IEC 82304-1:2016

Title

Language: EN Health software - Part 1: General requirements for product safety

Language: FR Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits

Abstract

Language: EN 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.

Language(s)
Language: EN Language: FR
Edition
1.0
Date of issue
27.10.2016
TC 62/SC 62A
ICS Codes
35.240.80
Publication number
82304
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€ 154,50 (Download and hardcopy)
Delivery format
postal download (55 Pages)

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Mandatory Standard according current regulation Mandatory Standard according current regulation

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