ISO13485-2016中文版.pdf

INTERNATIONAL ISO STANDARD 13485 第 3 版 2016-03-01 医疗器械 — 质量管理体系 — 用于法规的要求 Dispositifs m dicauxé — Syst mes de management de la qualitè — é Exigences des fins rà glementairesé Reference number ISO 13485:2016(E) ? ISO 2016 ISO 13485:2016(E) COPYRIGHT PROTECTED DOCUMENT ? ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address belo w or ISO ’ s member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 ? CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@ 2 ? ISO 2016 – All rights reserved ISO 13485:2016(E) 目录 Page 前言 v 引言 vi 1 范围 . 1 2 规范性引用文件