Safety Standards for Laser Beams

Class	Overview of hazard evaluation
Class 1	Laser products that are safe under any reasonably foreseeable operating conditions, even when viewed with loupes, binoculars, or other optical viewing instruments. Laser products that emit visible light may still produce dazzling visual effects.
Class 1M	Laser products that are safe under any reasonably foreseeable operating conditions when viewed with the naked eye. Under certain conditions, the use of optical instruments may result in eye injury.
Class 1C	Laser products that are safe for direct laser irradiation of body tissue other than the eye area for medical and beauty care applications. The emitted laser beam may be on the level of Class 3R, 3B, or 4 and there is potential danger to the target tissue.
Class 2	Laser products that are normally safe for momentary exposure due to the protection afforded eyes by aversion reactions, such as blinking, but that can be dangerous if someone deliberately looks into the beam. Caution is required for visual impairments caused by residual images or reflection actions caused by surprise.
Class 2M	Same as Class 2 for the naked eye: Laser products that are normally safe for momentary exposure due to the protection afforded eyes by aversion reactions, such as blinking, but that can be dangerous if someone deliberately looks into the beam. Caution is required for visual impairments caused by residual images or reflection actions caused by surprise. Under certain conditions, the use of optical instruments may result in eye injury.
Class 3R	The risk of injury is less than Class 3B for direct intrabeam exposure. Intentional ocular exposure is dangerous. Caution is required for visual impairments caused by residual images or reflection actions caused by surprise.
Class 3B	Even accidental short-term ocular exposure to the beam is normally dangerous. Under certain conditions, minor skin injury or combustion of flammable materials is possible.
Class 4	Intrabeam viewing and skin exposure are dangerous. There is also a risk of fire.

Laser Classifications

The safety standards for laser beams are different for each country and region. The definitions for laser classifications in Europe and the United States are described below.

Europe (EN 60825-1)

The classification standards set forth in European Standard EN 60825-1:2014 is consistent with the JIS standard C6802:2014.
You should always check the original text of the standard when trying to attain conformance.

USA

* The following information was edited by OMRON based on the actual standard. OMRON assumes no responsibility for this information. You should always check the original text of the standard before implementing an actual application.
* Filing is required for laser products for the USA. Select products that have been filed with the FDA (U.S. Food and Drug Administration).
* Currently the USA is preparing to adopt the IEC 60825-1 international standard, which was harmonized between the EU and JIS. During the provisional period, the classifications and labeling of IEC will be approved (Laser Notice No.50). For details refer to Laser Notice No.50 and to the IEC Standards.
Some OMRON products are classified by the standards given in Laser Notice No.50. Others are classified by the FDA standards.

	Description of FDA classification definition
Class I	Considered nonhazardous.
Class IIa	Products that have emissions in the visible spectrum (400 to 710 nm) and that are nonhazardous for viewing durations up to 1,000 s. Viewing for longer than 1,000 s presents the risk of chronic visual impairment.
Class II	Products that have emissions in the visible spectrum and that have an emission power of more than 1 mW for continuous discharge of more than 0.25 s. Viewing the laser beam presents the risk of chronic visual impairment.
Class IIIa	Products that have emissions in the visible spectrum and that have an emission power of more than 5 mW for continuous discharge of more than 0.38 ms. Irradiance presents the risk of acute or chronic visual impairment resulting from viewing the beam. Directly viewing the laser beam with an optical instrument presents the risk of acute visual impairment.
Class IIIb	Products that emit laser beams of any wavelengths, for example products that emit visible light with an emission power of 5 to 500 mW. Direct contact with the light beam presents the risk of acute visual impairment or skin damage.
Class IV	Products that exceed the limits of Class IIIb and that present a risk for visual impairment or skin damage for scattered (diffuse) reflection as well as for direct exposure.

Measures for the Prevention of Damage due to Laser Beams

Regarding labor using lasers, the Industrial Safety and Health Law sets out specific details of safety measures for laser equipment that are classified as Class 3R or higher in Measures for the Prevention of Damage due to Laser Beams. The following table gives the criteria for the measures by each class.

Measure (item only)			Measure	Class of laser equipment
Measure (item only)			Measure	4	3B	3R	2M	1M
Appointment of a laser device manager			Appoint an individual with sufficient knowledge and experience regarding the prevention of damage due to laser beams and the handling of laser equipment.	Yes	Yes	Yes
Controlled area (signs and restricted area)			Partition from other areas, indicate the partition with signs, and prohibit entry to unauthorized personnel.	Yes	Yes
Laser equip- ment	Path of laser beam	Position of path	Avoid eye level of the operator.	Yes	Yes	Yes	Yes	Yes
		Appropriate design and blocking of path	Keep the path as short as possible, minimize the number of bends, avoid intersections of light with pathways, and block light paths as much as possible.	Yes	Yes	Yes
		Proper termination	Terminate with diffuse reflection objects or light absorbing objects that have appropriate reflectance and heat resistance.	Yes	Yes	Yes	Yes	Yes
	Key control		Use a construction where operation is enabled by key or similar means.	Yes	Yes
	Emer- gency stop switches, etc.	Emergency stop switches	Provide an emergency stop switch that can be used to immediately stop laser-beam emission.	Yes	Yes
		Warning system	Provide a warning system with features that allow easy confirmation, such as indicators that light automatically.	Yes	Yes	Yes
		Shutter	Provide the emission aperture with a shutter to prevent accidental emission.	Yes	Yes
	Interlock system, etc.		Ensure that laser-beam emission is stopped automatically when the controlled area becomes accessible or the beam patch is unblocked.	Yes	Yes
	Indication of emission aperture		Indicate the laser-beam emission aperture.	Yes	Yes	Yes
Work man- agement, etc.	Operating position		Perform control of laser equipment from a position as far away as possible form the laser-beam path.	Yes
	Adjustment of optical system		Use the minimum amount of power that is required when adjusting the optical system.	Yes	Yes	Yes	Yes	Yes
	Protec- tive equip- ment	Protective glasses	Wear protective glasses appropriate for the type of laser used.	Yes	Yes	Yes
		Protective clothing	Wear clothing that allows only minimum skin exposure.	Yes	Yes
		Use of flame- retardant materials	Wear clothing made of flame-retardant materials. Synthetic fibers that melt and become sphere-shaped are unsuitable.	Yes
	Inspections and maintenance		Perform inspections before operation and regular inspections and adjustments at fixed intervals.	Yes	Yes	Yes	Yes	Yes
	Safety and health education		Provide training when taking on new personnel, and when changing the work procedure or the laser equipment.	Yes	Yes	Yes	Yes	Yes
	Health- care	Examinations of anterior ocular segment	Administer cornea and lens examinations together with eyesight examinations when taking on or transferring personnel.	Yes	Yes	Yes
	Health- care	Examinations of the ocular fundus	Administer ocular-fundus examinations together with eyesight examinations when taking on or transferring personnel.	Yes
Others	Notifica- tion	Supervisor's name	Provide notification of the laser-equipment supervisor's name.	Yes	Yes	Yes
		Level of the hazard indication	Provide notification regarding the risks and harmful effects of laser beams, as well as handling precautions in an obvious location.	Yes	Yes	Yes	Yes	Yes
		Installation	Provide signs that indicate the presence of laser-equipment.	Yes	Yes
	High voltage display		Provide indication of high voltages and implement measures for preventing electric shock.	Yes	Yes	Yes	Yes	Yes
	Prohibi- tion of hazard- ous objects	In controlled areas	Prohibit explosive and flammable substances.	Yes
	Prohibi- tion of hazard- ous objects	Close to path of laser beam	Prohibit explosive and flammable substances.	Yes	Yes
	Hazardous gases and dusts		Implement the measures prescribed by the Industrial Safety and Health Law.	Yes	Yes
	Examination and treatment of personnel with suspected laser-related injury by medical professional		Make it possible for personnel with suspected laser-related injury to be examined and treated quickly by a medical professional.	Yes	Yes	Yes	Yes	Yes

Standards for Europe

Laser Classifications and Requirements

Europe (EN 60825-1)

* The following information was edited by OMRON based on the actual standard. OMRON assumes no responsibility for this information. You should always check the original text of the standard before implementing an actual application.

Requirement	Classification
	Class 1	Class 1M	Class 2	Class 2M	Class 3R	Class 3B	Class 4
Description of hazard class	Safe under reasonably foreseeable conditions.	As for Class 1 except may be hazardous if user employs optics.	Low power; eye protec- tion normally afforded by aversion responses.	As for Class 2 except may be hazardous if user employs optics.	Direct intrabeam viewing may be hazardous.	Direct intrabeam viewing normally hazardous.	High power; diffuse reflections may be hazardous.
Protective housing	Required for build-in laser products.	Required for each laser product; limits access except when necessary for performance of functions of the products.
Access panel safety interlock	Designed to prevent removal of the panel until accessible emission values are below that for Class 3R.				Designed to prevent removal of the panel until accessible emission values are below that for Class 3B or 3R.
Remote interlock connector	Not required.					Permits easy addition of external interlock in laser installation.
Manual reset	Not required.						Manual reset is required when power is interrupted or a remote interlock is activated.
Key control	Not required.					Laser inoperative when key is removed.
Laser emission warning	Not required.				Gives audible or visible warning when laser is switched on or if capacitor bank of pulsed laser is being charged. For Class 3R only, applies if invisible radiation is emitted.
Beam stop or attenuator	Not required.					Gives means to temporarily block beam.
Controls	Not required.				Controls so located that there is no danger of exposure to accessible emission limit above Class 1 or 2 when adjustments are made or operation is performed.
Viewing optics	Not required.		Emissions from all observation system must be below the accessible emission limits of Class 1M.
Scanning safeguard	Lasers must not exceed their assigned laser class even if scan failures occur.
Class label	Required wording.		Figures A and B and required wording.
Aperture label	Not required.				Specified wording required.
Service entry label	Not required.	Required as appropriate to the class of accessible radiation.
Labels for safety interlocked panels	Required under certain conditions as appropriate to the class of laser used.
Warning for visible and invisible laser radiation	Required for certain wavelength ranges.
Information for the user	Operation manuals must contain instructions for safe use. Additional requirements apply for Class 1M and Class 2M.
Purchasing and servicing information	Promotion brochures must specify product classification; service manuals must contain safety information.

Note:
1. The above table is a summarization of the basic requirements. You should always check the original text of the standard to understand and apply the actual standards.
2. Laser equipment used for healthcare applications are subject to IEC 60601-2-22.
3. Refer to IEC TR 60825-14 for a user's guide for laser products.

Standards for the USA

Laser Manufacturer Requirements

Conformance Guide for FDA Laser Products (April 2013)

(If you file with the FDA based on Laser Notice No.50, implement measures according to the IEC standards (same as the EN standards) and not according to the standards in this table.)

* The following information was edited by OMRON based on the actual standard. OMRON assumes no responsibility for this information. You should always check the original text of the standard before implementing an actual application.

Requirement	*Laser Class 1**
Requirement	Class I	Class IIa	Class II	Class IIIa	Class IIIb	Class IV
Capability (all laser products)
Protective housing	Required. *2	Required. *2	Required. *2	Required. *2	Required. *2	Required. *2
Safety interlocks	Required. 3 4	Required. 3 4	Required. 3 4	Required. 3 4	Required. 3 4	Required. 3 4
Location of controls	Exception	Required.	Required.		Required.	Required.
Limits on optics for observation	Required.	Required.	Required.	Required.	Required.	Required.
Scanning safeguard	Required.	Required.	Required.	Required.	Required.	Required.
Operation and performance (laser system)
Remote interlock connector	Exception	Exception	Exception	Exception	Required.	Required.
Key control	Exception	Exception	Exception	Exception	Required.	Required.
Laser radiation emission indicator	Exception	Exception	Required.	Required.	Required. *10	Required. *10
Beam attenuator	Exception	Exception	Required.	Required.	Required.	Required.
Manual reset mechanism	Exception	Exception	Exception	Exception	Exception	Required. *13
Operation and performance (products for a specific purpose)
Medical laser products	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class *8.	Same requirements as other products in same class *8.	Same requirements as other products in same class *8.
Surveying, leveling, and alignment laser products	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class.	Prohibited.	Prohibited.
Demonstration laser products	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class.	Same requirements as other products in same class *11.	Same requirements as other products in same class *11.
Labelling (all laser products)
Tests for determination of compliance	Required.	Required.	Required.	Required.	Required.	Required.
Protective housing	Depends on the internal radiation level *5.	Required. *5	Required. *5	Required. *5	Required. *5	Required. *5
Aperture	Exception	Exception	Required.	Required.	Required.	Required.
Class warning	Exception	Required. *6	Required. *7	Required. *9	Required. *12	Required. *12
Information (all laser products)
Information for the user	Required.	Required.	Required.	Required.	Required.	Required.
Product documentation	Exception	Required.	Required.	Required.	Required.	Required.
Servicing information	Required.	Required.	Required.	Required.	Required.	Required.

*1. Depends on the maximum possible exposure level during operation.
*2. Required for human exposure to laser radiation exceeding Class I other than radiation required for product functions.
*3. Required of a protective structure that can be opened during operation or maintenance when human exposure is never necessary while the structure is open.
*4. Interlock requirements depend on the internal emission class.
*5. The warning text depends on the laser emission level within the structure and on the wavelengths.
*6. Label with warning text.
*7. Logotype for CAUTION.
*8. An instrument to measure the laser emission level for intentional human radiation.
*9. "CAUTION" for 2.5 mW/cm² and "DANGER" for over 2.5 mW/cm².
*10. A time delay is required between emission display and emission.
*11. Variance (21 CFR 1010.4) approval is required for demonstration lasers or light shows for Class IIIb or IV.
*12. DANGER logotype.
*13. Required from August 20, 1986.

Main Laser Product Classifications

JIS/IEC/EN	FDA	Product name	Model
Class category	Class category	Product name	Model
Class 1	Class 1 (Laser Notice No.50)	Laser-type Smart Sensors	ZX2-LD50V
	Class II		ZX-LT001/030
	Class II		ZX-LT005/010
	Class 1 (Laser Notice No.50)	CMOS Laser Sensors with Built-in Digital Amplifiers	ZX0-LD50A[]L/LD100A[]L/ LD300A[]L/LD600A[]L
	Class 1 (Laser Notice No.50)	CMOS Laser Displacement Sensors with Built-in Digital Amplifiers	ZX1-LD50A[]L/LD100A[]L/ LD300A[]L/LD600A[]L
	Class II	Photoelectric Sensors with Separate Digital Amplifiers (Laser-type Amplifier Units)	E3C-LR12
	Class 1 (Laser Notice No.50)	Photoelectric Sensors with Built-in Amplifiers (Laser-type Amplifier Units)	E3Z-LR
			E3Z-LT
			E3Z-LL
	Class II	Smart Laser CCD Micrometer Sensors	ZX-GT[][]S
	Class 1 (Laser Notice No.50)	CMOS-type Smart Laser Heads	E3NC-SH100/250
		Smart Laser Heads	E3NC-LH01
			E3NC-LH02
			E3NC-LH03
	Class I	Safety Laser Scanners	OS32C
Class 2	Class II	Laser-type Smart Sensors	ZS-HLDS[]
	Class II	Smart Sensors (2D CMOS Laser Type)	ZS-LD[][]
	Class 2 (Laser Notice No.50)	Laser-type Smart Sensors	ZX2-LD[]/ZX2-LD[]L
	Class II	Laser-type Smart Sensors	ZX-LD[]
	Class 2 (Laser Notice No.50)	CMOS Laser Sensors with Built-in Digital Amplifiers	ZX0-LD50A[]/LD100A[]/ LD300A[]/LD600A[]
	Class 2 (Laser Notice No.50)	CMOS Laser Displacement Sensors with Built-in Digital Amplifiers	ZX1-LD50A[]/LD100A[]/ LD300A[]/LD600A[]
	Class II	Photoelectric Sensors with Separate Digital Amplifiers (Laser-type Amplifier Units)	E3C-LD11/21/31
	Class II		E3C-LR11
	Class 2 (Laser Notice No.50)	CMOS-type Smart Laser Heads	E3NC-SH250H
	Class 2 (Laser Notice No.50)	Laser-type Installed Bar Code Readers	V500-R521[][]
	Class 2 (Laser Notice No.50)	Laser-type Bar Code Readers	V500-R2[][]
	No application filed.	Laser Micrometers	3Z4L-S5[][]RV3
	Class II	Smart 2D Profile Measurement Sensors	ZG2-WDS3V
	Class II	Laser Pointers	F39-PTJ/PTR
Class 2M	Class IIIb	Smart 2D Profile Measurement Sensors	ZG2-WDS70/WDS22/WDS8
Class 3B	No application filed.	UV-Light Curing Systems (Head Unit)	ZUV-H20MC/H30MC/H10MC/H25MC/H35MC
Class 4	Class 4 (Laser Notice No. 50)	Fiber Laser Markers*	MX-Z2000G Series

Note: For details, refer to your OMRON website.
* Lasers for processing are Class 4. Guide lasers are Class 2.

Precautions for Safe Use of Laser Beams

(1) Ensure that the laser beam does not enter the eye either directly or by reflection off a mirror surface.
(When using a Class 4 laser, avoid eye or skin exposure to direct or scattered laser beams.)

(2) Labels of the type shown below are attached to Sensors that use lasers. (These are typical examples.) Observe the instructions given on the labels when handling the Sensors.

Class 1 Labels	Class 2 Labels

Class 3B Labels	Class 4 Labels

(3) Adjust the optical axis with an IR scope or a fluorescent plate that converts infrared rays into visible light.
(This does not apply to laser markers.)

(4) When exporting products to the EU or USA, attach the following labels, which are packed with the products. US FDA labels are included only with products that have been filed and registered with the FDA. (This does not apply to laser markers.)

Europe (EN Standard)

USA (FDA)

Cautions