额温枪体温计CE认证

david

按照医疗适用的话，需要满足即将于2020年5月26日强制执行的EU MDR法规，此MDR于2017年已经发布，需要公告号机构发证书。

医用安规

• EN 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance
• EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• EN 60601-1-11 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• ASTM E1965 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
  

医用电磁兼容
EN 60601-1-2

医用性能
ISO 80601-2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
BS EN 12470-5:2003 Clinical thermometers. Performance of infra-red ear thermometers (with maximum device)

化学环保
ROHS2.0

实验室测试设备
EN 61010-1

检测认证与整改协助： 可以联系曾工 139 2899 3907

https://i.emc.wiki/Thermometer

DC_ltf

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