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SAME AS IEC 82304-1

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 History

  1. DANSK DSF/FPREN 82304-1


    Health Software – Part 1: General requirements for product safety

    • Historical Version
  2. DANSK DS/EN 82304-1

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    Health Software – Part 1: General requirements for product safety

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