Applicable to the product
Can be done by category, with the category can be done together, mainly to see the wavelength, wave Angle range, current, voltage, optical path, laser head specifications

 

The maximum possible effect (MPE) of the eye is measured in the light tree according to the risk of the laser to the human body, and is classified into four levels. Laser product manufacturers should attach the Class II, III and IV warning labels to the corresponding laser products.

Class I: Low output laser (power less than 0.4MW) does not exceed the MPE value for eyes and skin under any conditions, even when focused through an optical system. Typical applications include laser Pointers, CD players, CD-ROM equipment, geological exploration equipment and laboratory analysis instruments.

 

Class IIa: laser emits visible light radiation in the wavelength range of 400nm to 710nm. Laser radiation levels are considered harmless when exposure time does not exceed 1×103 seconds. However, exposure time exceeding 1×103 seconds is considered chronic visual hazard.

Class II: Low-output visible laser (power 0.4MW to 1mW), emitting visible light radiation in the wavelength range of 400 nm to 710 nm; The reaction time for closing the eyes is 0.25 seconds, with which the calculated exposure can not exceed the MPE value. Usually under 1mW laser, will cause dizziness can not think, with closed eyes to protect, can not be said to be completely safe, do not directly observe in the beam, do not use the Class II laser directly illuminate other people's eyes, avoid using farsighted equipment to observe the Class II laser. Typical applications include classroom demonstrations, laser Pointers, sighting equipment and range finders.

 

Class III: Medium output laser beam, if directly into the eye, will cause damage, for certain safety reasons, further classified as IIIa and IIIb.

IIIa is the continuous laser of visible light, with the output of 1-5MW laser beam, and the energy density of the beam should not exceed 25W/cm2. It is avoided to observe IIIa laser with far-sighted equipment, which may increase the risk. Typical IIIa applications have much in common with Class II, such as laser Pointers, laser scanners, etc.

Class IIIb continuous lasers of 5 to 500mW are dangerous to observe directly within the beam. However, the minimum irradiation distance is 13cm, and the maximum irradiation time is less than 10 seconds. Typical applications of IIIb lasers include spectroscopies and entertainment.

 

ClassIV: High output continuous laser (greater than 500mW), higher than level 3, fire hazard, diffusion reflection hazard. Typical applications include surgery, research, cutting, welding and micromachining.

 

Testing is introduced
The Food and Drug Administration (FDA) is one of the executive agencies established by the U.S. government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, the FDA is charged with ensuring the safety of food, cosmetics, drugs, biologics, medical devices and radiological products produced or imported into the United States. It was one of the first federal agencies to have consumer protection as its primary function.

 

Testing standard
FDA defines any product that contains circuitry and emits any type of radiation as an electronic radiation product, and products that contain these rays need to be submitted to FDA for annual registration. Regulation 21 CFR subpart J, Part 1000-1050 contains FDA regulations regarding the radiation safety of electronic radiation products, which must be followed by all manufacturers of electronic radiation products;

Manufacturers of laser products must meet the basic requirements of 21 CFR 1000-10005:

1000 - General requirements

1002 - Records and reports

1003 - Notification of defects and nonconformance

1004 - Buy back, repair or replace electronic products

1005 - Imports of electronic products

 

In addition, laser products must meet the laser safety performance standards of 21 CFR 1010 and 1040:

1010 - Performance standard for electronic products: General requirements

1040.10 - Laser products

1040.11 Specific purpose laser products

 

other
Information required for FDA registration of laser products:

1.FDA registration application form, application form: including company information, product information, etc.

2. Product documents/technical specifications Product documents/technical data: mainly including detailed description/sales manual, installation manual, maintenance manual, etc., product assembly drawing, product technical information, laser protection measures and working principle description.

3. Labels: English labels with warning marks, product labels, certification labels (e.g. 21 CFR 1040.10; 1040.11) and export labels, etc.

Warning labels are labels corresponding to laser grading. It gives a warning statement stating the laser specification and grade. The aperture label must be attached to the protective cover near the aperture of the laser that emits the laser. Here are some examples of such tags.

 

Watch out for labels:

Danger label:

 

 

4. Information: laser generator type, medium, the laser light path diagram, parameters of laser, laser equipment qualification certificate/test records (if purchased, from the other manufacturers need to provide the manufacturer's information, laser equipment parameters/data sheet or specification, and whether laser equipment have FDA certification/FDA number (if any).

5. Power meter calibration report

Certificate and report of annual measurement and validation of optical power meters.

6. Quality control system

Quality control documents: mainly including internal quality control flow chart, inspection procedure, quality control specification/design modification control, etc. Production line sampling list, incoming inspection list, finished product inspection list, internal inspection report, etc.

7. Us agents/importers

Us agent and US importer information: including contact name, phone/fax/email, US address/zip code, company name and US agent authorization agreement.