Standard No.:	T/SHSPTA 005-2024
English Name:	Specifications for the evaluation of the computer information system of medical device distributors
Chinese Name:	医疗器械经营企业计算机信息系统评价规范
Chinese Classification:	C07    Computer application
Professional Classification:	T/    Social Organization Standard
ICS Classification:	03.120.10 03.120.10    Quality management and quality assurance 03.120.10
Source Content Issued by:	Shanghai Pharmaceutical Association; Shanghai Medical Device Association
Issued on:	2024-06-26
Implemented on:	2024-7-1
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了医疗器械经营企业计算机信息系统在功能、操作、判断、控制、网络及计算机软硬件环境等方面的要求、评价规则及评价方法。
本文件适用于医疗器械经营企业计算机信息系统的开发、遴选、第三方机构评估、监管部门监督检查等用途。