PD ISO/TR 80001-2-7:2015
Application of risk management for IT-networks incorporating medical devices. Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
Application of risk management for IT-networks incorporating medical devices. Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
- Статус документа:
- D
- Формат:
- Электронный (PDF)
- Дата публикации:
- 31 марта 2015 г.
- ICS:
- 11.040.01
- SKU:
- PD ISO/TR 80001-2-7:2015
Abstract
1 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.
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