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AAMI/IEC TIR80001-2-7:2014

AAMI/IEC TIR80001-2-7:2014

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

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The purpose of this technical report is to provide guidance to HDOs on self-assessment of theirconformance 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 assessthemselves against IEC 80001-1
3)define a PRM comprising a set of processes, described in terms of process purpose and outcomes thatdemonstrate 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 anassessment 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.

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