Emitech comble le vide normatif sur la CEM des dispositifs médicaux 5G et Wi-Fi 6E/7
法国测试集团 Emitech 近日开始为医疗设备提供 6 GHz 以上频段的辐射抗扰度测试，重点覆盖当前标准尚未纳入的频段，以填补医疗器械电磁兼容（CEM）领域的规范空白。该举措主要面向搭载 5G、Wi‑Fi 6E/7 等新一代无线通信能力的医疗设备，因为这些产品在更高频段下的电磁抗扰能力，尚未被现行测试标准充分覆盖。
Emitech 此举的核心目标，是提前对齐美国食品药品监督管理局（FDA）未来可能提出的要求，帮助客户在医疗设备进入美国市场前完成更充分的合规验证，从而降低上市风险。对于希望在美国销售联网医疗设备的厂商而言，这意味着可以更早识别潜在的电磁兼容问题，避免在认证、注册或商业化阶段遭遇延误。
从行业背景看，随着 5G 和 Wi‑Fi 6E/7 在医疗场景中的应用增加，医疗设备不仅要满足传统 CEM 要求，还必须应对更高频无线环境带来的干扰挑战。但现有标准对 6 GHz 以上频段的覆盖仍存在缺口，Emitech 的测试服务正是针对这一空白推出，属于面向未来监管趋势的前置性能力建设。
Emitech is now testing the radiated immunity of medical devices above 6 GHz, a frequency range that is not covered by current standards. The French testing and certification group is moving to fill a regulatory gap that has become increasingly relevant as medical equipment incorporates 5G and Wi‑Fi 6E/7 connectivity.
The goal is to anticipate the expectations of the U.S. Food and Drug Administration (FDA) and help customers secure the launch of their medical devices on the American market. By extending electromagnetic compatibility (EMC) testing into this higher-frequency band, Emitech aims to support manufacturers facing a standards landscape that has not yet fully caught up with the latest wireless technologies.
The move positions Emitech as a preparatory partner for companies developing connected medical equipment, especially those that need to demonstrate robustness against interference in environments where 5G and next-generation Wi‑Fi signals are present.
Le groupe français teste désormais l’immunité rayonnée des dispositifs médicaux au-delà de 6 GHz, une plage non couverte par les normes actuelles. L’objectif est d’anticiper les attentes de la Food and Drug Administration (FDA) et ainsi d’aider ses clients à sécuriser le lancement de leurs équipements médiaux sur le marché américain. Le groupe français Emitech, […]
Cet article Emitech comble le vide normatif sur la CEM des dispositifs médicaux 5G et Wi-Fi 6E/7 a été publié par VIPress.net.
Emitech is extending radiated immunity testing for medical devices beyond 6 GHz to fill a regulatory gap for 5G and Wi‑Fi 6E/7, helping clients meet anticipated FDA expectations for US market launches.
Emitech — French EMC testing group expanding radiated immunity validation for medical devices; based in France.
FDA — US regulator setting/anticipating medical device electromagnetic compatibility expectations; United States.
[Strongly track] — regulatory/standards coverage beyond 6 GHz is a near-term blocker for US launches of 5G/Wi‑Fi 6E/7 medical devices.