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IEC 80601-2-58-ed.3.0
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
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STANDARD published on 6.3.2024
The information about the standard:
Designation standards: IEC 80601-2-58-ed.3.0
Publication date standards: 6.3.2024
SKU: NS-1168243
The number of pages: 79
Approximate weight : 237 g (0.52 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 80601-2-58-ed.3.0 :
IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. 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 document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method. LIEC 80601-2-58:2024 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des DISPOSITIFS DE RETRAIT DU CRISTALLIN et des DISPOSITIFS DE VITRECTOMIE pour la chirurgie ophtalmique (comme cela est defini en 201.3.209 et 201.3.217) et des ACCESSOIRES lies qui peuvent etre raccordes a ces APPAREILS ELECTROMEDICAUX, designes ci-apres comme APPAREILS EM. Lorsqu’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 l’indiquent. Si ce n’est pas le cas, l’article ou le paragraphe s’applique a la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les DANGERS inherents a la fonction physiologique prevue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d’application du present document ne sont pas couverts par des exigences specifiques contenues dans le present document, a l’exception du 7.2.13 de l’IEC 60601-1:2005 et l’IEC 60601-1:2005/AMD2:2020 et du 8.4.1 de l’IEC 60601-1:2005. LIEC 80601-2-58:2024 le et remplace la deuxieme edition parue en 2014 et son Amendement 1:2016. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) alignement de la presente norme particuliere sur la base des amendements de l’IEC 60601-1:2005, lIEC 60601-1:2005/AMD1:2012 et de lIEC 60601-1:2005/AMD2:2020; b) mise a jour des references a l’IEC 60601-1:2005, lIEC 60601-1:2005/AMD1:2012 et lIEC 60601-1:2005/AMD2:2020 et aux normes particulieres et collaterales pour les aligner sur les amendements de l’IEC 60601-1:2005, lIEC 60601-1:2005/AMD1:2012 et lIEC 60601-1:2005/AMD2:2020 et des autres normes collaterales; c) mise a jour des references normatives; d) ajout d’une nouvelle exigence relative aux corps solides qui proviennent des PARTIES APPLIQUEES dans le 201.9.5.101; e) ajout de la methode de la lumiere rasante dans le 201.12.1.101.7; f) clarification des conditions d’essai pour les exigences de CEM dans le 202.7.1.2; g) mise a jour des references du Tableau D.4 pour inclure les references IEC specifiques aux symboles et supprimer le "201.7.6.101" existant de l’"Annexe AA"; h) inclusion d’une nouvelle annexe pour couvrir les exigences generales pertinentes en matiere de securite et de performances du reglement europeen (UE) 2017/745 (Annexe BB). i) suppression de toutes les references a la methode de RETRAIT DU CRISTALLIN au moyen de la FRAGMENTATION PAR LIQUEFACTION.
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