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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| Price Excl. VAT |
Total number of pages, tables and drawings |
|
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.
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| Class |
C
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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.
|
DE version
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EN version
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FR version
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Status
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
Origin
| Committee |
CLC/TC 62
Electrical equipment in medical practice
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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 |
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