IEC 60601-1-2:20 14适用于存在电磁干扰的医疗设备（ME）设备和ME系统的基本安全和基本性能，以及ME设备和ME系统发出的电磁干扰。本IEC 60601-1的附属标准规定了电磁干扰和电磁辐射设备和电磁辐射的基本安全和基本性能的一般要求和试验。它们是对通用标准IEC 60601-1要求的补充，并作为特定标准的基础。本第四版取消并取代了IEC 60601-1-2的第三版，构成技术修订。与上一版本相比，最显著的变化包括以下修改:-根据预期使用环境的抗扰度测试水平规范，根据与IEC 60601-1-11协调的位置分类:专业医疗保健设施环境、家庭医疗保健环境和特殊环境； -当便携式射频通信设备比基于第三版中规定的抗扰度测试水平建议的更靠近医疗电气设备时，为提高医疗电气设备和医疗电气系统的安全性而规定的测试和测试水平； -根据医疗电气设备或医疗电气系统的端口规定抗扰度测试和抗扰度测试水平； -基于预期使用环境中可合理预见的最大电磁干扰水平的抗扰度测试水平规范，导致某些抗扰度测试水平高于上一版本；和 -更好地与基本安全和基本性能的风险概念相协调，包括删除定义的"维持生命"一词。此新版本包括以下主要新增内容: -特殊环境抗扰度测试水平确定指南； -当缓解或预期用途的特殊考虑适用时，调整抗扰度测试水平的指南； -关于电磁干扰的基本安全和基本性能的风险管理指南；和 -关于确定免疫通过/失败标准的指导。

IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;
- specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition;
- specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system;
- specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and
- better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions:
- guidance for determination of immunity test levels for special environments;
- guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable;
- guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and
- guidance on identification of immunity pass/fail criteria.