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 asssment 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 Obrvations 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 cretariat 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of an identical text or by endorment, at the latest by September 2002, and conflicting national standards shall be withdrawn at the latest by September 2002.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 esntial 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), e 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 Republ
ic, 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。
Introduction 引言
Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) requires in Annex III, ction 3, indent 11 and ction 6.1, in Annex IV, ction 3.2 c) and in Annex V, ction 3, that the manufacturer provides evidence in his technical documentation that the IVD MD performs as claimed, whether the claims are of a technical, analytical or diagnostic nature. Such evidence can be shown by data already available to the manufacturer or by scientific literature or by data originating from performance evaluation studies in a clinical or other appropriate environment in accordance with the intended u.
体外诊断试剂98/79/EC指令要求制造商应在其技术文档中提供证据证明无论制造商对产品的声明是具有技术性的、分析性的还是诊断性的本质，IVD产品均应该符合其声明。这类证据可以包括制造商已
有的数据、科学文献或者根据预期用途在临床环境或其他适当的环境下进行的性能评估数据。
If a performance evaluation study is necessary and appropriate to support performance claims of the IVD MD, this standard describes how the manufacturer can fulfill his obligation to conduct a scientifically sound performance evaluation study. The evaluation plan is adapted to the nature of the IVD MD and its intended u, taking into account the various recommendations given in standards and scientific literature.
如果性能评估研究对于支持IVD产品的声明是必要的和适当的，那么本标准描述了制造商如何能够完成自己的职责来对产品进行科学的性能评估研究。评估的方案应该适合IVD产品的性质和其预期用途，同时应考虑到各种标准和科学文献上给出的各种建议。
Considering the broad range of IVD MDs covered by Directive 98/79/EC and taking into account that, up to now, there is no uniformly applicable document, it is the purpo of this standard to prent the common elements to be considered for a performance evaluation. The applicability of many items described will depend on the level of complexity of the IVD MD.
考虑到98/79/EC指令覆盖了范围很广的IVD产品，以及直到如今也没有可用的一致的文件，本标准的目的正是介绍在进行性能评估时需要进行考虑的通用的因素。本标准描述的许多项目的应用取决于IV
D产品的复杂水平。
At the time of drafting this standard it was envisaged that the European Commission would publish a number of Common Technical Specifications (CTSs) which would be relevant to Directive 98/79/EC on in vitro diagnostic medical devices. It was further envisaged that the would be referenced in the Official Journal of the European Communities. In particular the CTSs will apply to in vitro diagnostic medical devices falling into list A of annex II of the Directive 98/79/EC and possibly a number of in vitro diagnostic medical devices in list B of annex II of the same directive. Manufacturers should therefore take the CTSs into account within the context of Article 5 “Reference to standards”, of the Directive 98/79/EC.
在本标准起草的时候，欧洲委员会正在设想出版一系列与98/79/EC指令相关的体外诊断试剂通用技术规范（CTSs）。进一步的，这些技术规范将被欧洲委员会的官方公报引用。特
别的，这些技术规范适用于98/79/EC指令附录II 中表A中的体外诊断试剂，也可能适用于指令附录II 中表B中的许多产品。因此，制造商应当在指令第5章“标准引用中”考虑到这些技术规范。
