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Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Adopted IEC 60601-2-37:2007, second edition, 2007-08) | Appareils électromédicaux -
분야 | 11 : LG Electronics |
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적용범위 | Preface This is the second edition of CAN/CSA-C22.2 No. 60601-2-37, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-37 (second edition, 2007-08). It supersedes the previous edition published in 2003 as CAN/CSA-C22.2 No. 60601-2-37, Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (adopted IEC 60601-2-37:2001). 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 CEI/IEC 60601-1:2005, with Canadian deviations). Scope Addition: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter 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 this standard. NOTE See also subclause 4.2 of this standard. This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. --------------------------------------------------------------------------------------------------------- Pr?face? Ce document constitue la deuxi?me ?dition de la CAN/CSA-C22.2 nº 60601-2-37, Appareils ?lectrom?dicaux - Partie 2-37 : Exigences particuli?res pour la s?curit? de base et les performances essentielles des appareils de diagnostic et de surveillance m?dicaux ? ultrasons. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission ?lectrotechnique Internationale) 60601-2-37 (deuxi?me ?dition, 2007-08), qui porte le m?me titre. Cette norme remplace l'?dition pr?c?dente publi?e en 2003 et intitul?e CAN/CSA-C22.2 nº 60601-2-37, Appareils ?lectrom?dicaux - Partie 2-37 : R?gles particuli?res de s?curit? pour les appareils de diagnostic et de surveillance m?dicaux ? ultrasons (norme CEI 60601-2-37:2001 adopt?e). Cette norme fait partie d'une s?rie de normes publi?es par CSA lesquelles constituent le Code canadien de l'?lectricit?, Deuxi?me partie. Cette norme est con?ue pour ?tre utilis?e de concert avec la norme CAN/CSA-C22.2 nº 60601-1:08, Appareils ?lectrom?dicaux - Partie 1 : Exigences g?n?rales pour la s?curit? de base et les performances essentielles (norme CEI/IEC 60601-1:2005 adopt?e, avec exigences propres au Canada). Domaine d’application Addition: La pr?sente Norme Internationale s'applique ? la S?CURIT? DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE DIAGNOSTIC ? ULTRASONS comme d?finis en 201.3.217, d?sign?s ci-apr?s sous le terme APPAREILS EM. Si un article ou un paragraphe est sp?cifiquement destin? ? ?tre applicable uniquement aux APPAREILS EM ou uniquement aux SYST?MES EM, le titre et le contenu de cet article ou de ce paragraphe l'indique. Si cela n'est pas le cas, l'article ou le paragraphe s'applique ? la fois aux APPAREILS EM et aux SYST?MES EM, selon le cas. Les DANGERS inh?rents ? la fonction physiologique pr?vue de L'APPAREIL EM ou du SYST?ME 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 de 8.4.1 de la pr?sente norme. NOTE Voir ?galement le paragraphe 4.2 de la pr?sente norme. La pr?sente norme particuli?re ne couvre pas les appareils th?rapeutiques ? ultrasons. Les appareils utilis?s pour r?aliser l'imagerie ou le diagnostic de structures du corps par ultrasons, en association avec une autre proc?dure m?dicale, sont couverts. |
국제분류(ICS)코드 | |
페이지수 | 105 |
Edition |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | CSA C22.2 NO. 60601-2-37:08 + A1:19 (R2023) (CONSOLIDATED) | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Adopted IEC 60601-2-37:2007, second edition, 2007-08, consolidated with amendment 1 | 2019-01-01 | 표준 |
2 | CSA C22.2 NO. 60601-2-37:08 (R2023) | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Adopted IEC 60601-2-37:2007, second edition, 2007-08) | Appareils électromédicaux - | 2008-01-01 | 표준 |
CAN/CSA-C22.2 NO. 60601-2-38-03 (R2007) - Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds (Adopted CEI/IEC 601-2-38:1996, first edition, 1996-10, including Amendment 1:1999) | Appareils électromédicaux - Partie 2: Règles particu 상세보기
CAN/CSA-C22.2 NO. 60601-1-8:08 (R2023) - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adop 상세보기
CSA C22.2 NO. 60601-1-3:09 (R2019) - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment (Adopted IEC 60601-1:2008, second edition, 2008-01) | Appareils électromédic 상세보기
CSA C22.2 NO. 60601-1-10:09 (R2020) - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Adopted IEC 60601-1-10:2007, first edition, 2007-11) 상세보기
CSA C22.2 NO. 60601-2-44:10 (R2019) - Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009, third edition, 2009-02) | Appareils électromédicaux - Partie 2-44: Ex 상세보기
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