CEI EN 80001-1 PDF

Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), 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 international standard does not specify acceptable RISK levels.

NOTE 1 The RISK MANAGEMENT activities described in this standard are derived from those in ISO 14971 [4]. The relationship between ISO 14971 and this standard is described in Annex A. This standard applies after a MEDICAL DEVICE has been acquired by a RESPONSIBLE ORGANIZATION and is a candidate for incorporation into an IT-NETWORK.

NOTE 2 This standard does not cover pre-market RISK MANAGEMENT. This standard applies throughout the life cycle of IT-NETWORKS incorporating MEDICAL DEVICES.

NOTE 3 The life cycle management activities described in this standard are very similar to those of ISO/IEC 20000-2 [10]. The relationship between ISO/IEC 20000-2 and this standard is described in Annex D.

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.

NOTE 4 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, the installation or assembly of the MEDICAL DEVICE according to the manufacturer’s ACCOMPANYING DOCUMENTS is not subject to the provisions of this standard regardless of who installs or assembles the MEDICAL DEVICE.

NOTE 5 If a single manufacturer specifies a complete MEDICAL DEVICE that includes a network, additions to that MEDICAL DEVICE or modification of the configuration of that MEDICAL DEVICE, other than as specified by the manufacturer, is subject to the provisions of this standard.

This standard 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. This standard does not apply to personal use applications where the patient, OPERATOR and RESPONSIBLE ORGANIZATION are one and the same person.

NOTE 6 In cases where a MEDICAL DEVICE is used at home under the supervision or instruction of the provider, that provider is deemed to be the RESPONSIBLE ORGANIZATION. Personal use where the patient acquires and uses a MEDICAL DEVICE without the supervision or instruction of a provider is out of scope of this standard.

This standard does not address regulatory or legal requirements.