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Publication details

Publication CODE Title
NBN EN IEC 81001-5-1:2022 (2022-02) HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY, EFFECTIVENESS AND SECURITY - PART 5-1: SECURITY - ACTIVITIES in THE PRODUCT LIFE CYCLE
 
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14.00 € 3.
Description
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.
Class  C
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally only available in English or French. Only the cover page is translated and the document itself is in English or in French.

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Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee CLC/TC 62
Electrical equipment in medical practice
Approval
BEC Approval 2022-01-20
NBN Approval 2022-02-16
NBN Status New
Date of ratification (d.o.r.) 2022-01-20
Date of announcement (d.o.a.) 2022-04-20
Date of publication (d.o.p.) 2022-10-20
Date of withdrawal former edition (d.o.w.) 2025-01-20
IEC file modification date 2022-02-12