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Standard ÖVE EN IEC 81001-5-1 1.8.2023 preview

ÖVE EN IEC 81001-5-1

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (german version)

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STANDARD published on 1.8.2023


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The information about the standard:

Designation standards: ÖVE EN IEC 81001-5-1
Publication date standards: 1.8.2023
SKU: NS-1149488
The number of pages: 66
Approximate weight : 198 g (0.44 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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The category - similar standards:

Medical equipment in generalIT applications in health care technology

Annotation of standard text ÖVE EN IEC 81001-5-1 :

Dieses Dokument definiert die Anforderungen an den LEBENSZYKLUS für die Entwicklung und Wartung von GESUNDHEITSSOFTWARE, die zur Unterstützung der Konformität mit IEC 62443-4-1 [11] erforderlich sind - unter Berücksichtigung der spezifischen Erfordernisse für die GESUNDHEITSSOFTWARE. Die Zusammenstellung von PROZESSEN, AKTIVITÄTEN und AUFGABEN, die in diesem Dokument beschrieben werden, legt einen allgemeinen Rahmen für sichere GESUNDHEITSSOFTWARE-LEBENSZYKLUSPROZESSE fest. Bild 2 enthält einen informativen Überblick über AKTIVITÄTEN für GESUNDHEITSSOFTWARE. Ziel ist es, die IT-SICHERHEIT von GESUNDHEITSSOFTWARE zu erhöhen, indem bestimmte AKTIVITÄTEN und AUFGABEN in den GESUNDHEITSSOFTWARE-LEBENSZYKLUSPROZESSEN vorgesehen werden und auch die IT-SICHERHEIT der SOFTWARE-LEBENSZYKLUSPROZESSE selbst erhöht wird. Es ist wichtig, ein angemessenes Gleichgewicht zwischen den Schlüsseleigenschaften SICHERHEIT, Effektivität und IT-SICHERHEIT zu erhalten, wie in ISO 81001-1 [17] erläutert.

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