Performance Requirements [21 CFR 1040.10(f)]
性能要求[21 CFR 1040.10(f)]
The laser performance standard specifies performance requirements according to the Class of the laser product and the accessible laser radiation. In the table below, each Class a particular performance standard applies to is marked with an “X”; regarding “*,” please refer to Laser Notices #43 and 49 for clarification of requirements.
根据激光类产品的分类和激光辐射, 激光性能规定如下. 在下面的表格中, “X”标记指适用于激光性能; “*”标记请参阅第43和49号激光通告的要求.
Class I
Class II
Class IIIa
Class IIIb
Class IV
I级
II级
IIIa级
IIIb级
IV级
A protective housing [21 CFR 1040.10(f)(1)]
保护罩
Safety interlocks [21 CFR 1040.10(f)(2)]
联锁
X
Remote interlock connector [21 CFR 1040.10(f)(3)]
遥控互锁连接器
X
Key control [21 CFR 1040.10(f)(4)]
按键控制

Laser radiation emission indicator [21 CFR 1040.10(f)(5)]
激光辐射指标器

Beam attenuator [21 CFR 1040.10(f)(6)]
光束衰减器

Location of controls [21 CFR 1040.10(f)(7)]
控制器位置
X
Viewing optics [21 CFR 1040.10(f)(8)]
观察光学器件

Scanning safeguard [21 CFR 1040.10(f)(9)]
扫描装置
XX
Manual reset mechanism [21 CFR 1040.10(f)(10)]
手动复位机制

激光仪FDA年审请联系我们

我们的FDA范围广， 更专业， 更**

1.FDA食品类，酸性食品FDA，罐头食品FDA

2. FDA激光辐射类，  FDA激光产品年报

3. FDA器械类   FDA510K

4. FDA化妆品类

5 .FDANDC