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AAMI/IEC TIR80001-2-7:2014

Current
Current

The latest, up-to-date edition.

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL - APPLICATION GUIDANCE - PART 2-7: 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

24-12-2014

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TR 80001-2-7 Ed.1
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
WG 02
DocumentType
Standard
ISBN
1-57020-579-5
Pages
116
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

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 15289:2006 Systems and software engineering Content of systems and software life cycle process information products (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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