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IEC 82304-1:2016

Health software — Part 1: General requirements for product safety IEC 82304-1:2016

Publication date:   Oct 31, 2016

General information

90.93 Standard confirmed   Sep 21, 2021

IEC

ISO/TC 215 Health informatics

International Standard

35.240.80   IT applications in health care technology | 35.080   Software

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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
IEC 82304-1:2016
90.93 Standard confirmed
Sep 21, 2021