IEC 60601-2-43:2022 医用电气设备.第2-43部分:介入手术用X射线设备的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-43:2022

中文名称：医用电气设备.第2-43部分:介入手术用X射线设备的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

发布日期：2022-12-05

标准范围

IEC 60601-2-43:2022作为IEC 60601-2-43:2022 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 60601-2-43:2022适用于制造商声明适用于放射镜引导介入手术的固定式和移动式X射线设备（以下简称介入X射线设备）的基本安全和基本性能。其范围尤其不包括:-放射治疗设备；-计算机断层扫描设备；-旨在引入患者体内的附件；-乳房X光摄影设备；-牙科X光设备。制造商声明适用于放射镜引导介入手术的介入X射线设备，如果不包括作为系统一部分的患者支撑，则不受本文件患者支撑条款的约束。如果某条款或子条款特别旨在仅适用于介入X射线设备或仅适用于ME系统，则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介入X射线设备和ME系统。IEC 60601-2-54仅适用于引用的子条款；IEC 60601-2-54的未引用子条款不适用。IEC 60601-2-43:2022取消并取代2010年发布的第二版、修正案1:20 17和修正案2:20 19。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和IEC 60601-2-54:2022。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IEC 60601-2-54:2022中的通用术语剂量计；b)从IEC TR 60788:2004移至IEC 60601-2-54:2022的201.3的几个术语和定义也参考自IEC 60601-2-54:2022。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)删除原子条款201.11.101“X射线管组件的过温防护”，因为该条款由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涵盖，原子条款201.11.102重新编号为201.11.101，与IEC 60601-2-54:2022相同；e)采用IEC 60601 1中第7.8.1款“指示灯颜色”的变更:2005/AMD2:2020，201.7.8.1中提供了要求澄清，以避免与IEC 60601-2-54:2022中规定的X射线设备指示灯要求冲突；f）附录AA中提供了术语基本性能的解释，以强调正常条件和单故障条件下临床功能的性能。

IEC 60601-2-43:2022 is available as IEC 60601-2-43:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-43:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X RAY EQUIPMENT;
- dental X RAY EQUIPMENT.
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY 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 INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. 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 as in IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2004 to 201.3 of IEC 60601-2-54:2022 are also referenced from IEC 60601-2-54:2022.
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 former subclause 201.11.101 “Protection against excessive temperature of X-RAY TUBE ASSEMBLIES” is removed since covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017, and the former subclause 201.11.102 is renumbered as 201.11.101, as in IEC 60601-2-54:2022;
e) to adopt changes in subclause 7.8.1 “Colours of indicator lights” in IEC 60601 1:2005/AMD2:2020, clarification of requirements is provided in 201.7.8.1 to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT, as in IEC 60601-2-54:2022;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.

标准预览图