Electronic Product Radiation Control Program | FDA
2023年2月23日 · FDA is responsible for regulating radiation-emitting electronic products. The agency's goal is to protect the public from hazardous and unnecessary exposure to radiation …
Labeling Requirements for Radiation Emitting Devices and …
Labeling of radiation-emitting products applies to all products which emit sonic, infrasonic, or ultrasonic radiation as the result of operation of an electronic...
Electronic Product Radiation Control (EPRC) Variance Application
On September 1, 2020, the FDA’s Center for Devices and Radiological Health (CDRH) updated the Electronic Product Radiation Control (EPRC) variance application process. For more …
FDA关于X射线设备和IEC标准的指南：DoC、认证和信息共享 - 知乎
2023年3月22日 · 根据21 CFR 1010.2（a）法规的规定，适用的EPRC性能标准对诊断x射线系统及其主要部件有效，包括符合适用IEC标准以满足EPRC性能要求的部件，其制造商必须为其产 …
Manufacturers and importers of medical x-ray imaging equipment must follow the current EPRC regulations and procedures or provide a declaration of conformity to equivalent IEC standards, …
对美国FDA电子产品辐射控制 (EPRC)监管体系的调查分析_百度文库
对美国FDA电子产品辐射控制 (EPRC)监管体系的调查分析-由美国食品药品监督管理局 (Foodand Drug Administration,文中简称FDA)制定的监督管理法规具有很高的水平,堪称是世界上最为完善 …
Radiation Emitting Devices and Products ... - Freyr Solutions
2023年7月25日 · Any receiver that emits more radiation than the minimum requirement due to component failure or poor adjustment must include a permanently affixed or inscribed warning …
对美国FDA电子产品辐射控制_EPRC_监管体系的调查分析 - 豆丁网
( 对美国 F D A 电子产品辐射控制 ( E P R C) 监管体 ) ( 系的调查分析 ) ( 文章编号： 1006-6586 (2008)12-0030-05 中图分类号： R 141 ) ( 文献标识码： A ) ( 在 现 代 社 会 中 ， 电 子 产 品 …
Electronic Product Radiation Control Program: Industry Guidance
2024年9月27日 · This page contains a listing of guidances for the FDA's Electronic Product Radiation Control Program.
FDA 2877 Declaration for Imported Electronic Products Subject to
Any person importing a non-compliant electronic NAME AND TITLE OF RESPONSIBLE PERSON product may also be subject to civil penalties of $1000 per violation, up to a …