Standard No.:	YY/T 1473-2023
English Name:	Guide for standardization for medical devices―Inclusion of safety aspects in the development of standards
Chinese Name:	医疗器械标准化工作指南涉及安全内容的标准制定
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	State Drug Administration
Issued on:	2023-01-13
Implemented on:	2024-1-15
Status:	valid
Superseding:	YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices
Language:	English
File Format:	PDF
Word Count:	12500 words
Price(USD):	375.00
Delivery:	via email in 1~5 business day

本文件为标准编写者提供了在医疗器械标准中纳入与安全有关内容的要求和建议。这些要求和建议基于已建立的风险管理概念和方法。
本文件适用于医疗器械标准中涉及的人员、财产、环境或这些因素组合的安全有关内容。
文件中，术语“产品”包括单个医疗器械或由一个或多个医疗器械（也可能与非医疗器械组合使用）组成的系统。