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Publication details

Publication CODE Title
IEC 81001-5-1:2021 (2021-12) HEALTH SOFTWARE AND HEALTH IT SYSTEMS SAFETY, EFFECTIVENESS AND SECURITY - PART 5-1: SECURITY - ACTIVITIES in THE PRODUCT LIFE CYCLE
 
Price Excl. VAT Total number of pages, tables and drawings
274.00 € 114.
Description
IEC 81001-5-1:2021 defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1 ' 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.
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.
This document excludes specification of ACCOMPANYING DOCUMENTATION contents.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2021-12-16
ICS-Code (International Standards Classification) 11.040.01 , 35.240.80
NBN Status New
IEC publication date 2021-12-16
IEC stability date 2026-12-31
IEC file modification date 2021-12-16
IEC last modification date 2021-12-16