没有合适的资源?快使用搜索试试~ 我知道了~
首页ISO 10993-1-2018.pdf
ISO 10993-1-2018.pdf
需积分: 50 37 下载量 131 浏览量
更新于2023-03-03
评论
收藏 903KB PDF 举报
ISO 10993-1-2018 医疗器械的生物学评价.第1部分:风险管理过程中的评价和试验 供医疗行业相关从业人员下载参考
资源详情
资源评论
资源推荐
©
ISO 2018
Biological evaluation of medical
devices —
Part 1:
Evaluation and testing within a risk
management process
Évaluation biologique des dispositifs médicaux —
Partie 1: Évaluation et essais au sein d'un processus de gestion du
risque
INTERNATIONAL
STANDARD
ISO
10993-1
Fifth edition
2018-08
Reference number
ISO 10993-1:2018(E)
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI
Not for Resale, 08/20/2018 20:10:24 MDT
No reproduction or networking permitted without license from IHS
--`,``,,`,,```,`,`,,`,,`,,`````,-`-`,,`,,`,`,,`---
ISO 10993-1:2018(E)
ii © ISO 2018 – All rights reserved
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
CP 401 • Ch. de Blandonnet 8
Phone: +41 22 749 01 11
Website: www.iso.org
Published in Switzerland
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI
Not for Resale, 08/20/2018 20:10:24 MDT
No reproduction or networking permitted without license from IHS
--`,``,,`,,```,`,`,,`,,`,,`````,-`-`,,`,,`,`,,`---
ISO 10993-1:2018(E)
Foreword ........................................................................................................................................................................................................................................iv
Introduction
..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ..................................................................................................................................................................................... 1
3 Termsanddefinitions ..................................................................................................................................................................................... 2
4 General principles applying to biological evaluation of medical devices ................................................. 5
5 Categorization of medical devices ...................................................................................................................................................... 9
........................................................................................................................................................................................................... 9
........................................................................................................................ 9
5.2.1 Non-contacting medical devices......................................................................................................................... 9
5.2.2 Surface-contacting medical devices .............................................................................................................10
..........................................................................................10
5.2.4 Implant medical devices .........................................................................................................................................11
.............................................................................................................................11
5.3.1 Contact duration categories ................................................................................................................................ 11
.....................................................................................................11
5.3.3 Medical devices with multiple contact duration categories ....................................................11
6 Biological evaluation process ..............................................................................................................................................................12
................................................................. 12
.......................................................12
6.3 Biological testing ................................................................................................................................................................................ 13
................................................................................................................................................................................... 13
6.3.2 Testing for evaluation ............................................................................................................................................... 14
7 Interpretation of biological evaluation data and overall biological risk assessment ...............18
Annex A (informative) Endpoints to be addressed in a biological risk assessment.........................................20
Annex B (informative) Guidance on the conduct of biological evaluation within a risk
management process ....................................................................................................................................................................................25
Annex C (informative) Suggested procedure for literature review ...................................................................................38
Bibliography
.............................................................................................................................................................................................................................40
© ISO 2018 – All rights reserved iii
Contents Page
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI
Not for Resale, 08/20/2018 20:10:24 MDT
No reproduction or networking permitted without license from IHS
--`,``,,`,,```,`,`,,`,,`,,`````,-`-`,,`,,`,`,,`---
ISO 10993-1:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
committee has been established has the right to be represented on that committee. International
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
www
.iso .org/directives).
on the ISO list of patent declarations received (see www
.iso .org/patents).
constitute an endorsement.
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www
.iso .org/iso/foreword .html.
Biological and clinical evaluation of
medical devices.
revised. It also incorporates the Technical Corrigendum ISO 10993-1:2009/Cor.1:2010.
The main changes compared to the previous edition are as follows:
a) revised
b) replaced
A list of all parts in the ISO 10993 series can be found on the ISO website.
iv © ISO 2018 – All rights reserved
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI
Not for Resale, 08/20/2018 20:10:24 MDT
No reproduction or networking permitted without license from IHS
--`,``,,`,,```,`,`,,`,,`,,`````,-`-`,,`,,`,`,,`---
ISO 10993-1:2018(E)
Introduction
from the use of medical devices. It is compiled from numerous International and national standards
and guidelines concerning the biological evaluation of medical devices. It is intended to describe the
evaluation and development of each medical device. This approach combines the review and evaluation
consisting of numerous components made of more than one material.
3.14
in vitro
and ex vivo
of response to the same material among individuals indicate that some patients can have adverse
in vitro
in vivo models.
Informative
management process to medical devices which encompasses biological evaluation.
© ISO 2018 – All rights reserved v
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI
Not for Resale, 08/20/2018 20:10:24 MDT
No reproduction or networking permitted without license from IHS
--`,``,,`,,```,`,`,,`,,`,,`````,-`-`,,`,,`,`,,`---
剩余47页未读,继续阅读
li542487945
- 粉丝: 0
- 资源: 3
上传资源 快速赚钱
- 我的内容管理 收起
- 我的资源 快来上传第一个资源
- 我的收益 登录查看自己的收益
- 我的积分 登录查看自己的积分
- 我的C币 登录后查看C币余额
- 我的收藏
- 我的下载
- 下载帮助
会员权益专享
最新资源
- 2023年中国辣条食品行业创新及消费需求洞察报告.pptx
- 2023年半导体行业20强品牌.pptx
- 2023年全球电力行业评论.pptx
- 2023年全球网络安全现状-劳动力资源和网络运营的全球发展新态势.pptx
- 毕业设计-基于单片机的液体密度检测系统设计.doc
- 家用清扫机器人设计.doc
- 基于VB+数据库SQL的教师信息管理系统设计与实现 计算机专业设计范文模板参考资料.pdf
- 官塘驿林场林防火(资源监管)“空天地人”四位一体监测系统方案.doc
- 基于专利语义表征的技术预见方法及其应用.docx
- 浅谈电子商务的现状及发展趋势学习总结.doc
- 基于单片机的智能仓库温湿度控制系统 (2).pdf
- 基于SSM框架知识产权管理系统 (2).pdf
- 9年终工作总结新年计划PPT模板.pptx
- Hytera海能达CH04L01 说明书.pdf
- 数据中心运维操作标准及流程.pdf
- 报告模板 -成本分析与报告培训之三.pptx
资源上传下载、课程学习等过程中有任何疑问或建议,欢迎提出宝贵意见哦~我们会及时处理!
点击此处反馈
安全验证
文档复制为VIP权益,开通VIP直接复制
信息提交成功
评论0