IEC 81001-5-1 Ed. 1.0 b:2021
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Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] – 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. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2.
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