90.93 Standard confirmed Sep 21, 2021
IEC
ISO/TC 215 Health informatics
International Standard
35.240.80 IT applications in health care technology | 35.080 Software
Published
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.
PUBLISHED
IEC 82304-1:2016
90.93
Standard confirmed
Sep 21, 2021