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IEC 80001-1-ed.2.0
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
Translate name
STANDARD published on 21.9.2021
The information about the standard:
Designation standards: IEC 80001-1-ed.2.0
Publication date standards: 21.9.2021
SKU: NS-1037568
The number of pages: 75
Approximate weight : 225 g (0.50 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Medical equipment in generalIT applications in health care technology
Annotation of standard text IEC 80001-1-ed.2.0 :
IEC 80001-1:2021 specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS. LIEC 80001-1:2021 specifie des exigences generales au profit des ORGANISATIONS pour l’application de la GESTION DES RISQUES avant, pendant et apres la connexion d’un SYSTEME TI DE SANTE au sein d’une INFRASTRUCTURE TI DE SANTE. Il traite des PROPRIETES CLES de SECURITE, d’EFFICACITE et de SURETE tout en impliquant les intervenants concernes. LIEC 80001-1:2021 annule et remplace la premiere edition parue en 2010. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) modification de la structure pour mieux s’aligner sur l’ISO 31000; b) etablissement d’exigences en faveur d’une ORGANISATION dans l’application de la GESTION DES RISQUES; c) communication de la valeur, de l’objectif et de la finalite de la GESTION DES RISQUES a travers des principes qui favorisent la preservation des PROPRIETES CLES lors de la mise en ouvre et de l’utilisation des LOGICIELS DE SANTE et/ou SYSTEMES TI DE SANTE connectes.
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