IEC 60601-2-54-ed.2.0

Podrobné informácie

Označenie: IEC 60601-2-54-ed.2.0

Dátum vydania: 26.09.2022

Stránok: 161

Krajina: Medzinárodná technická norma

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Anotácia

IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. 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. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows: a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER; b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3; c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares; d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017; e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT; f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS. LIEC 60601-2-54:2022 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM et des SYSTEMES EM destines a la RADIOGRAPHIE de projection et a la RADIOSCOPIE INDIRECTE. L’IEC 60601-2-43 est applicable aux APPAREILS EM et aux SYSTEMES EM destines a etre utilises lors de procedures d’interventions et se refere aux exigences applicables du present document. Les APPAREILS EM et SYSTEMES EM destines a l’osteodensitometrie par absorption, a la tomodensitometrie, a la mammographie ou aux applications dentaires ou de radiotherapie, sont exclus du domaine d’application du present document. Le domaine d’application du present document exclut egalement les simulateurs de radiotherapie. Lorsqu’un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, son titre et son contenu l’indiquent. Lorsque 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. LIEC 60601-2-54:2022 nnule et remplace la premiere edition parue en 2009, lAmendement 1:2015 et lAmendement 2:2018. Cette edition constitue une revision technique. La presente edition comprend des modifications techniques et redactionnelles destinees a representer l’IEC 60601 1:2005/AMD2:2020. Elle contient egalement des corrections et des ameliorations techniques. Les modifications techniques majeures par rapport a l’edition precedente sont les suivantes: a) deplacement en 201.3 des termes issus exclusivement de l’IEC TR 60788:2004 et qui sont specifiquement applicables dans le present document; b) si le FABRICANT le declare, les normes collaterales IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 et IEC 60601-1-12:2014/AMD1:2020 sappliquent; c) le paragraphe 201.11.101 “Protection contre les temperatures excessives des gaines equipees” a ete supprime du present document, car ses exigences sont suffisamment et clairement traitees par l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012, l’IEC 60601-1:2005/AMD2:2020 et l’IEC 60601-2-28:2017; d) clarification des exigences pour l’adoption des modifications introduites concernant les voyants lumineux au paragraphe 7.8.1 de l’IEC 60601-1:2005/AMD2:2020 afin d’eviter les conflits avec les exigences relatives aux voyants lumineux stipulees pour les APPAREILS A RAYONNEMENT X; e) explication du terme PERFORMANCE ESSENTIELLE fournie dans l’Annexe AA afin de mettre l’accent sur la fonction clinique en CONDITION NORMALE ET DE PREMIER DEFAUT.