IEC 60601-2-33:2022 医用电气设备.第2-33部分:医疗诊断用磁共振设备的基本安全和基本性能的特殊要求
标准编号：IEC 60601-2-33:2022
中文名称：医用电气设备.第2-33部分:医疗诊断用磁共振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 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
发布日期：2022-08-04
标准范围
IEC 60601-2-33:2022适用于磁共振（MR）设备和磁共振（MR）系统的基本安全和基本性能。本文件不涵盖MR设备超出预期用途的应用。如果一个条款或子条款特别旨在仅适用于MR设备或仅适用于MR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，则该条款或子条款适用于MR设备和MR系统。本文件未对介入MR检查中使用的MR设备或MR系统制定额外的具体要求。IEC 60601-2-33:2022取消并取代2010年发布的第三版、修正案1:20 13和修正案2:20 15。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)与IEC 60601-1:20 05及其两个修正案IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020保持一致；b)增加紧急现场停堆机组的安全要求；c)阐明患者和MR工作人员的声学保护措施；d)增加MR检查室内暴露的噪声排放声明，以支持负责机构的职业健康评估；e)增加射频线圈热安全的合规方法；f)添加RF发射定义以匹配医疗设备的MR条件标签要求；g)澄清附件MR条件标签的要求；h)B0危险区域的静态磁场限值与其他医疗器械标准（尤其是起搏器标准，ISO 14117）中的限值一致，新限值为0.9 mT；i)改进兼容性技术规格表(CTSS)中磁场相关图的描述；j)MR制造商为测试辅助设备提供兼容性序列（在CTSS中）已成为可选的，并且预计将在未来版本中被取消；k)包含安全信息的场地规划文件要求的单独部分；l)警报功能的要求（患者对操作者）；m)引入MROC作为1.5 T和3T系统的强制性功能，以促进使用标记为MR条件的医疗设备扫描患者，除非MR制造商明确禁止此类扫描；n)表201.A.102中的RF线圈符号已经成为强制性的，并且相对于先前版本，优选和替代符号已经互换，其中优选现在是带有颜色的符号；o）仅基于计算确定201.12.4.105.3.3中的B1杂散场
IEC 60601-2-33:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS.
This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant.
This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.
IEC 60601-2-33:2022 cancels and replaces the third edition published in 2010, Amendment 1:2013 and Amendment 2:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) aligned with IEC 60601-1:2005 and its two amendments IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) addition of safety requirements for the EMERGENCY FIELD SHUT DOWN UNIT;
c) clarification of acoustic protection measures for the PATIENT and MR WORKER;
d) addition of noise emission declaration for exposure inside the MR EXAMINATION ROOM, to support occupational health assessment by the RESPONSIBLE ORGANIZATION;
e) addition of compliance methods for thermal safety of RF coils;
f) addition of RF transmit definitions to match MR CONDITIONAL labelling requirements for MEDICAL DEVICES;
g) clarification of requirements for MR CONDITIONAL labelling of ACCESSORIES;
h) alignment of static magnetic field limit for B0 HAZARD area to limits in other MEDICAL DEVICE standards (especially that for pacemakers, ISO 14117), the new limit value being 0,9 mT;
i) improved description of the magnetic field related plots in the Compatibility Technical Specification Sheet (CTSS);
j) provision of compatibility sequences (in the CTSS) to test auxiliary equipment by the MR manufacturer has become optional, and is expected to be eliminated in a future edition;
k) a separate section with requirements for a site-planning document containing safety information;
l) requirements for the alerting function (PATIENT to OPERATOR);
m) introduction of MROC as mandatory functionality for 1,5 T and 3 T systems to facilitate scanning of PATIENTs with MEDICAL DEVICES labelled as MR CONDITIONAL, unless such scanning is explicitly contra-indicated by the MR MANUFACTURER;
n) RF coil symbols in Table 201.A.102 have become mandatory, and the preferred and alternate signs have been swapped relative to the previous edition, with preferred now being the sign with color;
o) determination of the B1 stray field in 201.12.4.105.3.3 based on calculations only
标准预览图
