EN 60601-2-57:2011

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

Medizinische elektrische Geräte - Teil 2-57: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten mit Nicht-Laser-Lichtquellen für die Anwendung in der Therapie, Diagnose, Überwachung und für kosmetische/ästhetische Zwecke

Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non-laser prévus pour des utilisations thérapeutiques, de diagnostic, de surveillance et de cosmétique/esthétique

La CEI 60601-2-57:2011 s'applique à la sécurité de base et aux performances essentielles des appareils intégrant une ou plusieurs sources de rayonnement optique dans la gamme des longueurs d'onde de 200 nm à 3 000 nm, à l'exception du rayonnement laser, et prévus pour créer des effets photobiologiques non visibles sur les humains ou sur les animaux, pour applications thérapeutiques, de diagnostic, de surveillance, cosmétiques/esthétiques ou vétérinaires, dénommés ci-après appareils à source de lumière. La CEI 60601-2-57:2011 n'est pas applicable aux appareils de bronzage, aux appareils ophtalmiques ou de photothérapie pour nourrissons. Les appareils à source de lumière peuvent consister en une unique ou en de multiples sources de rayonnement optique, avec ou sans alimentation électrique, ou bien peuvent être intégrés à un système complexe incluant des systèmes optiques, électriques ou mécaniques, ou des sources d'autres rayonnements.

Medicinska električna oprema - 2-57. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme z nelaserskim svetlobnim virom, namenjene za terapevtsko, diagnostično, nadzorovalno in kozmetično/estetsko uporabo (IEC 60601-2-57:2011)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI opreme, ki vključuje enega ali več virov OPTIČNEGA SEVANJA v območju valovnih dolžin med 200 nm in 3000 nm, razen laserskega sevanja, in je namenjena ustvarjanju nevidnih fotobioloških učinkov pri ljudeh in živalih za terapevtsko, diagnostično, nadzorovalno, kozmetično/lepotno ali veterinarsko uporabo; v nadaljevanju oprema s svetlobnim virom (OPREMA SV).
Ta standard ne velja za opremo za sončenje, za oftalmične instrumente ali za fototerapijo dojenčkov.
OPOMBA: Varnostne zahteve v tem standardu so namenjene samo obravnavi NEVARNOSTI za oči in kožo; nevarnosti za notranja tkiva niso vključene v njegovo področje uporabe.
OPREMA SV: je lahko sestavljena iz enega ali več virov OPTIČNEGA SEVANJA, z napajanjem ali brez njega, lahko pa je vgrajena v kompleksen sistem, ki vključuje optične, električne ali mehanske sisteme ali vire drugega sevanja.
OPOMBA: Dodatki od AA do EE so vključeni zaradi podajanja splošnih navodil in prikaza številnih značilnih primerov. Vendar pa dodatki ne morejo veljati za definitivne ali izčrpne.

General Information

• Status: Published
• Publication Date: 07-Apr-2011
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 76 - Optical radiation safety and laser equipment
• Drafting Committee: IEC/TC 76 - IEC_TC_76
• Parallel Committee: IEC/TC 76 - IEC_TC_76
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 26-Oct-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to 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 60601-2-57:2011 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011)

Relations

• Revised: FprEN IEC 60601-2-57:2023 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
• Effective Date: 22-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-57: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten mit Nicht-Laser-Lichtquellen für die Anwendung in der Therapie, Diagnose, Überwachung und für kosmetische/ästhetische Zwecke (IEC 60601-2-57:2011)Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non-laser prévus pour des utilisations thérapeutiques, de diagnostic, de surveillance et de cosmétique/esthétique (CEI 60601-2-57:2011)Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011)11.040.60Terapevtska opremaTherapy equipment11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-57:2011SIST EN 60601-2-57:2011en01-junij-2011SIST EN 60601-2-57:2011SLOVENSKI
STANDARD



SIST EN 60601-2-57:2011



EUROPEAN STANDARD EN 60601-2-57 NORME EUROPÉENNE
EUROPÄISCHE NORM April 2011
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2011 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-57:2011 E
ICS 11.040.50; 11.040.60
English version
Medical electrical equipment -
Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57:2011)
Appareils électromédicaux -
Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non-laser prévus pour des utilisations thérapeutiques, de diagnostic, de surveillance et de cosmétique/esthétique (CEI 60601-2-57:2011)
Medizinische elektrische Geräte -
Teil 2-57: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten mit Nicht-Laser-Lichtquellen für die Anwendung in der Therapie, Diagnose, Überwachung und für kosmetische/ästhetische Zwecke (IEC 60601-2-57:2011)
This European Standard was approved by CENELEC on 2011-03-07. 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, Croatia, 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.
SIST EN 60601-2-57:2011



EN 60601-2-57:2011 - 2 - Foreword The text of document 76/438/FDIS, future edition 1 of IEC 60601-2-57, prepared by IEC TC 76, Optical radiation safety and laser equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-57 on 2011-03-07. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed: – latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop)
2011-12-07 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow)
2014-03-07 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 MDD (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: – Requirements and definitions: roman type. – Test specifications: italic type. – 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 PARTICULAR STAND
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