FDA辐射类电子产品的检测标准

辐射类电子产品的种类有:

医疗;X- mso-hansi-font-family:"Times New Roman"">射线诊断仪, "Times New Roman"">超声波图像仪, "Times New Roman"">微波或超声辐射热治疗仪, "Times New Roman"">微波辐射血液加热器或灭菌器, "Times New Roman"">激光辐射凝固器;

非医疗; mso-hansi-font-family:"Times New Roman"">微波炉, "Times New Roman"">电视接收机和监视器( "Times New Roman"">显示器),演示用激光器, mso-hansi-font-family:"Times New Roman"">工业用X "Times New Roman"">射线系统,无绳或蜂窝移动电话, mso-hansi-font-family:"Times New Roman"">工业用RF "Times New Roman"">多层塑料材料封口机器, "Times New Roman"">激光CD播放机;

电子产品辐射定义为:

     任何电离的或非电离的电磁辐射, mso-hansi-font-family:"Times New Roman"">或特指的辐射;

     电子产品工作时从电子线路中产生的音频, mso-hansi-font-family:"Times New Roman"">次声, "Times New Roman"">超声波的辐射.

性能标准概要

21CFR1020.10 "Times New Roman"">电视接收机

适用于接收信号并将信号转换成电视图像信号的接收机和显示器.

辐射值为: mso-hansi-font-family:"Times New Roman"">使接收机的用户调节旋钮和维修装置于最大状态下以及在一个组件实效的最坏的故障状态下, mso-hansi-font-family:"Times New Roman"">距离显像管表面5CM "Times New Roman"">处的射线不能超过0.5MR-hr.

21CFR1020.20 "Times New Roman"">冷阴极射线放电管

30CM "Times New Roman"">处的射线不能超过0.5Mr-hr.

要求有用户警告卷标.

21CFR1020.30 X "Times New Roman"">射线诊断仪及其主要部件

距离放射源1 mso-hansi-font-family:"Times New Roman"">米处的射线泄漏一小时这内不能超过100MR, mso-hansi-font-family:"Times New Roman"">对于其它部件,5CM "Times New Roman"">处的射线泄漏一小时这内不能超过2MR.

违反辐射管理法规将采取的措施

A.FDA "Times New Roman"">将采取的管理措施

1; "Times New Roman"">要求召回产品( "Times New Roman"">纠正措施要获批准和证实);

2; "Times New Roman"">不批准质量控制和测试计划( "Times New Roman"">即,禁止该产品出口);

3;( "Times New Roman"">与美国海关一同) "Times New Roman"">实施进口警戒, "Times New Roman"">自动扣留或阻止进口;

B. mso-hansi-font-family:"Times New Roman"">通过美国地方法院采取的措施                      

1; "Times New Roman"">发布禁令禁止跨州商业运输该商品或要求提供报告和证书;

2; "Times New Roman"">对于违反报告的规定, "Times New Roman"">违反认证的规定和不满足标准要求以处罚( "Times New Roman"">罚款);