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IEC 82304-1:2016

Health software - Part 1: General requirements for product safety

General information
Valid from 27.10.2016
Directives or regulations
None

Standard history

Status
Date
Type
Name
27.10.2016
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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PDF
249.11 € incl tax
Paper
249.11 € incl tax
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