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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 (Adopted IEC 80601-2-58:2014, second edition, 2014-09, with Canadian dev
분야 | 11 : LG Electronics |
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적용범위 | Preface This is the second edition of CAN/CSA-C22.2 No. 80601-2-58, 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, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-58 (second edition, 2014-09). It supersedes the previous edition published in 2010 as CAN/CSA-C22.2 No. 80601-2-58 (adopted IEC 80601-2-58:2008). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as "CAN/CSA-C22.2 No. 80601-2-58" throughout. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations). Scope? 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 LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 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 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. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be connected to the ME EQUIPMENT and are to be tested together or individually. -------------------------------------------------------------------------------------------------------------------------------- Pr?face? Ce document constitue la deuxi?me ?dition de la CAN/CSA-C22.2 nº 80601-2-58, Appareils ?lectrom?dicaux ? Partie 2-58 : Exigences particuli?res pour la s?curit? de base et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme IEC (Commission ?lectrotechnique Internationale) 80601-2-58 (deuxi?me ?dition, 2014-09) qui porte le m?me titre. Cette norme remplace l’?dition ant?rieure, publi?e en 2010 qui portait la d?signation CAN/CSA-C22.2 nº 80601-2-58 (norme IEC 80601-2-58:2008 adopt?e). Elle fait partie d’une s?rie de normes publi?es par le Groupe CSA qui constituent le Code canadien de l’?lectricit?, Deuxi?me partie. Par souci de bri?vet?, tout au long de ce document, il sera appel? ?CAN/CSA-C22.2 nº 80601-2-58?. Cette norme est con?ue pour ?tre utilis?e de concert avec la CAN/CSA-C22.2 nº 60601-1:14, Appareils ?lectrom?dicaux ? Partie 1 : Exigences g?n?rales pour la s?curit? de base et les performances essentielles (norme IEC 60601-1:2005+A1:2012 adopt?e, avec exigences propres au Canada). Domaine d’application? L’Article 1 de la norme g?n?rale s’applique avec les exceptions suivantes: 201.1.1 * Domaine d’application Remplacement: La pr?sente Norme internationale s’applique ? la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des DISPOSITIFS DE RETRAIT DU CRISTALLIN et des DISPOSITIFS DE VITRECTOMIE pour la chirurgie ophtalmique (tel que d?fini en 201.3.208 et 201.3.217) et des ACCESSOIRES li?s qui peuvent ?tre raccord?s ? ces APPAREILS ELECTROMEDICAUX, d?sign?s ci-apr?s comme APPAREILS EM. Si un article ou un paragraphe est sp?cifiquement destin? ? ?tre 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 ? la fois aux APPAREILS EM et aux SYSTEME EM, selon le cas. Les DANGERS inh?rents ? la fonction physiologique pr?vue de L’APPAREIL EM ou des SYSTEMES EM dans le cadre du domaine d’application de la pr?sente norme ne sont pas couverts par des exigences sp?cifiques contenues dans la pr?sente norme, ? l’exception de 7.2.13 et 8.4.1 de la norme g?n?rale. NOTE Voir aussi 4.2 de la norme g?n?rale. 201.1.2 Objet Remplacement: L’objet de la pr?sente norme particuli?re est d’?tablir les exigences particuli?res de SECURITE DE BASE et de PERFORMANCES ESSENTIELLES pour les DISPOSITIFS DE RETRAIT DU CRISTALLIN et les DISPOSITIFS DE VITRECTOMIE pour la chirurgie ophtalmique (comme d?finis en 201.3.208 et 201.3.217.) et les ACCESSOIRES associ?s qui peuvent ?tre raccord?s aux APPAREILS EM et doivent ?tre soumis aux essais ensemble ou individuellement. |
국제분류(ICS)코드 | |
페이지수 | 84 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | C22.2 NO. 80601-2-58:15 (R2020) | 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 (Adopted IEC 80601-2-58:2014, second edition, 2014-09, with Canadian dev | 2015-01-01 | 표준 |
CSA C22.2 NO. 80601-2-71:17 (R2022) - Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (Adopted IEC 80601-2-71:2015, first edition, 2015-06, with Canadian deviations) 상세보기
CSA C22.2 NO. 80601-2-72:17 (R2022) - Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadia 상세보기
CSA C22.2 NO. 80601-2-58A:15 (R2020) - Amendment 1:2018 to CSA C22.2 NO. 80601-2-58:15, 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 (Adopted amendment 1:20 상세보기
CSA C22.2 NO. 80601-2-30:19 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Adopted IEC 80601-2-30:2018, second edition, 2018-03) | Appareils électromédicaux - Partie 2-30: 상세보기
CSA C22.2 NO. 80601-2-77:19 - Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Adopted IEC 80601-2-77:2019, first edition, 2019-07, with Canadian deviations) | Appareils électro 상세보기
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