IEC 60601-2-54:2022
(Main)Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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.
Appareils électromédicaux - Partie 2-54: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie
IEC 60601-2-54:2022 est disponible sous forme de IEC 60601-2-54:2022 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-54:2022 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM et des SYSTEMES EM destinés à la RADIOGRAPHIE de projection et à la RADIOSCOPIE INDIRECTE. L’IEC 60601-2-43 est applicable aux APPAREILS EM et aux SYSTEMES EM destinés à être utilisés lors de procédures d’interventions et se réfère aux exigences applicables du présent document. Les APPAREILS EM et SYSTEMES EM destinés à l’ostéodensitométrie par absorption, à la tomodensitométrie, à la mammographie ou aux applications dentaires ou de radiothérapie, sont exclus du domaine d’application du présent document. Le domaine d’application du présent document exclut également les simulateurs de radiothérapie. Lorsqu’un article ou un paragraphe est spécifiquement destiné à être 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 à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. L'IEC 60601-2-54:2022 nnule et remplace la première édition parue en 2009, l'Amendement 1:2015 et l'Amendement 2:2018. Cette édition constitue une révision technique. La présente édition comprend des modifications techniques et rédactionnelles destinées à représenter l’IEC 60601 1:2005/AMD2:2020. Elle contient également des corrections et des améliorations techniques. Les modifications techniques majeures par rapport à l’édition précédente sont les suivantes:
a) déplacement en 201.3 des termes issus exclusivement de l’IEC TR 60788:2004 et qui sont spécifiquement applicables dans le présent document;
b) si le FABRICANT le déclare, les normes collatérales 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 s'appliquent;
c) le paragraphe 201.11.101 “Protection contre les températures excessives des gaines équipées” a été supprimé du présent document, car ses exigences sont suffisamment et clairement traitées 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’éviter les conflits avec les exigences relatives aux voyants lumineux stipulées 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.
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IEC 60601-2-54
®
Edition 2.0 2022-09
REDLINE VERSION
INTERNATIONAL
STANDARD
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Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-54:2022-09 RLV(en)
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IEC 60601-2-54
®
Edition 2.0 2022-09
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.50 ISBN 978-2-8322-5784-5
Warning! Make sure that you obtained this publication from an authorized distributor.
® Registered trademark of the International Electrotechnical Commission
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– 2 – IEC 60601-2-54:2022 RLV © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
INTRODUCTION TO AMENDMENT 1 .
INTRODUCTION TO AMENDMENT 2 .
201.1 Scope, object and related standards . 9
201.2 Normative references . 11
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARD
...
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