SIST EN 60601-1-8:2008
(Main)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
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
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Standards Content (Sample)
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.
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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).
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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). __________
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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.
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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
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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
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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
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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: General requirements for basic safety and essential performance IEC 60601-1-2:----2), Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests IEC 60601-1-6:---- 3), Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability IEC 60651:1979 4), 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 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1-2:---- 5), IEC 60601-1-6:---- 6), and the following definitions apply. NOTE 1 The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM. NOTE 2 An index of defined terms is found beginning on page 155. ————————— 2)
A second edition of IEC 60601-1-2 exists, published in 2004 under the title Medical electrical equipment – Part 1-2: General requirements for safety – Collateral Standard: Electromagnetic compatibility – Requirements and tests. A third edition under the title given above is currently to be published. References to IEC 60601-1-2 in this standard refer to the new edition. 3)
A first edition of IEC 60601-1-6 exists, published in 2004 under the title Medical electrical equipment – Part 1-6: General requirements for safety – Collateral Standard: Usability. A second edition under the title given above is currently to be published. References to IEC 60601-1-6 in this standard refer to the new edition. 4)
IEC 60651:1979 has been withdrawn and replaced by IEC 61672-1:2002 and IEC 61672-2:2003. Future editions of this publication will be amended to take this fact into account. 5)
To be published. See footnote 2. 6)
To be published. See footnote 3. – 9 –60601-1-8 © IEC:2006
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3.1
* 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 NEGATIVE ALARM CONDITION. 3.2
* ALARM CONDITION DELAY time from the occurrence of a triggering event either in the PATIENT, for PHYSIOLOGICAL ALARM CONDITIONS, or in the equipment, for TECHNICAL ALARM CONDITIONS, to when the ALARM SYSTEM determines that an ALARM CONDITION exists 3.3
* ALARM LIMIT threshold used by an ALARM SYSTEM to determine an ALARM CONDITION 3.4
ALARM OFF state of indefinite duration in which an ALARM SYSTEM or part of an ALARM SYSTEM does not generate ALARM SIGNALS 3.5
* ALARM PAUSED state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate ALARM SIGNALS 3.6
ALARM PRESET set of stored configuration parameters, including selection of algorithms and initial values for use by algorithms, which affect or modify the performance of the ALARM SYSTEM 3.7
ALARM RESET OPERATOR action that causes the cessation of an ALARM SIGNAL for which no associated ALARM CONDITION currently exists 3.8
ALARM SETTINGS ALARM SYSTEM configuration, including but not limited to: – ALARM LIMITS; – the characteristics of any ALARM SIGNAL inactivation states; and – the values of variables or parameters that determine the function of the ALARM SYSTEM NOTE
Some algorithmically-determined ALARM SETTINGS can require time to be determined or re-determined. 3.9
ALARM SIGNAL type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION 60601-1-8 © IEC:2006– 10 –
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3.10
* ALARM SIGNAL GENERATION DELAY time from the onset of an ALARM CONDITION to the generation of its ALARM SIGNAL(S) 3.11
ALARM SYSTEM
parts of ME EQUIPMENT or a ME SYSTEM that detect ALARM CONDITIONS and, as appropriate, generate ALARM SIGNALS 3.12
AUDIO OFF state of indefinite duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL 3.13
AUDIO PAUSED state of limited duration in which the ALARM SYSTEM or part of the ALARM SYSTEM does not generate an auditory ALARM SIGNAL 3.14
BURST group of PULSES with a distinctive rhythm or pattern 3.15
DE-ESCALATION PROCESS by which an ALARM SYSTEM decreases the priority of an ALARM CONDITION or decreases the sense of urgency of an ALARM SIGNAL 3.16
DEFAULT ALARM PRESET ALARM PRESET that can be activated by the ALARM SYSTEM without OPERATOR action NOTE MANUFACTURER- or RESPONSIBLE ORGANIZATION-configured ALARM PRESETS are possible types of DEFAULT ALARM PRESETS. 3.17
* DISTRIBUTED ALARM SYSTEM ALARM SYSTEM that involves more than one item of equipment of a ME SYSTEM NOTE
The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.
3.18
ESCALATION PROCESS by which an ALARM SYSTEM increases the priority of an ALARM CONDITION or increases the sense of urgency of an ALARM SIGNAL 3.19
FALL TIME
tf interval over which the PULSE amplitude decreases from 90 % to 10 % of its maximum (see Figure 1) 3.20
FALSE NEGATIVE ALARM CONDITION absence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM – 11 –60601-1-8 © IEC:2006
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NOTE
An ALARM CONDITION can be rejected or missed because of spurious information produced by the PATIENT, the PATIENT-equipment interface, other equipment or the equipment itself. 3.21
FALSE POSITIVE ALARM CONDITION presence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the equipment or the ALARM SYSTEM NOTE
A FALSE POSITIVE ALARM CONDITION can be caused by spurious information produced by the PATIENT, the PATIENT-equipment interface, other equipment or the ALARM SYSTEM itself. 3.22
HIGH PRIORITY indicating that immediate OPERATOR response is required NOTE
The priority is assigned through RISK ANALYSIS. 3.23
* INFORMATION SIGNAL any signal that is not an ALARM SIGNAL or a REMINDER SIGNAL EXAMPLE 1 ECG waveform EXAMPLE 2 SpO2 tone EXAMPLE 3 Fluoroscopy beam-on indication 3.24
* INTELLIGENT ALARM SYSTEM ALARM SYSTEM that makes logical decisions based on monitored information without OPERATOR intervention EXAMPLE 1 An ALARM SYSTEM that changes priority based on the rate of change of a monitored variable.
EXAMPLE 2 An ALARM SYSTEM that suppresses an ALARM CONDITION when a related ALARM CONDITION of higher priority has recently generated an ALARM SIGNAL. 3.25
INTERBURST INTERVAL tb period of time between the end of the last PULSE of a BURST and the start of the first PULSE of the next BURST of the same ALARM SIGNAL (see Figure 1) 3.26
LATCHING ALARM SIGNAL ALARM SIGNAL that continues to be generated after its triggering event no longer exists until stopped by deliberate OPERATOR action 3.27
LOW PRIORITY indicating that OPERATOR awareness is required NOTE
The priority is assigned through RISK ANALYSIS. 3.28
MEDIUM PRIORITY indicating that prompt OPERATOR response is required NOTE The priority is assigned through RISK ANALYSIS. 3.29
NON-LATCHING ALARM SIGNAL ALARM SIGNAL that automatically stops being generated when its associated triggering event no longer exists 60601-1-8 © IEC:2006– 12 –
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3.30
OPERATOR'S POSITION intended position of the OPERATOR with respect to the ALARM SIGNAL generating part of the ALARM SYSTEM NOTE A DISTRIBUTED ALARM SYSTEM can have multiple OPERATOR’S POSITIONS. 3.31
PHYSIOLOGICAL ALARM CONDITION ALARM CONDITION arising from a monitored PATIENT-related variable EXAMPLE 1 High exhaled anesthetic agent concentration. EXAMPLE 2 Low exhaled tidal volume. EXAMPLE 3 Low oxygen saturation measured by pulse oximetry. EXAMPLE 4 High arterial pressure. EXAMPLE 5 High heart rate. 3.32
PULSE brief continuous sound having a specific spectral content 3.33
PULSE FREQUENCY
fo fundamental frequency (first harmonic) of a PULSE 3.34
* REMINDER SIGNAL periodic signal that reminds the OPERATOR that the ALARM SYSTEM is in an ALARM SIGNAL-inactivation state 3.35
RISE TIME tr interval over which the PULSE increases from 10% to 90% of its maximum amplitude (see Figure 1) 3.36
TECHNICAL ALARM CONDITION ALARM CONDITION arising from a monitored equipment-related or ALARM SYSTEM-related variable EXAMPLE 1 An electrical, mechanical or other failure. EXAMPLE 2 A failure of a sensor or component (unsafe voltage, high impedance, signal impedance, artifact, noisy signal, disconnection, calibration error, tubing obstruction, etc.). EXAMPLE 3 An algorithm that cannot classify or resolve the available data. 4 General requirements If the MANUFACTURER chooses as a means of RISK CONTROL to have the ME EQUIPMENT or ME SYSTEM notify the OPERATOR that a HAZARDOUS SITUATION can exist, then the ME EQUIPMENT or ME SYSTEM shall include an ALARM SYSTEM complying with this collateral standard for that purpose. See also 12.3 of the general standard. The RISK ASSESSMENT shall also consider HAZARDS to PATIENTS, OPERATORS, and other persons arising from the ALARM SYSTEM (see 6.8.3). – 13 –60601-1-8 © IEC:2006
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5 ME EQUIPMENT identification marking and documents NOTE Additional requirements for the marking on controls and instruments are specified in this collateral standard, together with the technical requirements, giving rise to requirements on markings. These requirements are also listed in Annex B. 5.1 Indicator lights and controls In addition to the requirements for colours of indicator lights and their meanings in 7.8.1 of the general standard, the requirements of 6.3.2.2 apply. NOTE Dot matrix or other alphanumeric displays are not considered to be an alarm indicator light unless those displays are used to simulate an alarm indicator lights (see 6.3.2.2). 5.2 ACCOMPANYING DOCUMENTS NOTE Additional requirements on ACCOMPANYING DOCUMENTS are specified in this collateral standard, together with the technical requirements, giving rise to requirements on ACCOMPANYING DOCUMENTS. These requirements are also listed in Table B.2. 5.2.1 Instructions for use The instructions for use shall: • * provide an overview of the ALARM SYSTEM, including a listing and description of every possible ALARM CONDITION and, as appropriate for the intended OPERATOR, a summary of how it is determined; • indicate any delay inherent in the determination of an ALARM CONDITION; • disclose the OPERATOR'S POSITION; and • * include how and when to verify the functionality of the ALARM SYSTEM. As applicable, the instructions for use shall caution against setting ALARM LIMITS to extreme values that can render the ALARM SYSTEM useless. NOTE Additional requirements on instructions for use are specified in this collateral standard, together with the technical requirements, giving rise to requirements on instructions for use. These requirements are also listed in Table B.3. Compliance is checked by inspection of the instructions for use. 5.2.2 Technical description NOTE
Additional requirements on technical description are specified in this collateral standard, together with the technical requirements, giving rise to requirements on technical description. These requirements are also listed in Table B.4. 6 ALARM SYSTEMS 6.1 ALARM CONDITION 6.1.1 * General If ALARM CONDITIONS are grouped into PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS or other ALARM CONDITION groups by the MANUFACTURER, this shall be disclosed in the instructions for use. Compliance is checked by inspection of the instructions for use. 60601-1-8 © IEC:2006– 14 –
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6.1.2 * ALARM CONDITION priority ALARM CONDITIONS shall be assigned to one or more of the following priorities: HIGH PRIORITY, MEDIUM PRIORITY, or LOW PRIORITY. Unless a particular ALARM CONDITION priority is specified in a relevant particular standard, the assignment of priorities is part of the RISK MANAGEMENT PROCESS and shall be based on Table 1. The priority of each ALARM CONDITION shall be disclosed in the instructions for use. Priorities may be identified in groups. Compliance is checked by inspection of the instructions for use and RISK MANAGEMENT FILE. Table 1 – ALARM CONDITION priorities Onset of potential HARM a Potential result of failure to respond to the cause of ALARM CONDITION Immediate b Prompt c Delayed d Death or irreversible injury HIGH PRIORITY e
HIGH PRIORITY MEDIUM PRIORITY Reversible injury HIGH PRIORITY MEDIUM PRIORITY LOW PRIORITY Minor injury or discomfort MEDIUM PRIORITY LOW PRIORITY LOW PRIORITY
or no ALARM SIGNAL
An INFORMATION SIGNAL may also be used to indicate the potential for delayed minor injury or discomfort.
a Onset of potential HARM refers to when an injury occurs and not to when it is manifested. b Having the potential for the event to develop within a period of time not usually sufficient for manual corrective action. c Having the potential for the event to develop within a period of time usually sufficient for manual corrective action. d Having the potential for the event to develop within an unspecified time greater than that given under “prompt”. e Where practicable, ME EQUIPMENT with a therapeutic function incorporates automatic safety mechanisms to prevent immediate death or irreversible injury caused by the ME EQUIPMENT.
See also appropriate particular standards. 6.2 * Disclosures for INTELLIGENT ALARM SYSTEM If an INTELLIGENT ALARM SYSTEM is provided, the instructions for use shall include, as applicable, an overview of how the ALARM SYSTEM:
a) determines an ALARM CONDITION on the basis of time, weightings, multiple variables, or other advanced processing (including, but not limited to, algorithms, neural networks, fuzzy logic, etc.); b) generates ALARM SIGNALS for two or more ALARM CONDITIONS of equal priority (including, but not limited to, internal ranking, effect on generation of ALARM SIGNALS); c) changes the previously-assigned priority or relative prioritization of a particular ALARM CONDITION (e.g., ESCALATION or DE-ESCALATION); d) changes the ALARM SIGNAL GENERATION DELAY or ALARM CONDITION DELAY; and e) changes the characteristics of the generated ALARM SIGNALS (for example, volume, pitch, tempo, urgency). Compliance is checked by inspection of the instructions for use. – 15 –60601-1-8 © IEC:2006
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6.3 Generation of ALARM SIGNALS 6.3.1 General Each ALARM CONDITION shall cause the generation of visual ALARM SIGNALS as specified in this collateral standard. If deemed necessary by RISK ASSESSMENT regarding the environment in which the ALARM SYSTEM is intended to be used, additional ALARM SIGNALS shall
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