IEC TR 80001-2-5:2014

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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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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
W
ICS 11.040.01; 35.240.80 ISBN 978-2-8322-1969-0

– 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 . 17
4.5 MEDICAL IT-NETWORK . 18
5 Types of systems for distributing ALARM CONDITIONS . 18
5.1 General . 18
5.2 DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS . 19
5.3 DISTRIBUTED ALARM SYSTEM . 19
5.4 DISTRIBUTED ALARM SYSTEM WITH OPERATOR CONFIRMATION . 19
6 RISK MANAGEMENT . 20
6.1 General explanation . 20
6.2 Determining the RESPONSIBLE ORGANIZATION’S objective purpose . 20
6.3 HAZARDS and HAZARDOUS SITUATIONS related to DIS, DAS and CDAS . 21
6.4 Causes and resulting HAZARDOUS SITUATIONS . 21
6.5 RISK CONTROL measures related to the integration of ALARM CONDITIONS . 23
6.5.1 Technical RISK CONTROL measures implemented in equipment . 23
6.5.2 Typical RISK CONTROL measures for implementation by the RESPONSIBLE
ORGANIZATION . 25
6.5.3 Organizational policies and procedures as RISK CONTROL measures for
implementation by the RESPONSIBLE ORGANIZATION . 26
Annex A (informative) Correspondence between the RISK CONTROL measures of this
technical report and IEC 60601-1-8 . 28
Annex B (informative) Types of SOURCES . 29
B.1 MEDICAL DEVICES . 29
B.2 NURSE CALL SYSTEM . 30
ANNEX C (informative) Applicability of types of system for the distribution of ALARM
CONDITIONS . 32
Annex D (informative) Scalability of types of system for the distribution of ALARM
CONDITIONS . 35
Bibliography . 37
Index of defined terms used in this technical report . 38

Figure 1 – Focus of this technical report . 6
Figure 2 – Functions of a MEDICAL IT-NETWORK incorporating SOURCES, an INTEGRATOR
and COMMUNICATORS to distribute ALARM CONDITIONS . 7
Figure C.1 – Cascading structure of system for the distribution of ALARM CONDITIONS . 32
Figure C.2 – Example for INTEGRATOR of a PATIENT monitor with central monitoring
station to distribute ALARM CONDITIONS in a physically isolated IT-NETWORK in a CDAS . 33

Figure C.3 – Example for INTEGRATOR of a PATIENT monitor to distribute ALARM
CONDITIONS in a NURSE CALL SYSTEM, and via a PBX with handsets . 34
Figure D.1 – Example hospital-wide DISTRIBUTED ALARM SYSTEM . 36

Table 1 – General comparison of system properties for ALARM CONDITION integration . 18
Table A.1 – Correspondence of the technical RISK CONTROL measures of this technical
report for a CDAS and IEC 60601-1-8 for a DAS . 28

– 4 – IEC TR 80001-2-5:2014 © IEC 2014
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

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

FOREWORD
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example "state of the art".
IEC 80001-2-5, which is a technical report, has been prepared by a joint working group of
subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC
technical committee 62: Electrical equipment in medical practice and ISO technical committee
215: Health informatics.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/943/DTR 62A/955/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 appear in
SMALL CAPITALS.
A list of all parts of the IEC 80001 series, published under the general title Application of risk
management for it-networks incorporating medical devices , can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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