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AAMI
AAMI IEC TIR 80001-2-2 : 2012

AAMI IEC TIR 80001-2-2 : 2012

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-30-2012

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
IEC/TR 80001-2-2:2012
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Use of SECURITY CAPABILITIES
5 SECURITY CAPABILITIES
6 Example of detailed specification under SECURITY
  CAPABILITY: Person authentication - PAUT
7 References
8 Other resources
9 Standards and frameworks
Annex A (informative) - Sample scenario showing
        the exchange of security information
Annex B (informative) - Examples of regional
        specification on a few SECURITY CAPABILITIES
Annex C (informative) - SECURITY CAPABILITY
        mapping to C-I-A-A
Bibliography

Describes a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection.

Committee
WG 02
DocumentType
Standard
ISBN
1570204616
Pages
68
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
IEC TR 80001-2-2:2012 Identical

AAMI TIR57 : 2016 PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO/IEC 15408-2:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 2: Security functional components
ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
ISO/IEC 15408-3:2008 Information technology — Security techniques — Evaluation criteria for IT security — Part 3: Security assurance components
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO/IEC 27002:2013 Information technology Security techniques Code of practice for information security controls
NEN 7510 : 2011 HEALTH INFORMATICS - INFORMATION SECURITY MANAGEMENT IN HEALTHCARE
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
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 20000-1:2011 Information technology Service management Part 1: Service management system requirements
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO/IEC 20000-2:2012 Information technology Service management Part 2: Guidance on the application of service management systems
ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
ISO/TS 13606-4:2009 Health informatics Electronic health record communication Part 4: Security
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
IEC 61907:2009 Communication network dependability engineering
ISO/IEC 15408-1:2009 Information technology — Security techniques — Evaluation criteria for IT security — Part 1: Introduction and general model
ISO 14971:2007 Medical devices Application of risk management to medical devices
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
ISO/TS 25238:2007 Health informatics Classification of safety risks from health software
ISO 27799:2016 Health informatics Information security management in health using ISO/IEC 27002

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Hardcopy - English
PDF - English - DRM
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