DIN EN 80001-1 VDE 0756-1:2011-11

* German Language Version *

Application of risk management for IT-networks incorporating medical devices

Part 1: Roles, responsibilities and activities

(IEC 80001-1:2010); German version EN 80001-1:2011
Class/Status: Standard, valid
Released: 2011-11
VDE Art. No.: 0756001

Contents

This international standard 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). This standard applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. This standard applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. This standard does not address regulatory or legal requirements.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons
35	INFORMATION TECHNOLOGY. OFFICE MACHINES
35.020	Information technology (IT) in general
35.030	IT Security
35.040	Information coding
35.060	Languages used in information technology
35.080	Software. Programms
35.100	Open systems interconnection (OSI)
35.110	Networking
35.160	Microprocessor systems
35.200	Interface and interconnection equipment
35.240	Applications of information technology
35.260	Office machines

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