AAMI IEC TIR 80001-2-2 : 2012
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
Hardcopy , PDF
English
30-09-2012
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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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