标准摘要
[中文适用范围]： 本文件提供了编写医疗设备标准的人员在国际标准中包含安全方面的指南，基于已建立的风险管理概念和方法。适用于任何与人员、财产、环境或其组合相关的安全方面。本文件中的'产品'包括医疗器械或由一个或多个医疗器械组成的系统，可能与其他非医疗器械结合使用。 [外文原描述]： 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.
英文名称Guide to the development and inclusion of aspects of safety in International Standards for medical devices