IEC 60601-2-22-ed.4.0

Annotation of standard text IEC 60601-2-22-ed.4.0 :

IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4. Medical Electrical Equipment or Medical Electrical Systems which incorporate lasers as sources of energy being transferred to the Patient or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. Laser Products for these applications classified as a Class 1, Class 1M, Class 2, Class 2M or Class 3R Laser Product, are covered by IEC 60825-1:2014 and by the general standard. 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 to ME Equipment and to ME Systems, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. If the laser equipment is Class 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition; b) it addresses technical and safety issues which have arisen since publication of the third edition; c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4; d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57. LIEC 60601-2-22:2019 sapplique a la Securite de Base et aux Performances Essentielles des appareils a laser pour applications chirurgicales, therapeutiques, de diagnostic medical, esthetiques ou veterinaires destines a etre utilises sur les personnes ou les animaux; ils sont classes comme Appareils a Laser de Classe 1C, le Laser Enferme etant de Classe 3B ou 4, ou de Classe 3B, ou de Classe 4. Les Appareils Electromedicaux ou les Systemes Electromedicaux integrant des lasers comme sources d’energie transferees au Patient ou a l’animal, les lasers etant conformes aux specifications ci-dessus, sont designes par le terme “appareils a laser” dans le present document. Les Appareils a Laser pour ces applications, classes Appareils a Laser de Classe 1, Classe 1M, Classe 2, Classe 2M ou Classe 3R, sont couverts par l’IEC 60825-1:2014 et par la norme generale. Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux Appareils EM ou uniquement aux Systemes EM, le titre et le contenu de cet article ou de ce paragraphe lindiquent. Si cela nest pas le cas, larticle ou le paragraphe sapplique aux Appareils EM et aux Systemes EM, selon le cas. Les Dangers inherents a la fonction physiologique prevue des appareils a laser dans le cadre du domaine dapplication du present document ne sont pas couverts par des exigences specifiques contenues dans le present document a lexception de 7.2.13, Effets physiologiques, de la norme generale. Si les appareils a laser sont de la Classe 1C selon l’IEC 60825-1:2014 et sont utilises en tant qu’appareil a laser pour un usage domestique, ils sont couverts par l’IEC 60335-2-113:2016. Cette quatrieme edition annule et remplace la troisieme edition parue en 2007 et lAmendement 1:2012. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) elle prend en compte lIEC 60601-1:2005/AMD1:2012 et lIEC 60825-1:2014, qui ont ete publies depuis la publication de la troisieme edition; b) elle traite des questions techniques et de securite soulevees depuis la publication de la troisieme edition; c) le domaine d’application de cette quatrieme edition differe de celui de la troisieme edition. Il inclut desormais les appareils a laser de Classe 1C, tels que definis dans l’IEC 60825-1:2014, alors que le laser enferme est un laser de Classe 3B ou 4; d) les appareils a LED (diode electroluminescente) sont a present exclus du present document etant donne que les appareils medicaux a LED peuvent etre couverts par l’IEC 60601-2-57.