GSO IEC 82304-1:2021
健康软件 第1部分：产品安全通用要求

Health software - Part 1: General requirements for product safety

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标准号

GSO IEC 82304-1:2021

发布

2021年

发布单位

GSO

当前最新

GSO IEC 82304-1:2021

 

 

适用范围

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

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