IEC 82304-1:2016

Health software — Part 1: General requirements for product safety

Publication date: 31 tet 2016

General information

Current stage: 90.20 Effective date: 15 korr 2026

Originator: IEC

Owner: ISO/TC 215

Type: International Standard

ICS: 35.240.80 35.080

Gjuha: anglisht frëngjisht

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Statusi: Publikuar

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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
90.20 Standard under periodical review
15 korr 2026

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