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SSH EN 82304-1:2017

Health Software - Part 1: General requirements for product safety

Mar 29, 2019

General information

60.60     Jan 28, 2019

DPS

DPS/KT 6

European Norm

35.240.80  

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Scope

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.

Life cycle

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PUBLISHED
SSH EN 82304-1:2017
60.60 Standard published
Jan 28, 2019

Related project

Adopted from EN 82304-1:2017

Adopted from IEC 82304-1 Ed. 1.0 b