香港ISO13485認證 ISO13485:2016醫療器械質量管理體系用于法規的要求 发布时间: 2020-10-02 11:11 点击:
香港ISO13485認證 ISO13485:2016醫療器械質量管理體系用于法規的要求
Hong Kong ISO13485 certification iso13485:2016 medical device quality management system for regulatory requirements
ISO13485中文叫“醫療器械 質量管理體系 用于法規的要求” 由于醫療器械是救死扶傷、防病治病的特殊産品,僅按ISO9000標准的通用要求來規範是不夠的,爲此ISO組織頒布了ISO13485:1996版標准(YY/T0287 和YY/T0288),對醫療器械生産企業的質量管理體系提出了專用要求,爲醫療器械的質量達到安全有效起到了很好的促進作用。
ISO13485 is called "medical device quality management system for regulatory requirements" in Chinese. Because medical devices are special products for rescuing the dying, preventing and treating diseases, it is not enough to standardize according to the general requirements of ISO9000 standard. Therefore, ISO Organization issued iso13485:1996 standard (YY / T0287) And YY / t0288), put forward special requirements for the quality management system of medical device manufacturers, and played a good role in promoting the quality of medical devices to achieve safety and effectiveness.
2017年11月爲止的執行版本是ISO13485:2016《醫療器械質量管理體系用于法規的要求》。名稱和內容相較以前版本有所改變。
The executive version up to November 2017 is iso13485:2016 "medical device quality management system requirements for regulations". The name and content have changed compared with the previous version.
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