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IEC 82304-1:2016 ED1

Health software - Part 1: General requirements for product safety

Oct 27, 2016

General information

60.60     Oct 27, 2016

IEC

TC 62/SC 62A

International Standard

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.

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PUBLISHED
IEC 82304-1:2016 ED1
60.60 Standard published
Oct 27, 2016