IEC 80001-1:2010

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.