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download between 0-24 hoursReleased: 2016-10-27
IEC 82304-1:2016
Health software - Part 1: General requirements for product safety
Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits
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English/French - Bilingual PDF
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209.00 EUR
English/French - Bilingual Hardcopy
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209.00 EUR
Standard number: | IEC 82304-1:2016 |
Released: | 2016-10-27 |
Language: | English/French - Bilingual |
DESCRIPTION
IEC 82304-1:2016
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.