Edlition 2.02023-07
INTERNATIONAL STANDARD
NORME INTERNATIONALE
Medicalelectricalequipment-Part 2-57:Particularrequirements for thebasic safety and essential performancemonitoring cosmeticand aestheticuse ofnon-laser lightsource equipment intended fortherapeutic diagnostic
Appareilselectromedicaux-essentielles desappareilsa source delumierenonlaserdestinesadesusagestherapeutiques de diagnostic de surveillance cosmetiqueset esthetiques
Partie2-57:Exigencesparticulierespourla securitedebaseetlesperformances
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Edition 2.02023-07
INTERNATIONAL STANDARD
NORME INTERNATIONALE
Medicalelectricalequipment-Part 2-57:Particularrequirements for the basic safety and essentialdiagnostic monitoring cosmetic and aesthetic use performance ofnon-laser light sourceequipmentintended fortherapeutic
Appareilselectromedicaux-performancesessentielles des appareilsa source delumierenon laser destines Partie2-57:Exigencesparticulierespourlasecuritedebaseetlesadesusages therapeutiques dediagnostic de surveillance cosmetiquesetesthetiques
ELECTROTECHNICAL INTERNATIONALCOMMISSION
COMMISSIONELECTROTECHNIQUEINTERNATIONALE
ICS 11.040.50 11.040.60
ISBN 978-2-8322-7296-1
CONTENTS
FOREWORD. .3INTRODUCTION. 6201.1 201.2 Scope object and related standards Normative references. ..9 .7201.3 Terms and definitions. .9201.4 General requirements ...12201.5 General requirements for testing ME EQuIPMENT .13201.6 Clas sification of ME EQUIPMENT and ME SYSTEMS. ..13.201.7 201.8 ME EQuiPMENT identification marking and documents Protection against electrical HAZARDs from ME EQuIPMENT .17 13201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .... ...18201.10 Protection against unwanted and excessive radiation HAzARDS 18201.11 21201.12 Accuracy of controls and instruments and protection against HAzARDous outputs .. .21201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 22201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 22201.15 Construction of ME EQUIPMENT. 22201.16 201.17 ME SYSTEMS. Electromagnetic patibility of ME EQuIPMENT and ME SYSTEMS 22 22AnnexesAnnex AA (informative) Particular guidance and rationale 24Annex BB (informative)Summary of MANuFACTuRER’s requirements .26Annex CC (informative) Symbols on marking Bibliography.. 27Index of defined terms used in this document . .28 .29
Figure 201.101 - Example of explanatory label for a device with multiple hazardspectral regions .... Figure 201.102 - Example of explanatory label.. .14 14Figure 201.103-Reproduction of the OPTICAL RADIATiON warning symbol(ISO 7010:W027:2011-05) ... .15
Table 201.104 - Requirements for marking of LS EQuiPMENT according to risk groupclassification.... .14Table BB.1 - Summary of MANuFACTuRER's requirements 26Table CC.1 - Symbols references and descriptions ..27
INTERNATIONAL ELECTROTECHNICALCOMMISSION
MEDICALELECTRICALEQUIPMENT-
Part2-57:Particularrequirementsforthebasicsafetyandessential diagnostic monitoring cosmeticandaestheticuse
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization prising
all national electrotechnical mittees (IEC National Committees). The object of IEC is to promote international co-operation on allquestions concerning standardization in the electrical and electronic fields. To this end andPublicly Available Specifications (PAS)and Guides (hereafter referred to as *IEC Publication(s)²). Their in addition to other activities IEC publishes International Standards Technical Specifications Technical Reports preparation is entrusted to technical mittees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International governmental and non-governmental organizations liaisingStandardization (ISO) in accordance with conditions determined by agreement between the two organizations.2)Theformal decisions oragreements of IEC on technical matters expressasnearly as possibleaninternationalinterested IEC National Committees.4) In order to promote international uniformity IEC National Committees undertake to apply IEC Publications misinterpretation by any end user.any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.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.7)No liabity shallattach t IECorits directorsemlyeesservantsoragents inclding individual experts andmembers of its technical mittees and IEC National Committees for any personal injury property damage orexpenses 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 isindispensable for the correct application of this publication.in respect thereof. As of the date of publication of this document IEC had not received notice of (a) patent(s). (a) patent(s). IEC takes no position concerning the evidence validity or applicability of any claimed patent rights IC shall not be held responsible for identifying any or all such patent rights. which may be required to implement this document. However implementers are cautioned that this may not
IEC 60601-2-57 has been prepared by IEC technical mittee 76: Optical radiation safety andlaser equipment. It is an International Standard.
This second edition cancels and replaces the first edition published in 2011. This editionconstitutes a technical revision.
edition:
a)This edition constitutes a major review of the previous edition and covers the recent development of LS EQUIPMENT. It now includes the RISK GROuP 1C (RG-1C). LS EQUIPMENTof RG-1C incorporates technical means which inhibit emission into free space when theAPPLICATOR is not in GOOD CONTACT with the target tissue.
