SIST EN 60601-2-57:2011

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
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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

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Table DD.1 – Summary of MANUFACTURER’S requirements . 31 Table EE.1 – Symbols, references and descriptions . 32
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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)”). 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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 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 60601-2-57 has been prepared by IEC technical committee TC 76: Optical radiation safety and laser equipment The text of this standard is based on the following documents: FDIS Report on voting 76/438/FDIS 76/441/RVD
Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: SIST EN 60601-2-57:2011

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– 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. A list of all parts of the IEC 60601 series, published under the general title: Medical electrical equipment can be found on the IEC website. SIST EN 60601-2-57:2011

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The committee has decided that the contents of this publication will remain unchanged until the stability 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.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer.
60601-2-57  IEC:2011 – 7 –
INTRODUCTION This particular standard amends and supplements IEC 60601-1:2005 (third edition): Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance. The requirements of this particular standard should be taken as the minimum to comply with, in order to achieve a reasonable level of safety and reliability during operation and application of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. An asterisk (*) notes clauses for which there is rationale comment in Annex AA. It is considered that knowledge of the reasons for these requirements will facilitate the proper application of this particular standard and be of use in any revision that may be necessitated by changes in clinical practice or as a result of developments in technology. SIST EN 60601-2-57:2011

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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
201.1 Scope, object and related standards Clause 1 of the general standard1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard 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 (LS EQUIPMENT).
This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope. LS 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, electrical or mechanical systems or sources of other radiation. NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitive or exhaustive. 201.1.2 Object Replacement: The objects of this particular standard are:
– to establish optical radiation safety, basic safety and essential performance requirements for LS EQUIPMENT; – to specify requirements for the MANUFACTURER to supply information and establish procedures so that proper precautions can be adopted; – to provide warning to individuals of HAZARDS associated with accessible OPTICAL RADIATION from LS EQUIPMENT through signs, labels and instructions; – to reduce the possibility of injury by minimizing unnecessary accessible OPTICAL RADIATION; to provide means of improved control of the HAZARDS related to OPTICAL RADIATION through protective features and to assist safe use of LS EQUIPMENT; ___________ 1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. SIST EN 60601-2-57:2011

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– to protect persons against other HAZARDS resulting from the operation and use of LS EQUIPMENT. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and in Clause 201.2 of this particular standard. All published collateral standards in the IEC 60601 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other basic safety and essential performance requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this particular standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: "Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. "Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this particular standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. SIST EN 60601-2-57:2011

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Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard. 201.2 Normative references NOTE Informative references are listed in the Bibliography on page 33. Clause 2 of the general standard applies, except as follows: Addition: IEC 60947-3, Low voltage switchgear and controlgear – Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units IEC 62471, Photobiological safety of lamps and lamp systems
ISO 3864-2, Graphical symbols – Safety colours and safety signs – Part 2: Design principles for product safety labels. 201.3 Terms and definitions NOTE An index of defined terms used in this document is found beginning on page 34. For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, apply, except as follows: Replacement: 201.3.18 CONTINUOUS OPERATION operation with a continuous OPTICAL RADIATION output for a duration equal to or greater than 0,25 s for wavelengths in the range 400 to 700 nm and 10 s for all other wavelengths Addition: 201.3.201 ANGLE OF ACCEPTANCE
γ plane angle within which a detector responds to OPTICAL RADIATION
NOTE 1 THE ANGLE OF ACCEPTANCE may be controlled by apertures or optical elements.
NOTE 2 The ANGLE OF ACCEPTANCE is sometimes referred to as the field-of-view. SI Unit: radian (rad) 201.3.202 ANGULAR SUBTENSE
α visual angle subtended by the source or apparent source at the eye of an observer or at the point of measurement
NOTE In this particular standard subtended angles are denoted by the full included angle, not the half angle. SIST EN 60601-2-57:2011

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SI Unit: radian (rad) 201.3.203 EMERGENCY STOP device intended to stop the LS EQUIPMENT OUTPUT immediately in case of emergency 201.3.204 EMISSION APERTURE opening or window through which the OPTICAL RADIATION is emitted 201.3.205 EMISSION LIMIT maximum accessible emission permitted for a particular risk group
201.3.206 EXPOSURE LIMIT maximum level of exposure of the eye or skin that is not expected to result in adverse biological effects NOTE EXPOSURE LIMITS are shown in Table BB.1 201.3.207 EXPOSURE TIME PULSE DURATION (for a single pulse), duration of a pulse train or of a continuous emission of optical radiation incident upon the human or animal body during operation, maintenance or servicing of LS EQUIPMENT SI Unit: second (s)
201.3.208 LS EQUIPMENT ME EQUIPMENT which incorporates one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and which is intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications 201.3.209 LS EQUIPMENT OUTPUT either radiant power or radiant energy emitted by the LS EQUIPMENT 201.3.210 OCULAR HAZARD DISTANCE (OHD) distance from an EMISSION APERTURE within which the projected radiant exposure or irradiance for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the eye SI Unit: m 201.3.211
OPTICAL RADIATION electromagnetic radiation with wavelengths between 100 nm and 1 mm 201.3.212 PULSE/PULSED accessible emission with the duration shorter than 0,25 s in the range 400 nm to 700 nm and shorter than 10 s at other wavelengths
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201.3.213 PULSE DURATION time increment measured between the half peak (50 %) power points at the leading and trailing edges of a PULSE
SI Unit: second (s) 201.3.214 PULSE INTERVAL time between the end of one PULSE and the onset of the following PULSE, measured at the 50 % trailing and leading edges respectively SI Unit: second (s) 201.3.215 PULSE TRAIN
series of PULSES where the total on time of the PULSES in any series of PULSES in any single exposure sequence does not exceed 0,25 s for wavelengths in the range 400 nm to 700 nm and does not exceed 10 s for all other wavelengths
201.3.216 READY ready condition: the LS EQUIPMENT is capable of emitting OPTICAL RADIATION when the control switch is activated 201.3.217 READY INDICATOR visible or audible signal that indicates when LS EQUIPMENT is in the ready condition; the purpose of the ready indicator is to make all persons present in the vicinity aware of the need to take precautions against hazardous optical radiation
201.3.218 SET VALUE intended LS EQUIPMENT output incident on the treatment area, as set by the OPERATOR
201.3.219 SHORT WAVELENGTH BOUNDARY wavelength at the 50 % point of the emission spectrum at its short wavelength edge SI Unit: nm 201.3.220 SKIN HAZARD DISTANCE distance from an EMISSION APERTURE within which the projected radiant exposure or irradiance for a given EXPOSURE TIME equals the applicable EXPOSURE LIMIT value for the skin 201.3.221 STAND-BY stand-by condition: the power supply (SUPPLY MAINS or battery) is connected and the SUPPLY MAINS switch activated; the LS EQUIPMENT is not capable of emitting the OPTICAL RADIATION even if the control switch is activated 201.3.222 USER person, who controls the delivery of the LS EQUIPMENT OUTPUT to the treatment area SIST EN 60601-2-57:2011

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201.4 General requirements Clause 4 of the general standard applies. 201.5 General requirements for testing ME EQUIPMENT Clause 5 of the general standard applies. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows: 201.6.1 General Addition: 201.6.1.101 *Classification responsibilities The MANUFACTURER shall provide the classification of LS EQUIPMENT. The LS EQUIPMENT shall be classified on the basis of the emission of the accessible OPTICAL RADIATION over the full range of capability during operation at any time after manufacture and under every reasonably foreseeable single fault condition. NOTE Classification of LS EQUIPMENT provides the basis for the range of control measures which the USER should take in order to minimize risk of excessive exposure to OPTICAL RADIATION. 201.6.1.102 *Classification rules The classification is used to indicate the potential risk of adverse health effects.
For the purpose of classification rules, the following ranking of the risk groups, in order of increasing risk at a distance of 200 mm from the EMISSION APERTURE, shall be used. Assessment shall be made by the method specified in IEC 62471: – Exempt Group – no photo-biological HAZARD;
– Risk Group 1 – low risk group; the risk is limited by normal behavioural limitations on exposure; – Risk Group 2 – moderate risk group; the risk is limited by the aversion response to very bright light sources. However, such reflex responses do not occur universally; – Risk Group 3 – high risk group; LS EQUIPMENT that may pose a risk even for momentary or brief exposure. NOTE Risk Groups are described in IEC 62471. 201.6.1.102.1 Classification of continuous operation LS EQUIPMENT a) Exempt Risk Group
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to the Exempt Risk Group if its accessible emission does not exceed the EMISSION LIMITS in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ specified in Table 201.103. b) Risk Group 1
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 1 if its accessible emission exceeds one or more EMISSION LIMITS for the Exempt Group as defined in Table 201.101 and does not exceed EMISSION LIMITS of Risk Group 1 in any of the HAZARD SIST EN 60601-2-57:2011

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spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ specified in Table 201.103. c) Risk Group 2
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 2 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 1 as defined in Table 201.101 and does not exceed EMISSION LIMITS of Risk Group 2 in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE γ specified in Table 201.103. d) Risk Group 3
CONTINUOUS OPERATION LS EQUIPMENT shall be assigned to Risk Group 3 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 2 as defined in Table 201.101. Table 201.101 – EMISSION LIMITS for risk groups of LS EQUIPMENT HAZARD
Wavelength range nm Symbol Emission limits Units Exempt Group Risk Group 1 Risk Group 2 Actinic UV 180 – 400 Es 0,001 0,003 0,03 W⋅m2 Near UV 315 – 400 EUVA 10 33 100 W⋅m2 Blue light 300 – 700 LB 100 10 000 4 000 000 W⋅m2⋅sr1 Retinal thermal 380 – 1 400 LR 28 000/α N/Aa 71 000/α W⋅m2⋅sr1 Retinal thermal, weak visual stimulus
780 – 1 400 LIR 6 000/α N/Aa N/Aa W⋅m2⋅sr1 Corneal/lens IR
780 – 3 000 EIR 100 570 3 200 W⋅m2 NOTE 1 The list of the HAZARDS in Table 201.101 refers to eye damage and skin damage in the UV. Skin damage can also occur in the visible and IR, e.g. erythema or burning. NOTE 2 Retinal damage in the wavelength range 780 nm to 1400 nm may be affected by absence of aversion response due to weak visual stimulus a
The retinal thermal HAZARDS LR, LIR do not change with time for EXPOSURE TIMES longer than 10 s. A consequence of this is that if the EMISSION LIMIT of Exempt Risk Group is exceeded for EXPOSURE TIME up to 10 s, the LS EQUIPMENT classified on the basis of the LIR HAZARD, should be allocated to Risk Group 3. Similarly, LS EQUIPMENT classified on the basis of the retinal thermal HAZARD (LR) should be allocated to Risk Group 2 or 3, as appropriate, if the EMISSION LIMIT of the Exempt Risk Group is exceeded for EXPOSURE TIME up to 10 s.
201.6.1.102.2 Classification of PULSED LS EQUIPMENT For PULSED LS EQUIPMENT, classification criteria shall apply to the most restrictive of the requirements for a single PULSE, or any group of PULSEs within the time criteria of the applicable HAZARD region given in Table 201.102. EMISSION LIMITS for PULSED LS EQUIPMENT shall be calculated according to IEC 62471.
a) Exempt Risk Group PULSED LS EQUIPMENT shall be assigned to the Exempt Risk Group if its accessible emission does not exceed EMISSION LIMITS in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and ANGLE OF ACCEPTANCE γ specified in Table 201.103. b) Risk Group 1 PULSED LS EQUIPMENT shall be assigned to Risk Group 1 if its accessible emission exceeds one or more EMISSION LIMITS for the Exempt Group as defined in Table 201.101 and does not exceed the EMISSION LIMITS of Risk Group 1 in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 202.102 and ANGLE OF ACCEPTANCE specified in Table 201.103. SIST EN 60601-2-57:2011

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c) Risk Group 2 PULSED LS EQUIPMENT shall be assigned to Risk Group 2 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 1 as defined in Table 201.101 and does not exceed the EMISSION LIMITS of Risk Group 2 in any of the HAZARD spectral regions of Table 201.101 when assessed for the time criteria of Table 201.102 and the ANGLE OF ACCEPTANCE specified in Table 201.103. d) Risk Group 3 PULSED LS EQUIPMENT shall be assigned to Risk Group 3 if its accessible emission exceeds one or more EMISSION LIMITS for Risk Group 2 as defined in Table 201.101. Table 201.102 – Risk group time base criteria for classification of LS EQUIPMENT HAZARD
Wavelength range nm Time s Exempt Group Risk Group 1 Risk Group 2 Actinic UV 180 – 400 30 000 10 000 1 000 Near UV 315 – 400 1 000 300 100 Blue-light 300 – 700 10 000 100 0,25 Retinal thermal 380 – 1 400 10 N/A 0,25 Retinal thermal, weak visual stimulus 780 – 1 400 10 N/A N/A Corneal/lens IR 780 –3 000 1 000 100 10
Table 201.103 – Applicable ANGLE OF ACCEPTANCE for the assessment of accessible emission from LS EQUIPMENT HAZARD Wavelength range nm Angle of acceptance γ rad Exempt Risk Group Risk Group 1 Risk Group 2 Actinic UV 180 – 400 1,4 1,4 1,4 Near UV 315 – 400 1,4 1,4 1,4 Blue-light 300 – 700 0,11 0,011 0,0017 Retinal Thermal 380 – 1 400 0,011 N/A 0,0017 Retinal Thermal, weak visual stimulus 780 – 1 400 0,011 N/A N/A Corneal/Lens IR 780 – 3 000 1,4 1,4 1,4
201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201.7.9 ACCOMPANYING DOCUMENTS 201.7.9.1 General Addition: SIST EN 60601-2-57:2011

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MANUFACTURERS of LS EQUIPMENT shall provide instructions for proper operation, including clear warnings concerning precautions to avoid possible exposure to hazardous OPTICAL RADIATION. 201.7.9.2 Instructions for use 201.7.9.2.13 Maintenance Addition: MANUFACTURERS of LS EQUIPMENT shall provide instructions for maintenance to be performed by the USER, including warnings concerning precautions to avoid possible exposure to hazardous OPTICAL RADIATION. Additional subclauses: 201.7.9.2.101 Specific information for LS EQUIPMENT 201.7.9.2.101.1 Information on output The MANUFACTURER of LS EQUIPMENT shall provide the following information for the USER: – spectral irradiance or spectral radiant exposure for all intended configurations of LS EQUIPMENT; – maximum output of OPTICAL RADIATION for all intended configurations of LS EQUIPMENT, measured at the treatment area. If the LS EQUIPMENT is designed for providing treatment in different treatment areas, these parameters shall be specified for each of the treatment areas;
– maximum variation of the output from the mean value across the treatment area for all intended configurations of the equipment; – OCULAR HAZARD DISTANCE and/or SKIN HAZARD DISTANCE, when the LS EQUIPMENT is classified in excess of Risk Group 1.
For PULSED LS EQUIPMENT, for all intended operational settings of the equipment, the MANUFACTURER shall provide an additional statement of: – PULSE DURATION of individual pulses; – duration of a PULSE TRAIN; – pulse interval; – repetition rate; – number of PULSES in a PULSE TRAIN.
201.7.9.2.101.2 Safety information
MANUFACTURERS of LS EQUIPMENT shall provide the following safety information in the USER instruction: – instructions for installation, maintenance, check procedures and safe use, including clear warnings concerning precautions to avoid possible exposure to hazardous radiation or risk of fire; – recommendations for training; – legible reproductions (colour optional) of all required labels and HAZARD warnings affixed to the LS EQUIPMENT; – a clear indication of all locations of EMISSION APERTURES; SIST EN 60601-2-57:2011

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– a list of controls, adjustments and procedures for operation and maintenance by the USER, including the warning "Caution – Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure"; – a note, saying that LS EQUIPMENT should be protected against unauthorised use, for example by removal of the key from the key switch; – a recommendation for eye and skin protection for the USER and for the PATIENT/client. NOTE The MANUFACTURER should provide a warning of risk of fire if the LS EQUIPMENT is used in the presence of flammable materials, solutions or gases, or in an oxygen enriched environment. Some materials, e.g. darkly coloured clothing or cotton wool, when saturated with oxygen, may be ignited by the high temperatures produced in NORMAL USE of the LS EQUIPMENT.
Additional paragraphs: 201.7.101 Labelling of LS EQUIPMENT 201.7.101.1 Labelling requirements The MANUFACTURER of LS EQUIPMENT shall provide product risk group marking. The label shall include the risk group number and wording according to Table 201.104. NOTE Wording that conveys an equivalent meaning is acceptable. Table 201.104 – Requirements for labelling of LS EQUIPMENT according to risk group classification Hazard Exempt Group Risk Group 1 Risk Group 2 Risk Group 3 Actinic UV Not required CAUTION UV emitted from this device CAUTION UV emitted from this device Eye or skin irritation may result WARNING UV emitted from this device may be hazardous Avoid eye or skin exposure Near UV Not required CAUTION UV emitted from this device CAUTION UV emitted from this device Eye irritation may result WARNING UV emitted from this device may be hazardous Avoid eye exposure Blue-light Not required Not required CAUTION The light emitted may be harmful to the eyes Do not stare at the light source WARNING The light emitted may result in eye injury Do not look at the light source Retinal Thermal Not required Not applicable CAUTION The light emitted may be harmful to the eyes Do not stare at the light source Retinal Thermal, weak visual stimulus Not required Not applicable Not applicable WARNING IR emitted from this device may cause eye injury Avoid eye exposure Corneal/ Lens IR Not required CAUTION IR emitted from this device Do not stare at the IR source CAUTION IR emitted from this device may cause eye irritation Do not stare at the light source
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When LS EQUIPMENT emits OPTICAL RADIATION in more than one HAZARD spectral region, it shall be classified for the most restrictive case. If the OPTICAL RADIATION in other spectral regions exceeds the EMISSION LIMITS for the Exempt Group, appropriate warning shall be included in the product explanatory label.
NOTE For example, for the device classified as a Risk Group 3 product on the basis of a retinal IR HAZARD and emitting UV to the level of Risk Group 2, the legend of the label should indicate Risk Group 3, with the appropriate ‘Wa
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