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IEC 82304-1:2016

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IEC 82304-1:2016

Health software — Part 1: General requirements for product safety

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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.

Author ISO/TC 215 Health informatics
Editor ISO
Document type Standard
Format Paper
Edition 1
Number of pages 45
Weight(kg.) 0.1765
Year 2016
Country Switzerland