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      • CSA C22.2 NO. 60601-2-57:11 (R2021)

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      CSA C22.2 NO. 60601-2-57:11 (R2021)

      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 (Adopted IEC 60601-2-57:2011, first edition, 2011-01) | 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 (norme IEC 60601-2-57:2011 adoptée, première édition, 2011-01)
      SKU: 2703383 Published by CSA Group Publication Year 2011 Reaffirmed in 2021

      Product Details

      • Preface/Scope
      • Items Included

      CSA Preface


      This is the first edition of CAN/CSA-C22.2 No. 60601-2-57, 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, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-57 (first edition, 2011-01). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.


      This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, with Canadian deviations).


      This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.


      This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


      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 photobiological 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.


      --------------------------------------------------------------------------------------------------------------------------------


      Préface CSA


      Ce document constitue la première édition de la CAN/CSA-C22.2 nº 60601-2-57, 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. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission Électrotechnique Internationale) 60601-2-57 (première édition, 2011-01), qui porte le même titre. Cette norme fait partie d'une série de normes publiées par CSA lesquelles constituent le Code canadien de l'électricité, Deuxième partie.


      Cette norme est conçue pour être utilisée de concert avec la norme CAN/CSA-C22.2 nº60601-1:08, Appareils électromédicaux - Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles (norme CEI 60601-1:2005 adoptée, avec exigences propres au Canada).


      Cette norme est jugée convenable à l'évaluation de la conformité selon le domaine d'application établi dans la norme.


      Cette norme a été élaborée conformément aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a été publiée en tant que Norme nationale du Canada par Groupe CSA.


      Domaine d'application


      Replacement:


      La présente Norme internationale 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 (APPAREILS À SL).


      La présente norme n'est pas applicable aux appareils de bronzage, aux appareils ophtalmiques ou de photothérapie pour nourrissons.


      NOTE Les exigences de sécurité de la présente norme particulière sont destinées à traiter uniquement les DANGERS pour les yeux et la peau, les DANGERS pour les tissus internes n'étant pas inclus dans son domaine d'application.


      Les APPAREILS À SL 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.


      NOTE Les Annexes AA à EE ont été incluses, afin de présenter des lignes directrices générales illustrées de plusieurs cas pratiques. Toutefois, il convient de ne pas considérer ces annexes comme définitives ou exhaustives.

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      CSA C22.2 NO. 60601-2-57:11 (R2021)

      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 (Adopted IEC 60601-2-57:2011, first edition, 2011-01) | 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 (norme IEC 60601-2-57:2011 adoptée, première édition, 2011-01)

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