额温枪体温计CE认证

2020-8-10 22:52| 发布者: zxw| 查看: 4104| 评论: 1|原作者: david|来自: 电磁兼容网

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 139 2899 3907
https://wiki.dzfa.com/html/Thermometer

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额温枪体温计CE认证

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