医疗器械分类指南1中英文对照.pdf

EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical De ices, Metrology 欧盟委员会 DG组织 G委员会 第四部分 医疗器械分类 MEDICAL DEVICES: Guidance document MEDDEV 2.4/1 Re «8 Jidy 2001 GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES 医疗器械，指南文件 MEDDEV 2.4/1 Re ^ 2001年7月 医疗器械分类指南 The present Guidelines are part of a set of Guidelines relating to questions of application of EC Directives on medical devices They are legally not binding The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document Therefore, this document reflects positions taken by representatives of interested parties in the medical devices sector Note : This document is a revision of an earlier document published in December 1999 as MEDDEV 2 4/ 1 rev 6 这是目前与EC指令有关的指南性文件，他们是合法的但并不具有约束力。这份 指南通过各种相关组织的咨询与推敲而订立。(主管当局，委员会，企业以及其 他相关组织)，草案已经经过流通，注解已经在下文中出现。因此，这份文件反 映了医疗器械相关部门当事人的想法。 注意：这份文件是1999年发布的MEDDEV 2 4/ 1 rev 6的升级版。 1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION_______________________________________ 3 2. PRACTICAL RELEVANCE OF CLASSIFICATION________ 2 1 General requirements 2 2 Conformity assessment 2 3 Clinical data 2 4 Labelling 2 5 Miscellaneous 3. HOW TO CARRYOUT CLASSIFICATION_________________ i 3 1 Basic definitions 3 2 Application rules 3 3 How to use the rules and the decision tree 3 4 Practical example 3 5 Handling of interpretational problems 4. EXPLANATIONS OF INDIVIDUAL RULES_____________ 4 1 Graphical summary - Guidance chart 4 2 General e?q)lanation of rules/Practical issues/Exan^les APPENDICES: 1 Annex IX of the Medical De