Standard No.:	T/ZMDS 50004-2023
English Name:	Medical device - validation for cleanroom and related controlled environments monitoring system
Chinese Name:	医疗器械 洁净室及相关受控环境监测系统的确认方法
Chinese Classification:	C70    Industrial dust and gas prevention technology
Professional Classification:	T/    Social Organization Standard
ICS Classification:	13.040.35 13.040.35    Cleanrooms and associated controlled environments 13.040.35
Issued on:	2023-12-29
Implemented on:	2023-12-29
Status:	valid
Target Language:	English
File Format:	PDF

本文件确立了医疗器械洁净室及相关受控环境监测系统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企业用于洁净室及相关受控环境监测系统的软件确认过程，此系统包含采购的现成软件（OTSS）及就绪可用软件(RUSP)及其配套环境数据采集设备。