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Reference IEC 80001-1 ed1.0 withdrawn corrigendum

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Title Versión Oficial en Español - Aplicación de la gestión del riesgo para las redes de tecnología de la información que incorporan dispositivos médicos. Parte 1: Funciones, responsabilidades y actividades.
Publication date 2010-10-27
Format, price
(Swiss francs)
and language
230.- 86 pages
230.- 1160 Kb
 
Abstract IEC 80001-1:2010 Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). IEC 80001-1:2010 does not specify acceptable risk levels. IEC 80001-1:2010 applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. It applies throughout the life cycle of IT-networks incorporating medical devices. IEC 80001-1:2010 applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization. It does not apply to personal use applications where the patient, operator and responsible organization are one and the same person.
Technical Committee 62A - Common aspects of electrical equipment used in medical practice  RSS
ICS Codes
11.040.01 Medical equipment in general

35.240.80 IT applications in health care technology
*Including computer tomography
 
Replaced by
Stability date 2016
 
Work in progress
ProjectStage codeForecast publication date
No project under development--


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