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。

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.