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EN 82304-1:2017

Health Software - Part 1: General requirements for product safety EN 82304-1:2017

Publication date:   Nov 15, 2017

General information

60.60   Standard published   Sep 1, 2017

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

35.240.80   IT applications in health care technology

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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.

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PUBLISHED
EN 82304-1:2017
60.60 Standard published
Sep 1, 2017




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