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BSI BS EN IEC 81001-5-1:2022

Health software and health IT systems safety, effectiveness and security -- Security. Activities in the product life cycle
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BSI BS EN IEC 81001-5-1:2022

Health software and health IT systems safety, effectiveness and security -- Security. Activities in the product life cycle

PUBLISH DATE 2022
PAGES 66
BSI BS EN IEC 81001-5-1:2022
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. [Figure 2] [derived from IEC 62304:2006[8], Figure 2] Figure 2 - HEALTH SOFTWARE LIFE CYCLE PROCESSES The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves. It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1[17]. This document excludes specification of ACCOMPANYING DOCUMENTATION contents.
SDO BSI: British Standards Institution
Document Number IEC 81001-5-1
Publication Date Feb. 16, 2022
Language en - English
Page Count 66
Revision Level
Supercedes
Committee CH/62/1
Publish Date Document Id Type View
Feb. 16, 2022 BS EN IEC 81001-5-1:2022 Revision
April 9, 2026 BS EN IEC 81001-5-1:2022 Consolidated