Labeling Requirements [21 CFR 1040.10(g)]
标签要求 [21 CFR 1040.10(g)]
The laser performance standard specifies labeling requirements according to the Class of the laser product. Labeling requirements specified in the laser standard include:
激光性能对标签的要求是基于激光产品的分类, 其中包括：
1. A certification label is required [21 CFR 1010.2] for all products and must state that the product
1. 所有激光产品必须要有认证标签[21 CFR 1010.2],
5
complies with the laser performance standard or with an approved variance. The certification statement must appear on the product and reference the regulations with which the product complies. Minimum suitable statements would include: "Complies with 21 CFR Chapter 1, Subchapter J." or "Complies with 21 CFR 1040.10 and 1040.11."
并须注明该产品符合激光性能或经批准的特许. 认证声明必须出现在产品上, 并引用该产品遵循的法规. 恰当的短声明将包括: "Complies with 21 CFR Chapter 1, Subchapter J." or "Complies with 21 CFR 1040.10 and 1040.11." 对应中文是:“遵循美国联邦法规21第1章J节” 或“遵循美国联邦法规21第1040.10和1040.11节.”
2. The manufacturer’s identification label [21 CFR 1010.3] is required for all products and must include the name and address of the manufacturer and the place, month, and year of manufacture. A manufacturer may also include the certification statement [21 CFR 1010.2] on this label.
2. 所有产品都需要有制造商的识别标签[21 CFR 1010.3], 其中包括制造商的名称, 地址, 产地和生产日期. 一个制造商还还可以在这个标签中加入认证声明[21 CFR1010.2].
3. A warning logotype [21 CFR 1040.10(g)(1),(2),(3)] is required on Class II, IIIa, IIIb, and IV laser products.
3. 激光产品分类第II级, III, IIIB级, 和IV级的产品需要警告标识[21 CFR 1040.10(g)(1),(2),(3)].
4. Labels for noninterlocked protective housings [21 CFR 1040.10(g)(6)] and labels for interlocked protective housings that can be defeated [21 CFR 1040.10(g)(7)].
4. 对于没有互锁保护罩[21 CFR 1040.10(g)(6)] 或有可能失效的互锁防护罩[21 CFR 1040.10(g)(7)], 需要有标签注明.
5. Warning for visible or invisible radiation [21 CFR 1040.10(g)(8)].
5. 无论是可见或不可见的辐射, 要给予警告 [21 CFR 1040.10(g)(8)].
6. An aperture warning label is required for each aperture through which laser radiation in exceeds Class I during operation [21 CFR 1040.10(g)(5) or 1040.11(a)(3)].
6. 对于在操作中激光辐射超过第I级的每一个光孔都需要有一个光孔警告标签 [21 CFR 1040.10(g)(5) or 1040.11(a)(3)].
All required labels must be permanently affixed and must be legible. Laser Notice 53 identifies situations in which CDRH believes alternate means of providing the required information are appropriate (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidancedocuments/ucm094371.htm).
所需的所有标签必须固定，清晰可辨。关于激光的第53号通知中明确了在何种情况下, 可用替代提供所需信息. (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidancedocuments/ucm094371.htm).

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