	Laser Standard

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.

FDA (CDRH) Structure Requirements

Protective Housing

Protective housing generally means housing of a product. This housing is to prevent the internal laser beam from leaking out (excluding its opening), and it must be able to maintain sufficient mechanical strength.

Safety Interlock

A safety interlock is required to be fixed on the protective housing in order to protect operators from being exposed to the internal laser beam while the protective housing is opened during operation or maintenance work.

Remote Interlock Connecter

The remote interlock connecter stops laser irradiation when the connector terminal is opened. It is intended to be used by connecting it to an emergency stop switch, etc. by the user.

Key Control

The key control function enables laser irradiation only when the key is switched to the "ON" position and it prohibits the irradiation if the key is not set to "ON". Furthermore, the key can only be removed when it is switched to the "OFF" position.

Controller Location

The controller location means that the laser product's operation control system is located at a safe place so that the operator is not directly exposed to the laser during an operation. This is to protect the operator from being exposed to the laser beam when operating laser products.

Emission Indicator

The emission indicator visually or audibly notifies its operator that the laser may be irradiated or has already been irradiated from the laser product. In the case of the visual method, it must be recognizable even when safety goggles are used.

Beam Attenuator

The beam attenuator electrically or mechanically interrupts the laser beam irradiated from a laser product. This function needs to be designed independently from the main power switch or key control of the laser product.

Scanning Safeguard

The scanning safeguard controls the laser products which come with a scanner so that AEL of the respective class is not exceeded by interrupting laser scanning, etc. when the laser scanner breaks down.

Manual Reset

With this manual reset function, laser irradiation can only be resumed manually when it is interrupted by the remote interlock connecter function. In other words, without a certain manual operation, the laser product continues to hold laser irradiation and never automatically resumes irradiation even if the remote interlock connecter is short-circuited again.

Identification Label/Certification Label

This label is required for the electrical products which are defined as "Radiological Health" products as described in Chapter J of 21CFE, and must include the name and address of the manufacturer, date of manufacture, and conformity to the requirements need to be specified. Below is an example of this label.

Caution Label/Danger Label

The caution label is required according to the laser class and warning message, and the laser specifications and laser class descriptions are specified. The danger label shows the opening of a protective housing from which the laser beam is irradiated. Below are examples of these labels.

Caution label

Danger label

FDA performance requirements for laser product

	ClassI	ClassIIa	ClassII	ClassIIIa	ClassIIIb	ClassIV
Protective housing	X	X	X	X	X	X
Safety interlock *1	△	△	△	△	△	△
Remote Interlock connector	-	-	-	-	X	X
Key control	-	-	-	-	X	X
Location of Control	-	X	X	X	X	X
Laser radiation emission indicator	-	-	X	X	X	X
Beam attenuator	-	-	X	X	X	X
Scanning safeguard *2	△	△	△	△	△	△
Manual reset mechanism	-	-	-	-	-	X
Identification label	X	X	X	X	X	X
Certification label	X	X	X	X	X	X
Warning logo type	-	-	X	X	X	X
Aperture label	-	-	X	X	X	X
Protective housing label *3	△	△	△	△	△	△


1.	Scanning Safeguard is required if the product incorporates the laser scanning system regardless of laser class.
2.	Safety interlock is required if the product has the protective housing which is designed to be removed or displaced during operation or maintenance.
3.	Protective housing label is required for each portion of the protective housing which has no safety interlock and which is designed to be displaced or removed during operation or maintenance.

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