Your cart is currently empty!
“ISO 80601:2019 Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation” has been added to your cart. View cart
ISO 80001:2012
ISO 80001:2012 Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls
CDN $564.00
Description
IEC/TR 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.
Edition
1
Published Date
2012-07-13
Status
PUBLISHED
Pages
48
Language
English
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 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 20069:2019 Guidance for assessment and evaluation of changes to drug delivery systems
CDN $312.00 Add to cart -
ISO 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 – Devices for administration of medicinal products and catheters
CDN $76.00 Add to cart -
ISO 80001:2017 Application of risk management for IT-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
CDN $441.00 Add to cart -
ISO 15223:2010 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validation
CDN $173.00 Add to cart
