IEC 60601-2-37-ed.3.0

Detail information

Designation: IEC 60601-2-37-ed.3.0

Publication date: 02/07/2024

Pages: 118

Country: International technical standard

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Anotation

IEC 60601-2-37:2024 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 document are not covered by specific requirements in this document except in 201.7.2.13. This document 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. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised. LIEC 60601-2-37:2024 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE DIAGNOSTIC A ULTRASONS comme cela est defini en 201.3.217, designes ci-apres sous le terme APPAREILS EM. Si un article ou un paragraphe est destine specifiquement 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 cela 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 de lAPPAREIL EM ou du SYSTEME EM dans le cadre du domaine dapplication du present document ne sont pas couverts par des exigences specifiques contenues dans le present document, a lexception du 201.7.2.13. Le present document ne couvre pas les appareils therapeutiques a ultrasons. Les appareils utilises pour realiser limagerie ou le diagnostic de structures du corps par ultrasons, en association avec une autre procedure medicale, sont couverts. LIEC 60601-2-37:2024 annule et remplace la deuxieme edition parue en 2007, et l’Amendement 1:2015. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) modifications techniques et redactionnelles, qui resultent de la norme generale amendee IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 et IEC 60601-1:2005/AMD2:2020 et de ses normes collaterales IEC 60601-1-xx ; b) modifications techniques et redactionnelles qui resultent de la maintenance des references normatives ; c) modifications techniques et redactionnelles qui resultent des evolutions correspondantes des normes du CE 87 Ultrasons. En particulier, l’Article 201.11 concernant la protection contre les temperatures excessives et les autres dangers a ete entierement revise.