IEC 60601-2-54:2022 RLV包含官方IEC国际标准及其红线版本。Redline版本仅提供英文版本，为您提供了一种快速简单的方法来比较IEC官方标准与其以前版本之间的所有变化。 IEC 60601-2-54:2022适用于拟用于投影射线照相术和间接射线照相术的ME设备和ME系统的基本安全和基本性能。IEC 60601-2-43适用于预期用于介入应用的ME设备和ME系统，并参考了本文件中的适用要求。预期用于骨或组织吸收密度测定、计算机断层扫描、乳腺X线摄影或牙科或放射治疗应用的ME设备和ME系统不在本文件范围内。本文件的范围也不包括放射治疗模拟器。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。IEC 60601-2-54:2022版取消并取代2009年发布的第一版、修正案1:20 15和修正案2:20 18。本版构成技术修订版。本版本包括编辑和技术变更，以反映IEC 60601 1:20 05/AMD2:2020。它还包含更正和技术改进。与上一版相比的重大技术变更如下: a)引入新的特定术语剂量计以取代一般术语剂量计；b)专门取自IEC TR 60788:2004且在本文件中特别适用的术语和定义已移至201.3； c)如果制造商声明，则附属标准IEC 60601-1-11:20 15、IEC 60601-1-11:20 5/AMD1:2020、IEC 60601-1-12:20 14和IEC 60601-1-12:20 4/AMD1:2020适用； d)由于IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012、IEC 60601-1:20 05/AMD2:2020和IEC 60601-2-28:2017充分且明确地涵盖了子条款201.11.101“X射线管组件过热防护”已从本文件中删除； e)采用IEC 60601-1:20 05/AMD2:2020 7.8.1中对指示灯引入的变更。提供要求澄清，以避免与X-规定的指示灯要求发生冲突。射线设备； f）附录AA中提供了术语基本性能的解释，以强调正常和单故障条件下临床功能的性能。条件。

IEC 60601-2-54:2022 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its 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.