PD IEC/TR 80001-2-5:2014
Current
The latest, up-to-date edition.
Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
Hardcopy , PDF
English
16-12-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/62/1
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| DocumentType |
Standard
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| Pages |
44
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| PublisherName |
British Standards Institution
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| Status |
Current
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IEC TR 80001-2-5:2014(E) which is a technical report, gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This technical report applies to the transmission of alarm conditions between sources, integrator and communicators where at least one source is a medical device and at least one communication path utilizes a medical IT-network. This technical report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety and effectiveness. Data and systems security is an important consideration for the risk management of distributed alarm systems.
| Standards | Relationship |
| IEC TR 80001-2-5:2014 | Identical |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC TR 80001-2-3:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| NFPA 72 : 2016 | NATIONAL FIRE ALARM AND SIGNALING CODE |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| VDE 0834-1 : 2016 | Call systems in hospitals, nursing homes and similiar institutions Part 1: Requirements for equipment, planning, erection and operation |
| IEC TR 80001-2-4:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations |
| VDE 0834-2 : 2000 | CALL SYSTEMS IN HOSPITALS, NURSING HOMES AND SIMILAR INSTITUTIONS - ENVIRONMENTAL CONDITIONS AND ELECTROMAGNETIC COMPATIBILITY |
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