Standard No.:	T/ZMDS 40003-2022
English Name:	Medical device - validation for testing software
Chinese Name:	医疗器械 检验用软件的确认方法
Chinese Classification:	C43    Medical radiographic equipment
Professional Classification:	T/    Social Organization Standard
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by:	Zhongguancun Medical Device Industry Technology Innovation Alliance
Issued on:	2022-12-30
Implemented on:	2022-12-30
Status:	valid
Target Language:	English
File Format:	PDF

本文件确立了医疗器械检验用软件的确认和再确认程序，并规定了确认文档的编写要求。
本文件适用于医疗器械研发、生产、质量控制、销售环节中用于检验的软件确认过程，包含采购的现成软件（OTSS）及就绪可用软件(RUSP)。