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Norm

IEC 82304-1:2016 Ed. 1.0

Ausgabedatum: 2016 10 27

Health software - Part 1: General requirements for product safety

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...
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Herausgeber:
International Electrotechnical Commission
Format:
Digital | 55 Seiten
Sprache:
Englisch
ICS
35.240.80
Fachgebiete
IT, communication & electronic, Applications of information technology, IT applications in health care technology Healthcare, Health care. Medicine, IT applications in health care technology
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.