Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Specifies 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 einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen

Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux

Spécifie les exigences de sécurité de base et les exigences en matière de performances essentielles ainsi que les essais des systèmes d'alarme des appareils et des systèmes électromédicaux et de donner des lignes directrices pour leur application. Cela est réalisé en définissant des catégories d'alarmes (priorités) par degré d'urgence, des signaux d'alarme et des états de commande cohérents et leur marquage pour tous les systèmes d'alarme.

Medicinska električna oprema - 1-8. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Splošne zahteve, preskušanje in napotki za alarmne sisteme v medicinski električni opremi in medicinskih električnih sistemih (IEC 60601-1-8:2006)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEM). Ta spremljevalni standard določa zahteve za ALARMNE SISTEME in ALARMNE SIGNALE v ELEKTROMEDICINSKI OPREMI in ELEKTROMEDICINSKIH SISTEMIH. Podaja tudi smernice za primere uporabe ALARMNIH SISTEMOV.

General Information

Status
Published
Publication Date
30-Jul-2007
Current Stage
6060 - Document made available
Due Date
31-Jul-2007
Completion Date
31-Jul-2007

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006)WHYHAppareils lectromdicaux - Partie 1-8: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale: Exigences gnrales, essais et guide pour les systmes d'alarme des appareils et des systmes lectromdicaux (IEC 60601-1-8:2006)Medizinische elektrische Gerte - Teil 1-8: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Alarmsysteme - Allgemeine Festlegungen, Prfungen und Richtlinien fr Alarmsysteme in medizinischen elektrischen Gerten und in medizinischen elektrischen Systemen (IEC 60601-1-8:2006)Ta slovenski standard je istoveten z:EN 60601-1-8:2007SIST EN 60601-1-8:2008en,fr,de11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:SIST EN 60601-1-8:20041DGRPHãþDSLOVENSKI

STANDARDSIST EN 60601-1-8:200801-januar-2008
EUROPEAN STANDARD EN 60601-1-8 NORME EUROPÉENNE
EUROPÄISCHE NORM July 2007

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
© 2007 CENELEC -

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

Ref. No. EN 60601-1-8:2007 E
ICS 11.040.01 Supersedes EN 60601-1-8:2004 + A1:2006 English version
Medical electrical equipment -
Part 1-8: General requirements
for basic safety and essential performance -
Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment
and medical electrical systems (IEC 60601-1-8:2006)
Appareils électromédicaux -
Partie 1-8: Exigences générales
pour la sécurité de base
et les performances essentielles -

Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils

et des systèmes électromédicaux (CEI 60601-1-8:2006)
Medizinische elektrische Geräte -
Teil 1-8: Allgemeine Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale -
Ergänzungsnorm: Alarmsysteme -
Allgemeine Festlegungen, Prüfungen
und Richtlinien für Alarmsysteme
in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen
(IEC 60601-1-8:2006)

This European Standard was approved by CENELEC on 2007-04-11. 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, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

EN 60601-1-8:2007
- 2 -

Foreword The text of document 62A/519/CDV, future edition 2 of IEC 60601-1-8, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, and ISO SC 3, Lung ventilators and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved by CENELEC as EN 60601-1-8 on 2007-04-11. The following date was 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)

2008-02-01 This European Standard supersedes EN 60601-1-8:2004 and its amendment A1:2006

(+ corrigendum October 2006). However, EN 60601-1-8:2004 remains valid until all the parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national standards (dow) has therefore been fixed. However, when Part 1-8 is used for appliances not covered by a part 2, EN 60601-1-8:2004 is not to be used after 2009-09-12. This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. This EN 60601-1-8 was revised to structurally align it with EN 60601-1:2006 and to implement the decision of IEC SC 62A that the clause numbering structure of collateral standards written to EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in EN 60601-1:2006. 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). In this collateral standard the following print types are used: − requirements and definitions: in roman type; − test specifications: in italic type. In addition, in Annex A text in italics indicates guidance that describes means to achieve the safety objectives of this collateral standard; − informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; − TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTES: IN SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the six numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.); –

“subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are all subclauses of Clause 6).

- 3 - EN 60601-1-8:2007

References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb − “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; − “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; − “may” is used to describe a permissible way to achieve compliance with a requirement or test. Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-1-8:2006 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/IEC 14971 NOTE Harmonized as EN ISO 14971:2000 (not modified). __________

EN 60601-1-8:2007
- 4 -
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 Data base Graphical symbols for use on equipment - -

IEC 60601-1
2005 Medical electrical equipment -

Part 1: General requirements for basic safety and essential performance EN 60601-1 2006

IEC 60601-1-2 (mod) 2007 Medical electrical equipment -

Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007

IEC 60601-1-6 2006 Medical electrical equipment -

Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 2007

IEC 60651 A1 A2 1979 1993 2000 Sound level meters EN 60651 1) A1 A2
1994 1994 2001

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 EN ISO 3744 1995

ISO 7000 1989 Graphical symbols for use on equipment - Index and synopsis - -

1) EN 60651 + A1 + A2 are superseded by EN 61672-1:2003 & EN 61672-2:2003, which are based on

IEC 61672-1:2002 & IEC 61672-2:2003.
- 5 - EN 60601-1-8:2007
Annex ZZ (informative)

Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. ___________

IEC 60601-1-8Edition 2.0 2006-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment –

Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Appareils électromédicaux –

Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles – Norme collatérale: Exigences générales, essais et guide pour

les systèmes d’alarme des appareils et des systèmes électromédicaux

INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XCICS 11.040.01 PRICE CODECODE PRIXISBN 2-8318-8826-3

60601-1-8 © IEC:2006 – 3 –

CONTENTS FOREWORD...........................................................................................................................4 INTRODUCTION....................................................................................................................7

1 * Scope, object and related standards .............................................................................8 1.1 Scope.....................................................................................................................8 1.2 Object ....................................................................................................................8 1.3 Related standards ..................................................................................................8 2 Normative references ......................................................................................................9 3 Terms and definitions ......................................................................................................9 4 General requirements.....................................................................................................13 5 ME EQUIPMENT identification marking and documents......................................................14 5.1 Indicator lights and controls...................................................................................14 5.2 ACCOMPANYING DOCUMENTS....................................................................................14 6 ALARM SYSTEMS...............................................................................................................14 6.1 ALARM CONDITION ...................................................................................................14 6.2 * Disclosures for INTELLIGENT ALARM SYSTEM ..........................................................15 6.3 Generation of ALARM SIGNALS .................................................................................16 6.4 * Disclosure of delays............................................................................................21 6.5 ALARM PRESETS......................................................................................................21 6.6 ALARM LIMIT ...........................................................................................................24 6.7 * ALARM SYSTEM security........................................................................................25 6.8 * ALARM SIGNAL inactivation states .........................................................................25 6.9 * ALARM RESET .......................................................................................................27 6.10 * NON-LATCHING and LATCHING ALARM SIGNALS ........................................................27 6.11 * DISTRIBUTED ALARM SYSTEM .................................................................................28 6.12 * ALARM CONDITION logging ....................................................................................29

Annex A (informative)

General guidance and rationale........................................................30 Annex B (informative)

Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS..................................................................................................................64 Annex C (normative)

Symbols on marking..........................................................................67 ANNEX D (informative)

Guidance for auditory ALARM SIGNALS ..............................................71 ANNEX E (informative)

Verbal ALARM SIGNALS......................................................................72 ANNEX F (normative)

* Reserved melodies for ALARM SIGNALS.............................................75

Bibliography........................................................................................................................76

Index of defined terms used in this collateral standard........................................................78

Figure 1 – Illustration of temporal characteristics of auditory ALARM SIGNALS ........................19 Figure A.1 – Graphical representation of components of ALARM SYSTEM delay......................49

– 2 –60601-1-8 © IEC:2006
60601-1-8 © IEC:2006 – 5 –

Table 1 – ALARM CONDITION priorities.....................................................................................15 Table 2 – Characteristics of alarm indicator lights.................................................................16 Table 3 – * Characteristics of the BURST of auditory ALARM SIGNALS .......................................18 Table 4 – * Characteristics of the PULSE of auditory ALARM SIGNALS........................................18 Table 5 – ALARM SIGNAL inactivation states............................................................................27 Table A.1 – Reference interpretation of Table F.1................................................................62 Table A.2 – Reference interpretation of Table F.2................................................................63 Table B.1 – Cross-reference of marking...............................................................................64 Table B.2 – Cross-reference of ACCOMPANYING DOCUMENTS ..................................................65 Table B.3 – Cross-reference of instructions for use..............................................................65 Table B.4 – Cross-reference of technical description ...........................................................66 Table C.1 – Graphical symbols for ALARM SYSTEMS ...............................................................67 Table C.2 – Alternative ALARM SYSTEM related markings.......................................................70 Table D.1 – Attributes of perceived urgency.........................................................................71 Table F.1 – * Equipment encoded auditory ALARM SIGNALS categorized by ALARM CONDITION and priority complying with Table 3 and Table 4..................................................75 Table F.2 – * Auditory LOW PRIORITY ALARM SIGNAL complying with Table 3 and Table 4 .......75

60601-1-8 © IEC:2006– 3 –
60601-1-8 © IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-8: General requirements for basic safety

and essential performance – 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 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 SC 3: Lung ventilators and related devices of ISO technical committee 121: Anaesthetic and respiratory equipment. It is published as double logo standard. IEC 60601-1-8 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment – Part 1: General requirements for safety and essential performance hereafter referred to as the general standard. 60601-1-8 © IEC:2006– 4 –

60601-1-8 © IEC:2006 – 9 –

This second edition cancels and replaces the first edition of IEC 60601-1-8, published in 2003, of which it constitutes a technical revision. This edition of IEC 60601-1-8 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC Subcommittee 62 A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004.

The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005. The text of this collateral standard is based on the following documents: CDV Report on voting 62A/519/CDV 62A/537A/RVC

Full information on the voting for the approval of this collateral standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 18 P-members out of 18 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 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). In this collateral standard, the following print types are used: – Requirements and definitions: roman type. – Test specifications: italic type. In addition, in Annex A text in italics indicates guidance that describes means to achieve the safety objectives of this collateral standard. – Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.3.1 are all subclauses of Clause 6). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. – 5 –60601-1-8 © IEC:2006

60601-1-8 © IEC:2006 – 11 –

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: − “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; − “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; − “may” is used to describe a permissible way to achieve compliance with a requirement or test. Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). A list of all parts of the IEC 60601 series, under the general title: Medical electrical equipment, can be found on the IEC website. The committee has decided that the contents of this collateral standard 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 60601-1-8 © IEC:2006– 6 –

60601-1-8 © IEC:2006 – 13 –

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 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] 1). 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 RESPONSIBLE ORGANIZATION. It is important that the RESPONSIBLE ORGANIZATION configure the ALARM SYSTEM so that an OPERATOR is not able to compromise it. ————————— 1) Figures in brackets refer to the bibliography. – 7 –60601-1-8 © IEC:2006

60601-1-8 © IEC:2006 – 15 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-8: General requirements for basic safety

and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

1 * Scope, object and related standards 1.1 Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS. 1.2 Object The object of this collateral standard is to specify basic safety and essential performance requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME 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. This collateral standard does not specify: – whether any particular ME EQUIPMENT or ME 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. 1.3 Related standards 1.3.1 IEC 60601-1 For ME EQUIPMENT and ME SYSTEMS, 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. 60601-1-8 © IEC:2006– 8 –

60601-1-8 © IEC:2006 – 17 –

1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard. 2 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, Graphical symbols for use on equipment

IEC 60601-1:2005, Medical electrical equipment – Part 1: Gen
...

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