Standard

NEK EN 82304-1:2017

Publisert

Rettelser og tillegg kjøpes separat.

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Omfang

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.

Dokumentinformasjon

  • Standard fra NEK
  • Publisert:
  • Utgave: 2017-09
  • Versjon: 1
  • Varetype: NAT
  • Products.Specs.pages
  • ICS 35.240.80
  • National Committee NEK/NK62

Referanser i lov

EU lov:
Lov referanseRestriksjoner
93/42/EEC

Produktrelasjon

  • Adoptert fra: EN 82304-1:2017, 0