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IEC 81001-5-1 Ed. 1.0 b:2021
M00002538
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IEC 81001-5-1 Ed. 1.0 b:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
standard by International Electrotechnical Commission, 12/01/2021
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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.