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AAMI TIR80001-2-7

Application of risk management for ITnetworks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to selfassess their conformance with IEC 80001-1

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Organization: AAMI
Publication Date: 1 January 2014
Status: active
Page Count: 116
scope:

The purpose of this technical report is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this Technical Report is to:

1) provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1

2) provide an exemplar assessment method which can be used by HDOs in varying contexts to assess themselves against IEC 80001-1

3) define a PRM comprising a set of processes, described in terms of process purpose and outcomes that demonstrate coverage of the requirements of IEC 80001-1

4) define a PAM that meets the requirements of ISO/IEC 15504-2 and that supports the performance of an assessment by providing indicators for guidance on the interpretation of the process purposes and outcomes as defined in IEC 80001-1 (PRM) and the process attributes as defined in ISO/IEC 15504-2

This technical report does not introduce any requirements in addition to those expressed in IEC 80001-1.

Document History

AAMI TIR80001-2-7
January 1, 2014
Application of risk management for ITnetworks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to selfassess their conformance with IEC 80001-1
The purpose of this technical report is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this Technical Report is to: 1) provide guidance to...

References

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 80001-2-1 - 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
Published by IEC on July 1, 2012
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...
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:
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...
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