Health software and health IT systems safety, effectiveness and security
Part 5-1: Security – Activities in the product life cycle
(IEC 81001-5-1:2021); German version EN IEC 81001-5-1:2022 Class/Status:
VDE Art. No.: 0701470
This document defines the Life Cycle requirements for development and maintenance of Health Software needed to support conformity to IEC 62443-4-1 – taking the specific needs for Health Software into account. The set of Processes, Activities, and Tasks described in this document establishes a common framework for secure Health Software Life Cycle Processes.
This Document is related to the following Topics (in bold):
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