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Laser Standard (FDA)

FDA(CDRH)Structure Require

FDA laser product

Laser Standard (FDA)

FDA 21CFR Part 1040.10 (CDRH)

Summary of requirements according to FDA

 

Classification

Outline of risk assessment

Class I

Levels of laser radiation are not considered to be hazardous.

Class IIa

Levels of laser radiation are not considered to be hazardous if viewed for any period of time less than or equal to 1 x 103 seconds.

Class II

Levels of laser radiation are considered to be a chronic viewing hazard.

Class IIIa

Levels of laser radiation are considered to be, depending upon the irradiance, either an acute intrabeam viewing hazard or chronic viewing hazard, and an acute viewing hazard if viewed directly with optical instruments.

Class IIIb

Levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct radiation.

Class IV

Levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct and scattered radiation.

2011-4-22

 

   
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