IEC 60601-1-8:2003

INTERNATIONAL IEC
STANDARD
60601-1-8
First edition
2003-08
Medical electrical equipment –
Part 1-8:
General requirements for safety –
Collateral standard:
General requirements, tests and guidance
for alarm systems in medical electrical
equipment and medical electrical systems
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité –
Norme collatérale:
Règles générales, essais et guides
pour les systèmes d'alarme dans l'équipement
électromédical et les systèmes électromédicaux

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INTERNATIONAL IEC
STANDARD
60601-1-8
First edition
2003-08
Medical electrical equipment –
Part 1-8:
General requirements for safety –
Collateral standard:
General requirements, tests and guidance
for alarm systems in medical electrical
equipment and medical electrical systems
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité –
Norme collatérale:
Règles générales, essais et guides
pour les systèmes d'alarme dans l'équipement
électromédical et les systèmes électromédicaux

 IEC 2003  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch  Web: www.iec.ch
PRICE CODE
XB
For price, see current catalogue

– 2 – 60601-1-8  IEC:2003(E)
CONTENTS
FOREWORD . 4

INTRODUCTION .6

SECTION ONE – GENERAL
1 Scope and object . 7

1.201 Scope . 7

1.202 Object . 8

1.203 Relationship to other standards. 7
1.203.1 IEC 60601-1 . 7
1.203.2 Particular standards . 7
1.203.3 Normative references . 8
2 Terminology and definitions . 8
6 Identification, marking and documents .12
6.3 Marking of controls and instruments .12
6.7 Indicator lights and push-buttons.12
6.8.1 ACCOMPANYING DOCUMENTS .12
6.8.2 Instructions for use .12
6.8.3 Technical description.13
SECTION TWO TO TEN – NOT USED
201 ALARM SYSTEMS .13
201.1 ALARM CONDITION .13
201.1.1 General .13
201.1.2 ALARM CONDITION priority .13
201.2 Disclosures for INTELLIGENT ALARM SYSTEM.14
201.3 Generation of ALARM SIGNALS .14
201.3.1 General .14
201.3.2 Visual ALARM SIGNALS .14
201.3.3 Auditory ALARM SIGNALS .15
201.3.4 Characteristics of verbal ALARM SIGNALS .18
201.4 Disclosure of delays .18
201.4.1 ALARM SYSTEM delays .18

201.4.2 Delays to or from a DISTRIBUTED ALARM SYSTEM.19
201.5 ALARM PRESETS.19
201.5.1 General requirements .19
201.5.2 Manufacturer-configured ALARM PRESETS.20
201.5.3 USER- and OPERATOR-configured ALARM PRESETS.20
201.5.4 DEFAULT ALARM PRESET .21
201.5.5 Interruptions of less than or equal to 30 s .21
201.6 ALARM LIMIT.22
201.6.1 General requirements .22
201.6.2 Adjustable ALARM LIMIT .22
201.7 ALARM SYSTEM security .22
201.8 ALARM SIGNAL inactivation states .23
201.8.1 General .23
201.8.2 Termination of inactivation of ALARM SIGNALS.23

60601-1-8  IEC:2003(E) – 3 –
201.8.3 Indication and access .23

201.9 ALARM RESET .24

201.10 NON-LATCHING and LATCHING ALARM SIGNALS .24

201.11 DISTRIBUTED ALARM SYSTEM .25

201.11.1 Existence OF DISTRIBUTED ALARM SYSTEM .25

201.11.2 Requirements for DISTRIBUTED ALARM SYSTEM communication of

ALARM CONDITIONS .25

201.12 ALARM CONDITION logging.26

Appendix D (normative) Symbols on marking .27
Annex AAA (informative) Rationale and guidance.32
Annex BBB (informative) Cross-reference of identification, marking, and documents.61
Annex CCC (informative) Guidance for auditory ALARM SIGNALS.64
Annex DDD (informative) Verbal ALARM SIGNALS .65
Annex EEE (normative) Reserved melodies for ALARM SIGNALS.67
Bibliography.68
Index of defined terms.70
Figure 201 – Illustration of temporal characteristics of auditory ALARM SIGNALS.17
Figure AAA.1 – Graphical representation of components of ALARM SYSTEM delay.48
Table 201 – ALARM CONDITION priorities .13
Table 202 – Characteristics of alarm indicator lights .15
Table 203 – Characteristics of the BURST of auditory ALARM SIGNALS .16
Table 204 – Characteristics of the PULSE of auditory ALARM SIGNALS .16
Table 205 – ALARM SIGNAL inactivation states.24
Table D.201 – Graphical symbols for ALARM SYSTEMS .28
Table D.202 – Alternative ALARM SYSTEM related markings .31
Table AAA.1 – Reference interpretation of Table EEE.1 .60
Table AAA.2 – Reference interpretation of Table EEE.2 .60
Table BBB.1 – Cross-reference of Marking.61

Table BBB.2 – Cross-reference of ACCOMPANYING DOCUMENTS.62
Table BBB.3 – Cross-reference of instructions for use .63
Table BBB.4 – Cross-reference of technical description .63
Table CCC.1 – Attributes of perceived urgency .64
Table EEE.1 – Equipment encoded auditory ALARM SIGNALS categorized by ALARM
CONDITION and priority complying with Tables 203 and 204.67
Table EEE.2 – Auditory LOW PRIORITY ALARM SIGNAL complying with Tables 203 and 204.67

– 4 – 60601-1-8  IEC:2003(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-8: General requirements for safety –

Collateral Standard:
General requirements, tests and guidance for alarm systems

in medical electrical equipment and medical electrical systems

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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(ISO) in accordance with conditions determined by agreement between the two organizations.
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consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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5) IEC provides no marking procedure
...