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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
    Edition: 2022
    $497.46
    / user per year

Description of BS EN IEC 81001-5-1:2022 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.

Standard NumberBS EN IEC 81001-5-1:2022
TitleHealth software and health IT systems safety, effectiveness and security - Security. Activities in the product life cycle
StatusDefinitive
Publication Date2022-02-16
Identical National Standard OfEN IEC 81001-5-1:2022, IEC 80001-5-1 Ed.1.0, EN IEC 81001-5-1:2022
DescriptorsSafety, Products, Life cycle, Medical equipment, Security
ICS11.040.01 Medical equipment in general, 35.240.80 IT applications in health care technology
CommitteeCH/62/1
ISBN978 0 539 02449 4
PublisherBSI
Pages66

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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