ISO13485/' target='_blank'>ISO13485标准概述
The ISO13485 standard overview
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" due to heal the wounded and rescue the dying, to prevent and cure diseases of medical equipment is a special product, according to ISO9000 standard general requirements specification 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 organizations have issued ISO13485: 1996 version of the standard ( YY / T0287 and YY / T0288 ), for the medical device production enterprise quality management system put forward special requirements, for medical equipment quality to achieve safe and effective played a very good role in promoting.