ISO/IEC Guide 63:2012 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 63:2012

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 safety aspects in International Standards for medical devices

发布日期：2012-01

标准范围

ISO/IEC指南63:2012为标准编写者提供了关于如何将安全方面纳入医疗器械安全标准制定中的指导，这些标准旨在用于ISO 14971建立的风险管理框架。它扩展了ISO/IEC指南51中开发的概念，包括与安全相关的性能和可用性。ISO/IEC指南63:2012旨在与ISO/IEC指南51和ISO 14971一起阅读。

ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.

ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

标准预览图