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IEC TR 80001-2-5:2014

Current

Current

The latest, up-to-date edition.

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

16-12-2014

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Functions of the distribution of ALARM CONDITIONS
5 Types of systems for distributing ALARM CONDITIONS
6 RISK MANAGEMENT
Annex A (informative) - Correspondence between the
        RISK CONTROL measures of this technical report
        and IEC 60601-1-8
Annex B (informative) - Types of SOURCES
ANNEX C (informative) - Applicability of types of system
        for the distribution of ALARM CONDITIONS
Annex D (informative) - Scalability of types of system for
        the distribution of ALARM CONDITIONS
Bibliography
Index of defined terms used in this technical report

IEC TR 80001-2-5:2014(E) which is a technical report, gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This technical report applies to the transmission of alarm conditions between sources, integrator and communicators where at least one source is a medical device and at least one communication path utilizes a medical IT-network. This technical report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety and effectiveness. Data and systems security is an important consideration for the risk management of distributed alarm systems.

DevelopmentNote
Stability date: 2018. (12/2014)
DocumentType
Technical Report
Pages
39
PublisherName
International Electrotechnical Committee
Status
Current

Standards Relationship
AAMI/IEC TIR80001-2-5:2014 Identical
VDE 0756-2-5 : 2016 Identical
DIN IEC/TR 80001-2-5 : 2016 Identical
PD IEC/TR 80001-2-5:2014 Identical

BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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 80001-2-2:2012 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
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
NFPA 72 : 2016 NATIONAL FIRE ALARM AND SIGNALING CODE
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
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
VDE 0834-1 : 2016 Call systems in hospitals, nursing homes and similiar institutions Part 1: Requirements for equipment, planning, erection and operation
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
VDE 0834-2 : 2000 CALL SYSTEMS IN HOSPITALS, NURSING HOMES AND SIMILAR INSTITUTIONS - ENVIRONMENTAL CONDITIONS AND ELECTROMAGNETIC COMPATIBILITY

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