PD ISO/TR 80001-2-7:2015 PDF

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

First page of standard PD ISO/TR 80001-2-7:2015

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Title (English):

PD ISO/TR 80001-2-7:2015

Format:: Electronic (PDF)
Publication date:: March 31, 2015
ICS:: 11.040.01
SKU:: PD ISO/TR 80001-2-7:2015

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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.

Related standards

Standards mentioned in the description

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

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

PD ISO/TR 80001-2-7:2015 PDF

Abstract

Related standards

Abstract

Related standards

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