Status : Published (Under review)
This standard was last reviewed and confirmed in 2021. Therefore this version remains current.
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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.

General information

  • Status
     : Published
    Publication date
     : 2016-10
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 1
    Number of pages
     : 45
  • Technical Committee :
    ISO/TC 215
    ICS :
    35.080  35.240.80 
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

10
Reduced Inequalities
12
Responsible Consumption and Production
3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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