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AAMI TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices—Part 2-7: Application guidance—Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
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AAMI TIR80001-2-7:2014

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

PUBLISH DATE 2016
AAMI TIR80001-2-7:2014
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 exemple 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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR80001-2-7
Publication Date May 1, 2016
Language en - English
Page Count 116
Revision Level
Supercedes
Committee
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