EN 60601-1-8:2007

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
• Withdrawal Date: 31-May-2012
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 31-Jul-2007
• Completion Date: 31-Jul-2007
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1-8:2008 - 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

Relations

• Replaces: EN 60601-1-8:2004/A1:2006 - 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
• Effective Date: 28-Jan-2023
• Replaces: EN 60601-1-8:2004 - 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
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-1-8:2007/A1:2013 - 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
• Effective Date: 29-Jan-2023
• Amended By: EN 60601-1-8:2007/A2:2021 - 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
• Effective Date: 26-Jan-2023
• Amended By: EN 60601-1-8:2007/A11:2017 - 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
• Effective Date: 24-Jan-2017

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.



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.
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