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PD ISO/TR 80001-2-7:2015

Current
Current

The latest, up-to-date edition.

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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-31-2015

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Assessment Method
Annex A (informative) - Assessment Method
Annex B (informative) - Process Reference Model
Annex C (informative) - Process Assessment Model
Annex D (informative) - Abbreviations and Process
        Identifiers
Bibliography

Gives guidance to HDOs on self-assessment of their conformance against IEC 80001-1.

The purpose of this part of ISO/TR80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC80001-1. The purpose of this part of ISO/TR80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC80001-1, provide an exemplar assessment method which can be used by HDOs in varying contexts to assess themselves against IEC80001-1, define a PRM comprising a set of processes, described in terms of process purpose and outcomes that demonstrate coverage of the requirements of IEC80001-1, and define a PAM that meets the requirements of ISO/IEC15504-2 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 IEC80001-1 (PRM) and the process attributes as defined in ISO/IEC15504-2. This part of ISO/TR80001 does not introduce any requirements in addition to those expressed in IEC80001-1.

Committee
CH/62/1
DocumentType
Standard
Pages
112
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TR 80001-2-7:2015 Identical

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO/IEC TR 24774:2010 Systems and software engineering Life cycle management Guidelines for process description
ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
ISO/IEC TR 15504-6:2008 Information technology Process assessment Part 6: An exemplar system life cycle process assessment model
ISO/IEC/IEEE 15289:2017 Systems and software engineering Content of life-cycle information items (documentation)
IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
ISO/IEC 15504-2:2003 Information technology Process assessment Part 2: Performing an assessment
ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
ISO/IEC 15504-1:2004 Information technology Process assessment Part 1: Concepts and vocabulary
IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
IEC TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

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Hardcopy - English
PDF - English
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