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Abstract Preview

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.


General information

  • Status :  Published
    Publication date : 2016-10
  • Edition : 1
    Number of pages : 45
  • Technical Committee
    :
    ISO/TC 215
    Health informatics
  • ICS :
    35.080
    Software
    35.240.80
    IT applications in health care technology

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    IEC 82304-1:2016

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