标准编号：ISO/IEC Guide 63:2019
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 aspects of safety in International Standards for medical devices
发布日期：2019-08
标准范围
This document provides requirements and recommendations to writers of medical device standards
on the inclusion of aspects related to safety in International Standards, based on well-established risk
management concepts and methodology.
This document is applicable to any aspect related to the safety of people, property, the environment, or
a combination of these.
In this document, the term “product” includes a medical device or a system consisting of one or more
medical devices, possibly combined with non-medical devices.
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