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IEC/TR 80001-2-1

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

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Organization: IEC
Publication Date: 1 July 2012
Status: active
Page Count: 70
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01
scope:

This technical report provides step-by-step information to aid RESPONSIBLE ORGANIZATIONS in implementation of the RISK MANAGEMENT PROCESS required by IEC 80001-1. Specifically, it details the steps involved in executing subclause 4.4 of IEC 80001-1:2010 and provides guidance in the form of a study of RISK MANAGEMENT terms, RISK MANAGEMENT steps, an explanation of each step, step-by-step examples, templates, and lists of HAZARDS and causes to consider.

The steps outlined within this technical report are considered to be universally applicable. Application of these steps can be scaled as described within this document.

Document History

IEC/TR 80001-2-1
July 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
This technical report provides step-by-step information to aid RESPONSIBLE ORGANIZATIONS in implementation of the RISK MANAGEMENT PROCESS required by IEC 80001-1. Specifically, it details the steps...

References

This document references:
IEC/TR 80001-2-3 - Application of risk management for IT-networks incorporating medical devices – Part 2-3: Guidance for wireless networks
Published by IEC on July 1, 2012
This part of IEC 80001 supports the HDO in the RISK MANAGEMENT of MEDICAL IT-NETWORKS that incorporate one or more wireless links. The report provides technical background concerning wireless...
This document references:
IEC/TR 80001-2-2 - 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
Published by IEC on July 1, 2012
This part of IEC 80001 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...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
IEC/TR 80001-2-2 - 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
Published by IEC on July 1, 2012
This part of IEC 80001 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...
This document references:
IEC/TR 80001-2-3 - Application of risk management for IT-networks incorporating medical devices – Part 2-3: Guidance for wireless networks
Published by IEC on July 1, 2012
This part of IEC 80001 supports the HDO in the RISK MANAGEMENT of MEDICAL IT-NETWORKS that incorporate one or more wireless links. The report provides technical background concerning wireless...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 27799 - Health informatics - Information security management in health using ISO/IEC 27002
Published by ISO on July 1, 2016
This International Standard gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of...
This document is referenced by:
AAMI TIR80001-2-2 - 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
Published by AAMI on January 1, 2012
This part of IEC 80001 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...
This document is referenced by:
IEC/TR 80001-2-4 - Application of risk management for IT-networks incorporating medical devices – Part 2-4: Application guidance – General implementation guidance for healthcare delivery organizations
Published by IEC on November 1, 2012
Purpose This technical report helps a RESPONSIBLE ORGANIZATION through the key decisions and steps required to establish a RISK MANAGEMENT framework, before the organization embarks on a detailed...
This document is referenced by:
AAMI TIR80001-2-4 - Application of risk management for IT-networks incorporating medical devices ─ Part 2-4: General implementation guidance for healthcare delivery organizations
Published by AAMI on January 1, 2012
This technical report helps a RESPONSIBLE ORGANIZATION through the key decisions and steps required to establish a RISK MANAGEMENT framework, before the organization embarks on a detailed RISK...
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