IEC 80001-1:2010 

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

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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.

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Additional information

Publication typeInternational Standard
Publication date2010-10-27
Edition1.0
Available language(s)English/French, Spanish
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Stability date  2021
Pages86
File size1431 KB

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