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【FDA注册】激光产品出口FDA注册知识详解
美国食品和药物管理局(FDA)规范管理全部在国外市场销售的激光产品。生产商务必验证她们的激光产品合乎美国政策法规和激光性能规范[21 CFR 1040.10 and 1040.11]。激光的性能规范适用全部在国外市场销售的激光产品[21 CFR 1040.10(a)]。需需注意的, 英国FDA并不“验证”或准许非诊疗激光产品。一
2021/08/24

美国食品和药物管理局(FDA)规范管理全部在国外市场销售的激光产品。生产商务必验证她们的激光产品合乎美国政策法规和激光性能规范[21 CFR 1040.10 and 1040.11]。激光的性能规范适用全部在国外市场销售的激光产品[21 CFR 1040.10(a)]。

需需注意的, 英国FDA并不“验证”或准许非诊疗激光产品。


一、辐射发射商品FDA认证

“辐射操纵规章”(于1968年施行,做为“身心健康和安全性辐射控制法”)坐落于该法第531至542条,他们适用一切“电子设备”,其界定为一切生产制造或拼装的商品(或该类商品的部件,构件或配件),在运作时

(1)包括或做为电子线路的一部分,

(2)发射电子设备辐射(或在沒有合理屏蔽掉或别的操纵的状况下)。


二、必须向FDA進口单位递交什么材料?

合乎FDA性能规范的辐射发射电子设备的采购商务必根据向相对应的FDA進口公司办公室递交FDA 2877“辐射操纵规范商品通告”和别的书面形式進口申报信息,不符可用性能规范或含有没贴在每一个商品上的验证标识或标识(21 CFR 1010.2)的辐射电子设备应予以拒绝接收,假如您的商品合乎性能规范,说明您已向FDA汇报商品的一种方式 是在FDA 2877报表中添加准入条件号。

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三、电子设备辐射界定为:

(A)一切水解或者非水解的电磁感应或颗粒辐射

(B)因为商品中电子线路的实际操作而从电子设备传出的一切声波频率,次声或超音波响声。


四、激光FDA发亮商品性能规范:

(1)可做到的发射水平就是指依据这节(e)段精确测量的特殊光波长和特殊光波长发射延迟时间的可完成的激光或平行面辐射,如该一部分的,可贴近的激光或附加辐射是身体可贴近的辐射。

(2)可做到的排出限制值是与立要求的特殊额定电流所容许的可做到的排出水平。

(3)I类激光产品是激光辐射水平,在一切激光产品的操作流程中,一切激光产品不可贴近中表I列出的一切可做到的发射限制值。

(4)IIa类激光产品就是指容许作业者进到超出表I要求的可做到的发射限制值的由此可见激光辐射水平的一切激光产品,但不允许工作人员在实际操作期内贴近激光辐射水平。

(5)II类激光产品就是指在操作流程中容许工作人员进到由此可见激光辐射水平高过表II-A要求的可做到的发射限制值的激光产品,但不允许工作人员在实际操作期内触碰激光辐射水平超出这节(d)表2中列举的排出限制值。

(6)IIIb类激光产品就是指在操作流程中容许工作人员进到超出表III-A可做到的发射限制值的激光辐射水平但不允许工作人员在实际操作期内贴近激光辐射水平的一切激光产品。


五、激光FDA认证必须给予下列信息内容:

1.申请表格

2.英语指南

3.原理图

4.PCB合理布局

5.个零件明细

6.规格型号或JAQ汇报,包含激光光波长范畴。

7.激光途径图

8.标识电子文件

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