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SRPS EN 82304-1:2017

Health Software - Part 1: General requirements for product safety

Dec 25, 2017

General information

60.60     Dec 25, 2017

ISS

N062

European Norm

35.240.80  

English  

plan 2017

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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
SRPS EN 82304-1:2017
60.60 Standard published
Dec 25, 2017

Related project

Adopted from EN 82304-1:2017