本文件根据成熟的风险管理概念和方法，就将安全相关方面纳入国际标准向医疗器械标准编写者提出要求和建议。 本文件适用于与人身安全、财产安全、环境安全相关的任何方面，或这些方面的组合。 在本文件中，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，可能与非医疗设备结合使用。交叉引用:IEC 62304ISO 13485IEC 60417ISO/TR 24971ISO 14971IEC指南109ISO 11137- 1ISO 11135ISO/IEC指南37ISO 3864ISO 7010ISO 7001ISO 10993ISO 15223-1ISO/TR 80002-1ISO 7000ISO/IEC指南14ISO/IEC指南41IEC 82079-1ISO 9000:2015ISO/IEC指南51:2014IEC 80001-1:2010ISO/IEC指南2:2004购买本文件时提供的所有当前修订版均包括在内。

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.Cross References:IEC 62304ISO 13485IEC 60417ISO/TR 24971ISO 14971IEC Guide 109ISO 11137-1ISO 11135ISO/IEC Guide 37ISO 3864ISO 7010ISO 7001ISO 10993ISO 15223-1ISO/TR 80002-1ISO 7000ISO/IEC Guide 14ISO/IEC Guide 41IEC 82079-1ISO 9000:2015ISO/IEC Guide 51:2014IEC 80001-1:2010ISO/IEC GUIDE 2:2004All current amendments available at time of purchase are included with the purchase of this document.