EN 60601-2-22:2013

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, therapeutische und diagnostische LasergeräteAppareils électromédicaux - Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laserMedical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment31.260Optoelektronika, laserska opremaOptoelectronics. Laser equipment11.040.60Terapevtska opremaTherapy equipment11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-22:2013SIST EN 60601-2-22:2013en01-marec-2013SIST EN 60601-2-22:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD EN 60601-2-22 NORME EUROPÉENNE
EUROPÄISCHE NORM January 2013
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2013 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-22:2013 E
ICS 11.040.01; 31.260 Supersedes EN 60601-2-22:1996
English version
Medical electrical equipment -
Part 2-22: Particular requirements for basic safety
and essential performance of surgical, cosmetic, therapeutic
and diagnostic laser equipment (IEC 60601-2-22:2007 + A1:2012)
Appareils électromédicaux -
Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques
et de diagnostic à laser (CEI 60601-2-22:2007 + A1:2012)
Medizinische elektrische Geräte -
Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, kosmetische, therapeutische
und diagnostische Lasergeräte (IEC 60601-2-22:2007 + A1:2012)
This European Standard was approved by CENELEC on 2012-11-29. 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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management Centre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Foreword The texts of document 76/359/FDIS, future edition 3 of IEC 60601-2-22, and document 76/444/CDV, future amendment 1 to edition 3 of IEC 60601-2-22, prepared by IEC/TC 76 "Optical radiation safety and laser equipment" were submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-22:2013, based on IEC 60601-2-22:2007 + A1:2012.
The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-08-29 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2015-11-29
This document supersedes EN 60601-2-22:1996.
This standard is to be read in conjunction with EN 60601-1:2006.
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. SIST EN 60601-2-22:2013

- 3 - EN 60601-2-22:2013
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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standards IEC 60601-2-22:2007 + A1:2012 were approved by CENELEC as a European Standard without any modification. The Bibliography of EN 60601-1:2006 applies, except as follows:
In the Bibliography of EN 60601-1:2006, the following note has to be added for the standard indicated:
IEC 60664-3:2003 NOTE Harmonised as EN 60664-3:2003 (not modified).
Annex ZA
(normative)
Normative references to international publications with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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:
Publication Year Title EN/HD Year Add to Annex ZA of EN 60601-1:2006 the following new references: IEC 60825-1 2007 Safety of laser products -
Part 1: Equipment classification
and requirements EN 60825-1 2007
IEC 60947-3 - Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors,
switch-disconnectors and fuse-combination units EN 60947-3 -
IEC 61010-1 - Safety requirements for electrical
equipment for measurement, control
and laboratory use -
Part 1: General requirements EN 61010-1 -
- 5 - EN 60601-2-22:2013
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, except the following:
- ER 1 to ER 7.1 - ER 7.4 - ER 7.5, Paragraph 2 and 3 - ER 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive[s] concerned.
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
IEC 60601-2-22 Edition 3.1 2012-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Appareils électromédicaux – Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laser
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01, 31.260 ISBN 978-2-8322-0443-6
– 2 – 60601-2-22  IEC:2007+A1:2012 CONTENTS FOREWORD . 3 INTRODUCTION . 6
201.1 Scope, object and related standards. 7 201.2 Normative references . 9 201.3 Terms and definitions . 9 201.4 General requirements . 11 201.5 General requirements for testing ME EQUIPMENT . 11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11 201.7 ME EQUIPMENT identification, marking and documents . 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14 201.10 Protection against unwanted and excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16 201.13 HAZARDOUS SITUATIONS and fault conditions . 17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18 201.15 Construction of ME EQUIPMENT . 18 201.16 ME SYSTEMS. 19 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
Annexes . 19 Annex D (informative)
Symbols on marking . 19 Annex AA (informative)
Particular guidance and rationale . 22
Bibliography . 24 Index of defined terms used in this particular standard. 25
Table D.1 – General symbols . 19
60601-2-22  IEC:2007+A1:2012 – 3 – INTERNATIONAL ELECTROTECHNICAL COMMISSION ________________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic
and diagnostic laser equipment
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.
This consolidated version of IEC 60601-2-22 consists of the third edition (2007) [documents 76/359/FDIS and 76/363/RVD] and its amendment 1 (2012) [documents 76/444/CDV and 76/477/RVC]. It bears the edition number 3.1. The technical content is therefore identical to the base edition and its amendment and has been prepared for user convenience. A vertical line in the margin shows where the base publication has been modified by amendment 1. Additions and deletions are displayed in red, with deletions being struck through.
– 4 – 60601-2-22  IEC:2007+A1:2012 International standard IEC 60601-2-22 has been prepared by IEC subcommittee 76: Optical radiation safety and laser equipment. This third edition takes account of the recently published new editions of the General Standard IEC 60601-1 and Group safety publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 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 The committee has decided that the contents of the base publication and its amendments 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.
60601-2-22  IEC:2007+A1:2012 – 5 – NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of the amendment 1 be adopted for implementation nationally not earlier than 12 months from the date of publication.
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 publication using a colour printer.
– 6 – 60601-2-22  IEC:2007+A1:2012 INTRODUCTION This particular standard amends and supplements IEC 60601-1 (third edition, 2005: Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance). This standard also refers to IEC 60825-1 (2007). The requirements of this standard are the minimum that need to be complied with, in order to achieve a reasonable level of safety and reliability during operation and application of medical laser equipment. 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. Understanding of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revisions necessitated by changes in clinical practice or by developments in technology.
60601-2-22  IEC:2007+A1:2012 – 7 – MEDICAL ELECTRICAL EQUIPMENT –
Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic
and diagnostic laser equipment
201.1 Scope, object and related standards Clause 1 of the General Standard applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. Throughout this International Standard, light emitting diodes (LED) are included whenever the word “laser” is used. NOTE 1 Refer to Definition 3.49 in IEC 60825-1. NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the General Standard. NOTE See also 4.2 of the General Standard. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the safety of surgical, cosmetic, therapeutic and diagnostic laser equipment. NOTE Laser classification (IEC 60825-1) must not be confused with electrical classification (IEC 60601-1). SIST EN 60601-2-22:2013

– 8 – 60601-2-22  IEC:2007+A1:2012 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 Clause 2 of this particular standard. IEC 60601-1-3 does not apply. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in this standard 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 sections, clauses and subclauses of this particular standard corresponds to that of the General Standard or applicable collateral standard. 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 or figures which are additional to those of the General Standard are numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures 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. Where there is no corresponding section, clause or subclause in this particular standard, the section, 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. Concerning LASER RADIATION safety of laser equipment, IEC 60825-1 applies, except that the relevant requirements are specified, changed or amended in this particular standard. Clauses and subclauses of the General Standard and IEC 60825-1, which are not applicable to laser equipment for medical applications, are not necessarily indicated as "not applicable". SIST EN 60601-2-22:2013

60601-2-22  IEC:2007+A1:2012 – 9 – 201.2 Normative references Clause 2 of the General Standard applies, except as follows: Addition: IEC 60825-1:2007, Safety of laser products – Part 1: Equipment classification and requirements
IEC 60947-3, Low-voltage switchgear and controlgear – Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1: General requirements 201.3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and IEC 60825-1:2007 apply, except as follows: Addition: 201.3.101
ACCESSIBLE EMISSION LIMIT (AEL) ACCESSIBLE EMISSION LIMIT for CLASS 1M, 2, 2M, 3R, or 3B lasers (see 3.3 and Tables 4 through 9 of IEC 60825-1) 201.3.102
AIMING BEAM beam of optical radiation, producing a visible AIMING BEAM SPOT, intended for indication of the anticipated point of impact of the WORKING BEAM 201.3.103
AIMING BEAM SPOT area of impact of the AIMING BEAM within the WORKING AREA 201.3.104 AIMING LASER LASER emitting an AIMING BEAM 201.3.105 APERTURE distal opening of the BEAM DELIVERY SYSTEM (see 3.8 of IEC 60825-1) 201.3.106 BEAM DELIVERY SYSTEM optical system which guides the LASER RADIATION from its origin to the WORKING AREA 201.3.107 CLASS 1, 1M, 2, 2M, 3R, 3B, OR 4 LASER PRODUCT laser equipment, incorporating a LASER as defined in 3.41 and 3.18 through 3.23 of IEC 60825-1 201.3.108 EMERGENCY LASER STOP hand- or foot-actuated device intended to stop the LASER OUTPUT immediately in case of emergency SIST EN 60601-2-22:2013

– 10 – 60601-2-22  IEC:2007+A1:2012 201.3.109 LASER EMISSION CONTROL SWITCH hand- or foot-actuated device intended to initiate and stop WORKING BEAM emission through any APERTURE 201.3.110 LASER EMISSION INDICATOR visible and/or audible signal which indicates that the WORKING BEAM is being emitted through any APERTURE NOTE The LASER EMISSION INDICATOR is different from the LASER RADIATION EMISSION warning requirement 4.7 of IEC 60825-1. 201.3.111 LASER ENERGY RADIANT ENERGY of the WORKING BEAM, incident on the WORKING AREA (see 3.70 of IEC 60825-1) 201.3.112 LASER OPERATOR the person who handles the laser equipment. In general, the LASER OPERATOR controls the delivery of the laser radiation to the WORKING AREA. The LASER OPERATOR may appoint other person(s), who assist with the selection and/or setting of the parameters Refer to Definition 3.73 in IEC 60601-1. NOTE The safety requirements in this standard apply to all above persons.
201.3.113 LASER OUTPUT either LASER POWER or LASER ENERGY 201.3.114 LASER POWER RADIANT POWER of the WORKING BEAM, incident on the WORKING AREA, see 3.72 of IEC 60825-1 201.3.115 LASER READY INDICATOR visible means which indicate that the laser equipment is in the READY condition, and the purpose of which is to make all persons present in the laser area aware of the need to take precautions against hazardous LASER RADIATION, as detailed in the ACCOMPANYING DOCUMENTS (instructions for use). See 201.7.9. 201.3.116 OPERATOR PROTECTIVE FILTER a moveable or fixed filter which does not allow radiation in excess of the MAXIMUM PERMISSIBLE EXPOSURE (MPE) to the LASER OPERATOR NOTE For the definition of MPE, see 3.56 of IEC 60825-1. 201.3.117 SHUTTER electronic, opto-electronic and/or mechanical means which allows or prevents LASER OUTPUT to be emitted from the APERTURE 201.3.118 STAND-BY/READY modes of operation when mains supply is connected and the mains switch activated, where the STAND-BY mode means that the laser is not capable of emitting the WORKING BEAM even if the laser control switch is activated, and where the READY mode keeps the laser equipment enabled, so that it is capable of emitting LASER OUTPUT when the control switch is activated SIST EN 60601-2-22:2013

60601-2-22  IEC:2007+A1:2012 – 11 – 201.3.119 TARGET INDICATING DEVICE an aiming device which designates the position where the WORKING BEAM will perform its surgical, cosmetic, therapeutic or diagnostic purpose 201.3.120 WORKING AREA area which is intended to be irradiated with WORKING BEAM 201.3.121 WORKING BEAM beam of LASER RADIATION emitted by the laser equipment for surgical, cosmetic, therapeutic or diagnostic purposes (other than the AIMING BEAM) 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. 201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the General Standard applies, except as follows: 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts Addition: 201.7.2.101 Additional items
See Clause 5 of IEC 60825-1. a) General
Laser equipment shall carry labels in accordance with 5.5, 5.6, 5.8, 5.9, 5.10, 5.11 of IEC 60825-1, as applicable. b)* Aperture label
Laser equipment shall have a label positioned as close as practicable to each laser aperture. The label shall be similar to the laser hazard symbol as specified in IEC 60825-1, Figure 1, with the exception that the size can be adjusted as appropriate or alternatively be similar to the label described in 5.7 of IEC 60825-1. Hand-pieces and other applicators are exempt from these requirements. In this case, a label is to be affixed in a prominent position with either:
– a statement that the laser aperture is on the end of the fibre/applicator, or
– a symbol as detailed in Table D.1, number 113. NOTE The required information can be combined into one single label if the area where the label is to be affixed is suitable. SIST EN 60601-2-22:2013

– 12 – 60601-2-22  IEC:2007+A1:2012 201.7.9 ACCOMPANYING DOCUMENTS 201.7.9.1 General Addition: The ACCOMPANYING DOCUMENTS shall give adequate instructions for proper operation, including clear warnings concerning precautions to avoid possible exposure to hazardous LASER RADIATION. 201.7.9.2 Instructions for use 201.7.9.2.13 Maintenance Addition: The instructions for main
...