
ISO 80001:2014
ISO 80001:2014 Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance for distributed alarm systems
CDN $506.00
Description
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.
Edition
1
Published Date
2014-12-17
Status
PUBLISHED
Pages
33
Format 
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-

ISO 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 – Devices for administration of medicinal products and catheters
CDN $86.00 Add to cart -

ISO 15223:2025 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements – Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
CDN $35.00 Add to cart -

ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
CDN $382.00 Add to cart -

ISO 62304:2015 Medical device software – Software life cycle processes – Amendment 1
CDN $574.00 Add to cart







