PD ISO/TR 80001-2-7:2015
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
Hardcopy , PDF
English
31-03-2015
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.
| Committee |
CH/62/1
|
| DocumentType |
Standard
|
| Pages |
112
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| 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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