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PD IEC/TR 80001-2-2:2012

Current
Current

The latest, up-to-date edition.

Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-07-2012

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.

Committee
CH/62/1
DocumentType
Standard
Pages
58
PublisherName
British Standards Institution
Status
Current

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

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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