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

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.

General Information

Status
Published
Publication Date
15-Dec-2014
Current Stage
PPUB - Publication issued
Start Date
15-Feb-2015
Completion Date
16-Dec-2014
Ref Project

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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
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IEC TR 80001-2-5
Edition 1.0 2014-12
TECHNICAL
REPORT

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

IEC TR 80001-2-5:2014-12(en)

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IEC TR 80001-2-5


Edition 1.0 2014-12




TECHNICAL



REPORT









colour

inside










Application of risk management for IT-networks incorporating medical devices –

Part 2-5: Application guidance – Guidance on distributed alarm systems



























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ICS 11.040.01; 35.240.80 ISBN 978-2-8322-1969-0



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– 2 – IEC TR 80001-2-5:2014 © IEC 2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 Functions of the distribution of ALARM CONDITIONS . 16
4.1 General . 16
4.2 SOURCES and their ALARM CONDITIONS . 17
4.3 INTEGRATOR . 17
4.4 COMMUNICATOR .
...

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