标准摘要
[中文适用范围]： IEC 61326-2-6:2025适用于体外诊断医用电气设备（IVD MEE）的基本安全和基本性能。本部分规定了IVD MEE在电磁干扰存在下的基本安全与基本性能，以及IVD MEE所产生的电磁干扰。关于电磁干扰的基本安全要求适用于所有IVD MEE。 注1：除基本性能外，对其他电磁干扰下的性能要求见IEC 61326-1:2020。 注2：信息技术设备若为维持基本安全或基本性能所必需，可成为IVD MEE的一部分。 本版相较于前一版包含以下重要技术变更：- 更新了测试水平及相关文件要求。 [外文原描述]： IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE. BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE. NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020 NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE. This edition includes the following significant technical changes with respect to the previous edition: - Update of the document with respect to test levels and documentation.
英文名称Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment