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EVS-EN 82304-1:2017

Health Software - Part 1: General requirements for product safety

General information
Valid from 18.09.2017
Base Documents
IEC 82304-1:2016; EN 82304-1:2017
Directives or regulations
None
Standard history
Status
Date
Type
Name
18.09.2017
Main
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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