Verkkokauppa
IEC 82304-1:2016 ed1.0 (2016-10)
Health software - Part 1: General requirements for product safety
Soveltamisala
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.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
IEC 62304:2006 Medical device software – Software life cycle processes
IEC 62304:2006/AMD1:2015
IEC 62304:2006/AMD1:2015
Vahvistuspäivä
27.10.2016
Julkaisupäivä
27.10.2016
Painos
1.0
Sivumäärä
55
Julkaisun kieli
englanti