IEC Technical Report 80001-2-5
IEC TR 80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
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.
CHFÂ 260.-
Technical committee
TC 62/SC 62A Common aspects of medical equipment, software, and systemsCategory
Safety - Information security and data privacy| Publication type | Technical Report |
| Publication date | 2014-12-16 |
| Edition | 1.0 |
| ICS | 11.040.01 35.240.80 |
| Stability date | 2026 |
| ISBN number | 9782832219690 |
| Pages | 39 |
| File size | 1.20 MB |
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