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IEC TR 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 , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

07-10-2012

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

IEC/TR 80001-2-2:2012(E), which is a technical report, creates 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. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.

DevelopmentNote
Stability date: 2017. (09/2017)
DocumentType
Technical Report
Pages
54
PublisherName
International Electrotechnical Committee
Status
Current

Standards Relationship
NEN NPR IEC/TR 80001-2-2 : 2012 Identical
AAMI IEC TIR 80001-2-2 : 2012 Identical
PD IEC/TR 80001-2-2:2012 Identical

AAMI TIR57 : 2016 PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
PD ISO/TR 80001-2-7:2015 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
I.S. EN 82304-1:2017 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
PD IEC/TR 80001-2-9:2017 Application of risk management for it-networks incorporating medical devices Application guidance. Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
EN 82304-1:2017 Health Software - Part 1: General requirements for product safety
AAMI/IEC TIR80001-2-5:2014 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
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
NEMA HN 1 : 2013 MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
BS EN 82304-1:2017 Health Software General requirements for product safety
AAMI/IEC TIR80001-2-8:2016 APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC 80001-2-2
IEC TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
PD IEC/TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2
ANSI/AAMI/IEC TIR80001-2-1:2012 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
PD IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
PD IEC/TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
IEC TR 80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
15/30246774 DC : 0 BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
AAMI/IEC TIR80001-2-7:2014 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
IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
BS IEC 82304-1 : 2016 HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
AAMI TIR57:2016(R2023) Principles for medical device security—Risk management

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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