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IEC 82304-1

IEC 82304-1:2016
Health software - Part 1: General requirements for product safety
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.
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English/French
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Technical committee

TC 62/SC 62A Common aspects of medical equipment, software, and systems

Category

Safety - Information security and data privacy

Keywords

Medical devices
Publication typeInternational Standard
Publication date2016-10-27
Edition1.0
ICS

35.240.80

Stability date2029
ISBN number9782832237335
Pages55
File size1.70 MB
EditionDatePublicationEditionStatus

  • Ensure healthy lives and promote well-being for all

  • Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation

  • Reduce inequality within and among countries

  • Ensure sustainable consumption and production patterns

  • Take urgent action to combat climate change and its impacts

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