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

The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.

Medizinische elektrische Geräte -- Teil 1-8: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen

Appareils électromédicaux -- Partie 1-8: Règles générales de sécurité - Norme collatérale: Règles générales, essais et recommandations pour les systèmes d'alarme des appareils et des systèmes électromédicaux

The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.

Medicinska električna oprema – 1-8. del: Splošne varnostne zahteve – Spremljevalni standard: Splošne zahteve, preskusi in napotki za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih

General Information

Status
Withdrawn
Publication Date
30-Apr-2004
Withdrawal Date
24-Oct-2007
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
24-Oct-2007
Due Date
16-Nov-2007
Completion Date
25-Oct-2007

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EUROPEAN STANDARD EN 60601-1-8
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2004
ICS 11.040.01
English version
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
(IEC 60601-1-8:2003)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 1-8: Règles générales de sécurité - Teil 1-8: Allgemeine Festlegungen
Norme collatérale: Règles générales, für die Sicherheit -
essais et guides pour les systèmes Ergänzungsnorm: Alarmsysteme -
d'alarme dans l'équipement Allgemeine Festlegungen, Prüfungen
électromédical et les systèmes und Richtlinien für Alarmsysteme
électromédicaux in medizinischen elektrischen Geräten
(CEI 60601-1-8:2003) und in medizinischen Systemen
(IEC 60601-1-8:2003)

This European Standard was approved by CENELEC on 2003-12-02. CENELEC members are bound to

comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on

application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CENELEC member into its own language and

notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland

and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-1-8:2004 E
---------------------- Page: 1 ----------------------
EN 60601-1-8:2004 - 2 -
Foreword

The text of document 62A/424/FDIS, future edition 1 of IEC 60601-1-8, prepared by a Joint Working

Group of SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62,

Electrical equipment in medical practice, and SC3, Lung ventilators and related devices, of ISO

TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and

was approved by CENELEC as EN 60601-1-8 on 2003-12-02.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2004-09-01
– latest date by which the national standards conflicting
(dow) 2006-12-01
with the EN have to be withdrawn

This European Standard is a collateral standard to EN 60601-1:1990, hereinafter referred to as the

general standard.

In the 60601 series of publications, collateral standards specify general requirements for safety

applicable to
– a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or

– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general

standard (e.g. alarm systems).

The numbering of sections, clauses and subclauses of this collateral standard corresponds with that of

the general standard.

Clauses, subclauses, tables and figures which are additional to those of the general standard are

numbered starting from 201; additional annexes are lettered AAA, BBB, etc., and additional items

aaa), bbb), etc.
In this collateral standard, the following print types are used:
– requirements and definitions: roman type;

– notes, examples, explanations, advice, introductions, general statements and references: smaller roman type;

– test specifications and guidance in Annex AAA: italic type;

– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED:

SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.

Clauses and subclauses for which a rationale is provided in the informative Annex AAA are marked

with an asterisk (*).
Annex ZA has been added by CENELEC.
__________
Endorsement notice

The text of the International Standard IEC 60601-1-8:2003 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following note has to be added for the standard indicated:

ISO 14971 NOTE Harmonized as EN ISO 14971:2000 (not modified).
__________
---------------------- Page: 2 ----------------------
- 3 - EN 60601-1-8:2004
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.
Publication Year Title EN/HD Year
IEC 60417 database Graphical symbols for use on equipment - -
IEC 60601-1 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1991 A1 1993
+ corr. July 1994
A2 1995 A2 1995
+ corr. June 1995
A13 1996
IEC 60601-1-1 2000 Medical electrical equipment EN 60601-1-1 2001
Part 1-1: General requirements for
safety - Collateral standard: Safety
requirements for medical electrical
systems
IEC 60601-1-6 - Part 1-6: General requirements for - -
safety - Collateral standard: Usability
IEC 60651 1979 Sound level meters EN 60651 1994
A1 1993 A1 1994
A2 2000 A2 2001
ISO 3744 1994 Acoustics - Determination of sound EN ISO 3744 1999
power levels of noise sources using
sound pressure - Engineering method in
an essentially free field over a reflecting
plane
ISO 7000 1989 Graphical symbols for use on equipment - -
- Index and synopsis
To be published.
---------------------- Page: 3 ----------------------
NORME CEI
INTERNATIONALE
IEC
60601-1-8
INTERNATIONAL
Première édition
STANDARD
First edition
2003-08
Appareils électromédicaux –
Partie 1-8:
Règles générales de sécurité – Norme collatérale:
Règles générales, essais et recommandations
pour les systèmes d'alarme des appareils et
des systèmes électromédicaux
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
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved

Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any

utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including

électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from

microfilms, sans l'accord écrit de l'éditeur. 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

CODE PRIX
PRICE CODE
Pour prix, voir catalogue en vigueur
For price, see current catalogue
---------------------- Page: 4 ----------------------
60601-1-8  IEC:2005 – 3 –
CONTENTS

FOREWORD...........................................................................................................................7

INTRODUCTION...................................................................................................................11

SECTION ONE – GENERAL

1 * Scope and object .........................................................................................................13

1.201 Scope ...............................................................................................................13

1.202 Object ...............................................................................................................13

1.203 Relationship to other standards.............................................................................13

1.203.1 IEC 60601-1...................................................................................................13

1.203.2 Particular standards.......................................................................................15

1.203.3 Normative references.....................................................................................15

2 Terminology and definitions............................................................................................15

6 Identification, marking and documents............................................................................23

6.3 Marking of controls and instruments......................................................................23

6.7 Indicator lights and push-buttons ..........................................................................23

6.8.1 ACCOMPANYING DOCUMENTS...............................................................................25

6.8.2 Instructions for use...........................................................................................25

6.8.3 Technical description........................................................................................25

SECTION TWO TO TEN – NOT USED

201 ALARM SYSTEMS............................................................................................................25

201.1 * ALARM CONDITION ................................................................................................25

201.1.1 * General ...................................................................................................25

201.1.2 * ALARM CONDITION priority............................................................................27

201.2 * Disclosures for INTELLIGENT ALARM SYSTEM ..........................................................27

201.3 Generation of ALARM SIGNALS.................................................................................29

201.3.1 General ...................................................................................................29

201.3.2 * Visual ALARM SIGNALS .................................................................................29

201.3.3 * Auditory ALARM SIGNALS..............................................................................31

201.3.4 * Characteristics of verbal ALARM SIGNALS.....................................................37

201.4 * Disclosure of delays ...........................................................................................39

201.4.1 * ALARM SYSTEM delays.................................................................................39

201.4.2 * Delays to or from a DISTRIBUTED ALARM SYSTEM ..........................................39

201.5 ALARM PRESETS .....................................................................................................39

201.5.1 General requirements..............................................................................39

201.5.2 Manufacturer-configured ALARM PRESETS .................................................41

201.5.3 * USER- and OPERATOR-configured ALARM PRESETS ...................................41

201.5.4 DEFAULT ALARM PRESET ............................................................................43

201.5.5 * Interruptions of less than or equal to 30 s .............................................45

201.6 ALARM LIMIT ...........................................................................................................45

201.6.1 General requirements..............................................................................45

201.6.2 * Adjustable ALARM LIMIT ..........................................................................45

201.7 * ALARM SYSTEM security........................................................................................47

201.8 * ALARM SIGNAL inactivation states .........................................................................47

201.8.1 * General.................................................................................................47

201.8.2 * Termination of inactivation of ALARM SIGNALS .........................................49

---------------------- Page: 5 ----------------------
60601-1-8  IEC:2005 – 5 –

201.8.3 * Indication and access............................................................................49

201.9 * ALARM RESET.......................................................................................................51

201.10 * NON-LATCHING and LATCHING ALARM SIGNALS........................................................51

201.11 * DISTRIBUTED ALARM SYSTEM.................................................................................51

201.11.1 * Existence OF DISTRIBUTED ALARM SYSTEM ...............................................51

201.11.2 Requirements for DISTRIBUTED ALARM SYSTEM communication of

ALARM CONDITIONS....................................................................................53

201.12 * ALARM CONDITION logging...................................................................................53

Appendix D (normative) Symbols on marking ........................................................................55

Annex AAA (informative) Rationale and guidance .................................................................65

Annex BBB (informative) Cross-reference of identification, marking, and documents ..........131

Annex CCC (informative) Guidance for auditory ALARM SIGNALS...........................................139

Annex DDD (informative) Verbal ALARM SIGNALS..................................................................141

Annex EEE (normative) Reserved melodies for ALARM SIGNALS............................................147

Bibliography........................................................................................................................149

Index of defined terms ........................................................................................................153

Figure 201 – Illustration of temporal characteristics of auditory ALARM SIGNALS .....................35

Figure AAA.1 – Graphical representation of components of ALARM SYSTEM delay ................101

Table 201 – ALARM CONDITION priorities.................................................................................27

Table 202 – Characteristics of alarm indicator lights .............................................................29

Table 203 – Characteristics of the BURST of auditory ALARM SIGNALS......................................33

Table 204 – Characteristics of the PULSE of auditory ALARM SIGNALS ......................................33

Table 205 – ALARM SIGNAL inactivation states ........................................................................49

Table D.201 – Graphical symbols for ALARM SYSTEMS ............................................................57

Table D.202 – Alternative ALARM SYSTEM related markings ....................................................63

Table AAA.1 – Reference interpretation of Table EEE.1......................................................127

Table AAA.2 – Reference interpretation of Table EEE.2......................................................129

Table BBB.1 – Cross-reference of Marking .........................................................................131

Table BBB.2 – Cross-reference of ACCOMPANYING DOCUMENTS ............................................133

Table BBB.3 – Cross-reference of instructions for use ........................................................135

Table BBB.4 – Cross-reference of technical description......................................................137

Table CCC.1 – Attributes of perceived urgency...................................................................139

Table EEE.1 – Equipment encoded auditory ALARM SIGNALS categorized by ALARM

CONDITION and priority complying with Tables 203 and 204 .................................................147

Table EEE.2 – Auditory LOW PRIORITY ALARM SIGNAL complying with Tables 203 and 204 ....147

---------------------- Page: 6 ----------------------
60601-1-8  IEC:2005 – 7 –
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,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-1-8 has been prepared by a Joint Working Group of IEC

subcommittee 62A: Common aspects of electrical equipment used in medical practice, of

IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee

SC3: Lung ventilators and related devices of ISO technical committee 121: Anaesthetic and

respiratory equipment.
It is published as double logo standard.

This first edition constitutes a collateral standard to IEC 60601-1: Medical electrical

equipment – Part 1: General requirements for safety, hereinafter referred to as the general

standard.
This bilingual version (2005-08) replaces the English version.
---------------------- Page: 7 ----------------------
60601-1-8  IEC:2005 – 9 –
This standard replaces the following standards:

ISO 9703-1 Anesthesia and respiratory care alarm signals – Part 1: Visual alarm signals

ISO 9703-2 Anesthesia and respiratory care alarm signals – Part 2: Auditory alarm signals

ISO 9703-3 Anesthesia and respiratory care alarm signals – Part 3: Guidance on
application of alarms

NOTE This standard is intended to replace other national and regional standards, such as EN 475 Medical

devices – Electrically generated alarm signals.
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/424/FDIS 62A/432/RVD

Full information on the voting for the approval of this standard can be found in the report on

voting indicated in the above table. In ISO, the standard has been approved by 16 P-members

out of 18 having cast a vote.
The French version of this standard has not been voted upon.

In the 60601 series of publications, collateral standards specify general requirements for

safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or

– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the

general standard (e.g. alarm systems).

The numbering of sections, clauses and subclauses of this collateral standard corresponds

with that of the general standard.

Clauses, subclauses, tables, and figures which are additional to those of the general standard

are numbered starting from 201; additional annexes are lettered AAA, BBB, etc., and

additional items aaa), bbb), etc.
In this collateral standard, the following print types are used:
– requirements and definitions: roman type;

– notes, examples, explanations, advice, introductions, general statements and references: smaller roman type;

– test specifications and guidance in Annex AAA: italic type; and

– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS

NOTED: SMALL CAPITALS.
The requirements are followed by specifications for the relevant tests.

Clauses and subclauses for which a rationale is provided in informative Annex AAA are

marked with an asterisk (*).

The committee has decided that the contents of this publication will remain unchanged until

the maintenance result date indicated on the IEC web site 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.
---------------------- Page: 8 ----------------------
60601-1-8  IEC:2005 – 11 –
INTRODUCTION

MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS are increasingly used in

medical practice. ALARM SIGNALS are frequently used to indicate unsatisfactory physiological

PATIENT states, unsatisfactory functional states of the MEDICAL ELECTRICAL EQUIPMENT or

MEDICAL ELECTRICAL SYSTEM or to warn the OPERATOR of potential hazards to the PATIENT or

OPERATOR due to the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM.

INFORMATION SIGNALS convey information that is independent of an ALARM CONDITION.

Surveys of healthcare personnel have indicated significant discontent with ALARM SIGNALS.

Problems include difficulty in identifying the source of an ALARM SIGNAL, loud and distracting

ALARM SIGNALS, and the high incidence of FALSE POSITIVE or NEGATIVE ALARM CONDITIONS [16] .

Surveys of manufacturers of medical monitors demonstrated a wide variety of DEFAULT ALARM

PRESETS. The leading reason for disabling ALARM SIGNALS is the large number of ALARM

SIGNALS associated with FALSE POSITIVE ALARM CONDITIONS. See also bibliography.

Safety of PATIENTS depends on the ability of the OPERATOR to correctly discern the

characteristics of ALARM SIGNALS. Usability is an important element in the design of ALARM

SIGNALS that are readily discernible without being unnecessarily distracting or disturbing. This

approach is intended to rationalize the current situation, to reduce confusion by limiting

proliferation of ALARM SIGNALS and their control states, and to minimize distraction for other

people. This collateral standard was developed with contributions from clinicians, engineers

and applied psychologists.

The terminology, requirements, general recommendations and guidance of this collateral

standard are intended to be useful for manufacturers of MEDICAL ELECTRICAL EQUIPMENT and

MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for particular

standards.

The effectiveness of any ALARM SYSTEM depends critically on its implementation by the USER.

It is important that the USER configure the ALARM SYSTEM so that an OPERATOR is not able to

compromise it.
___________
Figures in brackets refer to the bibliography.
---------------------- Page: 9 ----------------------
60601-1-8  IEC:2005 – 13 –
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
SECTION ONE – GENERAL
1 * Scope and object
1.201 Scope

This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in

MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS.
It also provides guidance for the application of ALARM SYSTEMS.
1.202 Object

The object of this collateral standard is to specify basic safety and essential performance

requirements and tests for ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL

ELECTRICAL SYSTEMS and to provide guidance for their application. This is accomplished by

defining alarm categories (priorities) by degree of urgency, consistent ALARM SIGNALS and

consistent control states and their marking for all ALARM SYSTEMS.

NOTE See IEC 60513:1994 [4] for a description of basic safety and essential performance.

This collateral standard does not specify:

– whether any particular MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM is

required to be provided with ALARM SYSTEMS;
– the particular circumstances which initiate an ALARM CONDITION;
– the allocation of priorities to a particular ALARM CONDITION; or
– the means of generating ALARM SIGNALS.
1.203 Relationship to other standards
1.203.1 IEC 60601-1

For MEDICAL ELECTRICAL EQUIPMENT, this collateral standard complements IEC 60601-1.

When referring to IEC 60601-1 or to this collateral standard, either individually or in

combination, the following conventions are used:
– "the general standard" designates IEC 60601-1 alone;
– "this collateral standard" designates IEC 60601-1-8 alone;

– "this standard" designates the combination of the general standard and this collateral

standard.
---------------------- Page: 10 ----------------------
60601-1-8  IEC:2005 – 15 –
1.203.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in

this collateral standard.
1.203.3 Normative references

The following referenced documents are indispensable for the application of this document.

For dated references, only the edition cited applies. For undated references, the latest edition

of the referenced document (including any amendments) applies.
IEC 60417-DB:2002 , Graphical symbols for use on equipment

IEC 60601-1:1988 Medical electrical equipment – Part 1: General requirements for safety

Amendment 1 (1991)
Amendment 2 (1995)

IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety

– Collateral standard: Safety requirements for medical electrical systems

IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for safety –

Collateral standard: Usability
IEC 60651:1979 , Sound level meters
Amendment 1 (1993)
Amendment 2 (2000)

ISO 3744:1994, Acoustics – Determination of sound power levels of noise sources using

sound pressure – Engineering method in an essentially free field over a reflecting plane

ISO 7000:1989, Graphical symbols for use on equipment – Index and synopsis
2 Terminology and definitions
For the purposes of this collateral standard, the following definitions apply.

NOTE This collateral standard uses the term “equipment” to mean MEDICAL ELECTRICAL EQUIPMENT or non-MEDICAL

ELECTRICAL EQUIPMENT in the context of a MEDICAL ELECTRICAL SYSTEM.
2.201
* ALARM CONDITION

state of the ALARM SYSTEM when it has determined that a potential or actual hazard exists

NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSTIVE ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGAT
...

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