IEC 82304-1:2016 ED1

Health software - Part 1: General requirements for product safety

Publication date: 27 tet 2016

General information

Current stage: 60.60 Effective date: 27 tet 2016

Originator: IEC

Owner: TC 62/SC 62A

Type: International Standard

ICS: 35.240.80

Gjuha: anglisht frëngjisht

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Statusi: Publikuar

PDF - 21 483 Lekë

Paper - 21 483 Lekë

CD - 21 483 Lekë

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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
27 tet 2016