BS EN 80001-1-2011 pdf download.Application of risk management for IT-networks incorporating medical devices Part 1: Roles, responsibilities and activities.
b) operational characteristics of the IT infrastructure of the MEDICAL IT-NETWORK (e.g. performance properties such as bandwidth);
c) CONFIGURATION MANAGEMENT information;
d) medical application software;
e) data about configuration of hardware and software;
f) characterization of identifiable patient data on the MEDICAL IT-NETWORK or used by the incorporated MEDICAL DEVICE including its nature, volume, and sensitivity;
g) healthcare procedure support information, including history of use and OPERATOR/user details; and
h) a security description and other materials relevant to total system SAFETY considerations (in case security is an aspect of SAFETY).
Compliance is checked by inspection of the MEDICAL IT-NETWORK RISK MANAGEMENT FILE.
4.3.3 MEDICAL IT-NETWORK documentatIon
The RESPONSIBLE ORGANIZATION shall establish and maintain network documentation necessary to support the RISK MANAGEMENT of the MEDICAL IT-NETWORK for the interfaces between the MEDICAL DEVICE(S) and all network components (both software and hardware). This documentation shall include but not be limited to:
a) physical and logical network configuration;
NOTE 1 The network configuration includes defining the boundanes of the network.
NOTE 2 Documentation can contain IT-NETWORK electrical properties that might impact the performance of the
ME0IcAL IT-NETWORK and incorporated devices. Examples Include, but are not limited to, grounding, galvanic
(de)coupling. stray currents, and power over Ethernet.
b) applied standards and conformance statements;
c) physical and logical client / server structure;
d) network security, reliability and data integrity;
e) network communication requirements for each MEDICAL DEVICE as specified by the manufacturer; and
f) future (planned I reasonably foreseeable) changes I upgrades I enhancements.
Compliance is checked by inspection of the MEDICAL IT-NETWORK RISK MANAGEMENT FILE.
more documented RESPONSIBILITY AGREEMENTS that define (e.g. by contract) the responsibilities of all relevant stakeholders.
A RESPONSIBILITY AGREEMENT may cover one or more projects or the maintenance of one or more MEDICAL IT-NETwoRKs, and shall identify responsibility for all aspects of the MEDICAL IT- NETWORK life cycle and all activities that form part of that life cycle.
NOTE In order to support incorporating MEDICAL DEVICES into an IT-NEtWORK, the MEDICAL DEVICE manufacturers make available technical Information appropriate to the creation of RESPOtISIBLE ORGANIZATION RISK MANAGEMENT documentation. Where the PROCESS requires information that a MEDICAL DEVICE manufacturer believes is sensitive In nature, the provision of the information will be determined by the RESPONSIBILITY AGREEMENT and can be protected by a confidentiality agreement.
The RESPONSIBILITY AGREEMENTS shall contain (or refer to documents which contain) at a minimum:
a) the name of the person responsible for RISK MANAGEMENT for the activities covered by the RESPONSIBILITY AGREEMENT;
b) the scope of the activities covered by the RESPONSIBILITY AGREEMENT, including a summary of and/or reference to the requirements;
C) a list of the MEDICAL DEVICES and other equipment which are to be incorporated into the IT- NETWORK or changed, together with the names of MEDICAL DEVICE manufacturers or other organizations responsible for the provision of technical information necessary for the completion of the project;
d) a list of documents to be supplied by the MEDICAL DEVICE manufacturers and other equipment suppliers that contain instructions for connection to or disconnection from an
IT-NETWORK;
e) technical information to be supplied by the MEDICAL DEVICE or IT manufacturers and other equipment suppliers that is necessary to perform RISK ANALYSIS for the IT-NETWORK; and
1) definition of roles and responsibilities in managing potentially adverse events.
The RESPONSIBLE ORGANIZATION shall provide a summary of responsibilities as appropriate.
NOTE I The manufacturer of a MEDICAL DEVICE is responsible for making available technical documentation on how to use the MEDICAL DEVICE’S interfaces to connect to an IT-NETWORK, provided that such a connection Is Intended by the manufacturer. There Is no such obligation on the supplier of other equipment, and It might be necessary to make a specific arrangement to gain access to such technical documentation
lithe co-operation of manufacturers of MEDICAL DEVICES, suppliers of other equipment or other organizations is necessary in addition to the listed documents supplied by the manufacturers or organizations, a RESPONSIBILITY AGREEMENT shall:BS EN 80001-1-2011 pdf download.