EN ISO 9703-3:1998

Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998)

This part of ISO 9703 provides guidelines for the application of alarms in equipment intended for use in anaesthesia and respiratory care. Particular device standards take precedence over this part of ISO 9703.

Alarmsignale für Anästhesie und Beatmung - Teil 3: Leitlinien für die Anwendung von Alarmen (ISO 9703-3:1998)

Dieser Teil von ISO 9703 enthält Leitlinien für die Anwendung von Alarmen an Geräten, die zum Einsatz bei Anästhesie und Beatmung vorgesehen sind. Besondere Gerätenormen haben Vorrang gegenüber diesem Teil von ISO 9703.

Signaux d'alarme pour l'anesthésie et les soins respiratoires - Partie 3: Lignes directrices relatives à l'application des alarmes (ISO 9703-3:1998)

Anestezijski alarmi signali in alarmi signali respiratorne oskrbe - 3. del: Navodila za uporabo alarmov (ISO 9703-3:1998)

General Information

• Status: Withdrawn
• Publication Date: 14-Nov-1998
• Withdrawal Date: 02-May-2005
• ICS: 11.040 - Medical equipment
• Technical Committee: CEN/TC 259 - Medical alarms and signals
• Drafting Committee: CEN/TC 259 - Medical alarms and signals
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-May-2005
• Completion Date: 03-May-2005
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 9703-3:2000 - Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9703-3:2000
01-januar-2000
Anestezijski alarmi signali in alarmi signali respiratorne oskrbe - 3. del: Navodila
za uporabo alarmov (ISO 9703-3:1998)
Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of
alarms (ISO 9703-3:1998)
Alarmsignale für Anästhesie und Beatmung - Teil 3: Leitlinien für die Anwendung von
Alarmen (ISO 9703-3:1998)
Signaux d'alarme pour l'anesthésie et les soins respiratoires - Partie 3: Lignes directrices
relatives a l'application des alarmes (ISO 9703-3:1998)
Ta slovenski standard je istoveten z: EN ISO 9703-3:1998
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9703-3:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9703-3:2000

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SIST EN ISO 9703-3:2000

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SIST EN ISO 9703-3:2000

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SIST EN ISO 9703-3:2000
INTERNATIONAL ISO
STANDARD 9703-3
First edition
1998-11-15
Anaesthesia and respiratory care alarm
signals —
Part 3:
Guidance on application of alarms
Signaux d’alarme pour l’anesthésie et les soins respiratoires —
Partie 3: Lignes directrices relatives à l’application des alarmes
A
Reference number
ISO 9703-3:1998(E)

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SIST EN ISO 9703-3:2000
ISO 9703-3:1998(E)
Contents
1 Scope .1
2 Normative references .1
3 Definitions .1
4 Alarm signal characteristics.2
5 Allocation of alarm priorities .2
6 Alarm limits and settings .4
7 Alarm silencing, suspension and inhibition .5
8 Nonlatched alarms.5
9 Latched alarms.6
10 Disabling and inhibiting a monitoring function.6
11 Interface to a remote alarm circuit .6
12 Avoidance of confusion between similar devices.6
13 Information to be provided by the manufacturer of the medical device.6
Annex A  Bibliography .7
©  ISO 1998
All rights reserved. Unless otherwise specified, 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 Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
Printed in Switzerland
ii

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SIST EN ISO 9703-3:2000
© ISO
ISO 9703-3:1998(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 9703-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment.
ISO 9703 consists of the following parts, under the general title Anaesthesia and respiratory care alarm signals:
 Part 1: Visual alarm signals
 Part 2: Auditory alarm signals
 Part 3: Guidance on application of alarms
Annex A of this part of ISO 9703 is for information only.
iii

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SIST EN ISO 9703-3:2000

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SIST EN ISO 9703-3:2000
©
INTERNATIONAL STANDARD  ISO ISO 9703-3:1998(E)
Anaesthesia and respiratory care alarm signals —
Part 3:
Guidance on application of alarms
1 Scope
This part of ISO 9703 provides guidelines for the application of alarms in equipment intended for use in anaesthesia
and respiratory care. Particular device standards take precedence over this part of ISO 9703.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part of
ISO 9703. At the time of publication, the editions indicated were valid. All standards are subject to revision, and
parties to agreements based on this part of ISO 9703 are encouraged to investigate the possibility of applying the
most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid
International Standards.
ISO 9703-1:1992, Anaesthesia and respiratory care alarm signals — Part 1: Visual alarm signals.
ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals.
3 Definitions
For the purposes of this part of ISO 9703, the definitions in ISO 9703-1 and ISO 9703-2 and the following definitions
apply.
3.1
activated
state of a system in which it is capable of performing its intrinsic function
3.2
default alarm settings
alarm settings intrinsic to the system, which are preset by the manufacturer, a user, or an operator and which the
system itself sets, without further intervention, when the alarm system is activated
3.3
disable
inactivate an alarm function
3.4
inhibition
suppression, until revoked intentionally, of alarm signals
3.5
latched alarm
alarm signal for which the visual and auditory components do not stop when the conditions necessary for activation
no longer exist, when limits are restored or when the abnormal patient condition no longer exists
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3.6
nonlatched alarm
alarm signal for which the visual and/or auditory components cease when the conditions necessary for activation no
longer exist
3.7
reset
cause the alarm function to revert to its initial detection state
3.8
silence, verb
mute, verb
cause the cessation and resetting of an auditory alarm by a deliberate action
3.9
suspension
suppression, until revoked automatically, of alarm signals
4 Alarm signal characteristics
The visual and auditory attributes of alarms should comply with ISO 9703-1 and 9703-2.
5 Allocation of alarm priorities
5.1 Principle
The provision of alarms should never be used as a substitute for good design of anaesthesia and respiratory care
devices. ISO 9703-1 and ISO 9703-2 specify the characteristics of auditory and visual alarm signals of high-,
medium- and low-priority alarm signals, but do not specify which priority is allocated to a particular alarm on a
particular device. To allocate a priority to a particular alarm, it is necessary to evaluate the risk to the patient of the
event that the alarm indicates.
The term ‘risk’ is usually associated with the potential harm resulting from the event (level of severity) and the
likelihood of the occurrence of the event (frequency). The concept of ‘risk’ for alarm priority allocation should be
modified by replacing the concept of ‘frequency’ by ‘level of urgency’. (See ISO 14971 and EN 1441 for guidance on
risk analysis of medical devices.)
An event develops over time, either incrementally or suddenly, the latter sometimes being so sudden as to allow
little or no time for even the most competent operator to take action to avoid potentially hazardous consequences to
the patient. IEC 60601-1 requires that the medical device be provided with automatic means to detect and identify
sudden, severe events. Some potentially hazardous conditions develop over a period of time sufficient to allow for
manual remedial actions, and the purpose of the alarm is to attract the operator’s attention to the event and to
indicate the speed of response required.
5.2 Factors to be considered
5.2.1 Level of urgency
The level of urgency of the event should be categorized into the following.
a) Immediate, i.e. having the potential for the event to develop within a period of time not usually sufficient for
manual corrective action.
b) Prompt, i.e. having the potential for the event to develop within a period of time usually sufficient for manual
corrective action.
c) Delayed, i.e. having the potential for the event to develop within an unspecified time greater than that given
under ‘prompt’ in 5.2.1 b).
2

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ISO ISO 9703-3:1998(E)
5.2.2 Level of severity
The level of severity of the event should be categorized into the following, which can also be expressed in a more
generic fashion by the corresponding level of physiological threat (as given in parentheses).
a) Severe, i.e. deat
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