IEC 82304-1 Ed. 1.0 b:2016

Current Revision
Health software - Part 1: General requirements for product safety

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IEC 82304-1 Ed. 1.0 b:2016

Health software - Part 1: General requirements for product safety

PUBLISH DATE 2016
PAGES 60
IEC 82304-1 Ed. 1.0 b:2016

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 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.
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