EN 60601-1-8:2007

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
Bibliogra
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