ISO/IEC GUIDE 63-2012 标准详情
- 标准号:ISO/IEC GUIDE 63-2012
- 中文标题:医疗器械安全方面的开发并纳入国际标准指南
- 英文标题:guide to the development and inclusion of safety aspects in international standards for medical devices
- 标准类别:国际标准化组织标准ISO
- 发布日期:2012-01-10
ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the c
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