This standard was last reviewed and confirmed in 2021. Therefore this version remains current.
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.
Status: PublishedPublication date: 2016-10
Edition: 1Number of pages: 45
Technical Committee: ISO/TC 215 Health informatics
This standard contributes to the following Sustainable Development Goals:
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|std 1 185||Paper|
|std 2 185|
A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)
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