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ISO TR 80001-2-7

Application of risk management for IT-networks incorporating medical devices - 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: ISO
Publication Date: 1 April 2015
Status: active
Page Count: 110
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01
scope:

The purpose of this part of ISO/TR 80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this part of ISO/TR 80001 is to

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

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

c) 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, and

d) 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 part of ISO/TR 80001 does not introduce any requirements in addition to those expressed in IEC 80001-1.

Document History

ISO TR 80001-2-7
April 1, 2015
Application of risk management for IT-networks incorporating medical devices - 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 part of ISO/TR 80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this part of ISO/TR 80001 is to a) provide...

References

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