ISO13485认证 医疗器械质量管理体系(YY/T0287 和YY/T0288)

ISO13485 certified medical device quality management system (YY/T0287 and YY/T0288)

ISO13485中文叫“医疗器械质量管理体系” 由于医疗器械是救死扶伤、防病治病的特殊产品，仅按ISO9000标准的通用要求来规范是不够的；

ISO13485 Chinese called "medical equipment quality management system" as medical apparatus and instruments is to heal the wounded and rescue the dying, to prevent and cure diseases of special products, only according to the general requirements of ISO9000 standard to regulate is not enough;

为此ISO组织颁布了ISO13485：1996版标准(YY/T0287 和YY/T0288)，对医疗器械生产企业的质量管理体系提出了专用要求，为医疗器械的质量达到安全有效起到了很好的促进作用。

This ISO issued ISO13485:1996 version of the standard and YY/T0288 YY/T0287, of the quality management system of medical equipment manufacturing enterprises put forward the special requirements, for the quality of medical devices to achieve safe and effective plays a good role in promoting.

ISO13485 ISO13485认证 ISO13485质量管理体系 ISO13485最新版本 ISO134852012 ISO13485标准下载

ISO13485 ISO13485 certification ISO134852012 quality management system ISO13485 the latest version of ISO13485 ISO13485 standard download