PD ISO/TR 80001-2-7:2015

This standard PD ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices. Application guidance is classified in these ICS categories:

• 11.040.01 Medical equipment in general
• 35.240.80 IT applications in health care technology

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

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, and

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