EN 60601-2-57:2011
(Main)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
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.
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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
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.
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 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 7 includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular 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. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. SIST EN 60601-2-57:2011
- 3 - EN 60601-2-57:2011 Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-2-57:2011 was approved by CENELEC as a European Standard without any modification. __________ SIST EN 60601-2-57:2011
(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.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Addition:
Publication Year Title EN/HD Year
IEC 60947-3 - Low-voltage switchgear and controlgear -
Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units EN 60947-3 -
IEC 62471 (mod) - Photobiological safety of lamps and lamp systems EN 62471 -
ISO 3864-2 - Graphical symbols - Safety colours and safety signs -
Part 2: Design principles for product safety labels - -
- 5 - EN 60601-2-57:2011 Annex ZZ (informative)
Coverage of Essential Requirements of EU 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 EU 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 EU Directives may be applicable to the products falling within the scope of this standard. ___________
IEC 60601-2-57 Edition 1.0 2011-01 INTERNATIONAL STANDARD NORME INTERNATIONALE 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
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
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE V ICS 11.040.50; 11.040.60 PRICE CODE CODE PRIX ISBN 978-2-88912-344-5
– 2 – 60601-2-57 IEC:2011
CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards. 8 201.2 Normative references . 10 201.3 Terms and definitions . 10 201.4 General requirements . 13 201.5 General requirements for testing ME EQUIPMENT . 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13 201.7 ME EQUIPMENT identification, marking and documents . 15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20 201.10 Protection against unwanted and excessive radiation HAZARDS . 20 201.11 Protection against excessive temperatures and other HAZARDS . 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21 201.13 HAZARDOUS SITUATIONS and fault conditions . 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Construction of ME EQUIPMENT . 23 201.16 ME SYSTEMS. 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23 Annexes . 23 Annex AA (informative)
Particular guidance and rationale . 24 Annex BB (informative)
Exposure limit values . 26 Annex CC (informative)
Protective eyewear for LS EQUIPMENT . 30 Annex DD (informative)
Summary of MANUFACTURER’S requirements . 31 Annex EE (informative)
Symbols on marking . 32 Bibliography . 33 Index of defined terms used in this particular standard. 34
Figure 201.101 – Example of explanatory label for a device with multiple HAZARD spectral regions . 18 Figure 201.102 – Warning label – HAZARD symbol . 19
Table 201.101 – EMISSION LIMITS for risk groups of LS EQUIPMENT . 14 Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT . 15 Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of accessible emission from LS EQUIPMENT . 15 Table 201.104 – Requirements for labelling of LS EQUIPMENT according to risk group classification . 17 Table BB.1 – EXPOSURE LIMIT values for non-coherent OPTICAL RADIATION . 26 Table BB.2 – S(λ) [dimensionless], 200 nm to 400 nm . 28 Table BB.3 – B (λ), R (λ) [dimensionless], 300 nm to 1 400 nm . 29 SIST EN 60601-2-57:2011
60601-2-57 IEC:2011 – 3 –
Table DD.1 – Summary of MANUFACTURER’S requirements . 31 Table EE.1 – Symbols, references and descriptions . 32
– 4 – 60601-2-57 IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
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
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)
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