标准编号：ISO/IEC Guide 63:2012
中文名称：医疗设备国际标准中安全内容的编制和纳入指南
英文名称：Guide to the development and inclusion of safety aspects in International Standards for medical devices
发布日期：2012-01
标准范围
This Guide 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 concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.This Guide is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
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