DIN EN 80001-1 VDE 0756-1:2018-09

DIN EN 80001-1 VDE 0756-1:2018-09

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management (IEC 62A/1244/CD:2018), Text in German and English

42,45 €

Détails

The implementation and use of connected medical devices or health software to support health IT systems and services entails risk. This international standard provides general requirements for applying risk management to Health Information Technology (HIT) systems by addressing the key properties of safety, effectiveness and both data and system security (including privacy) while engaging appropriate stakeholders. In this context, 'implementation' refers to the technology lifecycle phases and activities that are required after health software or medical devices have been released and made available to the market and are being prepared for connection and use.

Informations supplémentaires

Auteur VDE
Type de document Projet de norme
ICS 11.040.01 : Matériel médical en général
35.110 : Réseaux
35.240.80 : Applications des TI dans les technologies de la santé
Nombre de pages 72
Produits apparentés IEC 62A/1244/CD (2018-01), IDT
Poids (kg.) 0.22
Historique
Mot-clé DIN EN 80001,EN 80001,EN 80001-1,80001
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