Glossary · Regulation
IEC 82304-1
IEC 82304-1:2016 Health software — General requirements for product safety
IEC 82304-1 is the product safety standard for health software that runs on general computing platforms such as phones or the cloud, without dedicated hardware.
It covers the whole product, from requirements and validation to accompanying documents and post-market activities, and points to IEC 62304 for the software development process.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →