ISO/IEC Guide 63:2019 医疗设备国际标准中安全内容的编制和纳入指南

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

本文件基于完善的风险管理概念和方法，向医疗器械标准的编写者提供了关于在国际标准中纳入安全性相关方面的要求和建议。本文件适用于与人员、财产、环境或其组合的安全相关的任何方面。在本文中，术语“产品”包括医疗设备或由一个或多个医疗设备组成的系统，可能与非医疗设备组合。

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.

标准预览图