：植入后局部反应试验(中英文版)

相关推荐

相关内容

热门标签

举报选择: