IEC 82304-1:2016 

Health software - Part 1: General requirements for product safety

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Abstract

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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Relevant for

medical devices


Additional information

Publication typeInternational Standard
Publication date2016-10-27
Edition1.0
Available language(s)English/French
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS35.240.80 - IT applications in health care technology
Stability date  2020
Pages55
File size1787 KB

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