性能评估

BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

体外诊断医疗器械的性能评估

Content目录

Foreword前言

Introduction引言

1 Scope范围

2 Terms and definitions 术语和定义

3 General requirements for the performance evaluation性能评估一般要求3.1 Responsibilities and resources 职责和资源

3.2 Documentation 文档

3.3 Final assessment and review 最终评定和复核

4 Organization of a performance evaluation study性能评估研究的组织

4.1 Preconditions 准备阶段

4.2 Evaluation plan 评估方案

4.3 Sites and resources 地点和资源

4.4 Basic design information 基本设计信息

4.5 Experimental design 试验设计

4.6 Performance study records 性能研究记录

4.7 Observations and unexpected outcomes 观察和非预期结果

4.8 Evaluation report 评估报告

5 Modifications during the performance evaluation study 性能评估研究中的变更

6 Re-evaluation 再评估

7 Protection and safety of probands 受试人员的保护及安全

Foreword 前言

This document EN 13612:2002 has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN.

EN13612：2002由欧洲标准化委员会TC140“体外诊断试剂医疗器械技术委员会”负责起草，该委员会的秘书处由德国标准化委员会负责。

The European Diagnostic Manufacturers Association (EDMA) has contributed to its preparation. 欧洲诊断试剂制造商委员会（EDMA）对本文亦有贡献。

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at the latest by September 2002.

本欧洲标准在2002年9月份前，无论是通过等同内容的出版物还是进行声明支持，应成为各国的国家标准。最晚在2002年9月前，应对任何与本文有冲突的国家标准应进行作废。

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). 本文是由欧洲委员会和欧洲自由贸易委员会受权欧洲标准化委员会起草的，本文支持欧盟指令中的基本要求。

For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.

本文与欧盟指令的关系，请参考作为本文一部分的资料性附录ZA。

Annex ZA is for information only.

附录ZA仅是信息性的。

This standard includes a Bibliography.

本指南包含了一个参考文献目录。

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

根据CEN和CENELEC的内部规定，以下国家的国家标准化委员会必须执行本标准：澳大利亚、比利时、捷克、丹麦、芬兰、法国、德国、希腊、冰岛、爱尔兰、意大利、卢森堡、马尔他、荷兰、挪威、葡萄牙、西班牙、瑞士、瑞典和英国。