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额温枪体温计CE认证

摘要:  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 sa ...

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 一三九 二八九九 三九零七

https://www.iec.wiki/html/Thermometer

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