Standard

IEC 82304-1:2016 ED1

Published

Corrigendums and amendments are bought separately.

Language
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Abstract

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.

Document information

  • Standard from IEC
  • Published:
  • Edition: 1
  • Version: 1
  • Document type: IS
  • Pages
  • ICS 35.240.80
  • ISO TC TC 62/SC 62A

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