IEC 82304-1-ed.1.0

Annotation of standard text IEC 82304-1-ed.1.0 :

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. LIEC 82304-1:2016 sapplique a la securite et a la surete des produits logiciels de sante concus pour fonctionner sur des plates-formes informatiques generales et destines a etre commercialises sans materiel dedie. Ce document se concentre principalement sur les exigences destinees aux fabricants. Il couvre le cycle de vie complet y compris la conception, le developpement, la validation, linstallation, la maintenance et lelimination des produits logiciels de sante.