● FDA (Compliance Guide for Laser Products, 1985, according to 21 CFR1040.10)
Requirements
Class (see note 1)
II IIIa
I
IIa
IIIb
IV
Performance (all laser products)
Protective housing
R
R
R
R
R
R
(see note 2)
(see note 2)
(see note 2)
(see note 2)
(see note 2)
(see note 2)
Safety interlock
R (see notes 3, 4) R (see notes 3, 4) R (see notes 3, 4) R (see notes 3, 4) R (see notes 3, 4) R (see notes 3, 4)
Location of controls
Viewing optics
N/A
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
Scanning safeguard
R
Performance (laser systems)
Remote control connector N/A
N/A
N/A
N/A
N/A
N/A
R
N/A
N/A
R
R
R
R
R
Key control
N/A
N/A
Emission indicator
R
R
(see note 10)
(see note 10)
Beam attenuator
Reset
N/A
N/A
N/A
N/A
R
R
R
R
N/A
N/A
N/A
R
(see note 13)
Performance (specific purpose products)
Medical
S
S
S
S
S
S
S
S
S
S
S
S
(see note 8)
(see note 8)
(see note 8)
Surveying, leveling, align-
ment
S
NP
NP
Demonstration
S
S
S
(see note 11)
(see note 11)
Labeling (all laser products)
Certification & identifica-
tion
R
R
R
R
R
R
Protective housing
D
D
D
D
D
D
(see note 5)
(see note 5)
(see note 5)
(see note 5)
(see note 5)
(see note 5)
Aperture
N/A
N/A
N/A
R
R
R
R
Class warning
R
R
R
R
R
(see note 6)
(see note 7)
(see note 9)
(see note 12)
(see note 12)
Information (all laser products)
User information
Product literature
Service information
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
R
N/A
R
Abbreviations:
R: Required.
N/A: Not applicable.
S: Requirements: Same as for other products of that Class.
Also see footnotes.
NP: Not permitted.
D: Depends on level of interior radiation.
Footnotes:
1. Based on highest level accessible during operation.
2. Required wherever & whenever human access to laser radiation above Class I limits is not needed for product to perform its function.
3. Required for protective housings opened during operation or maintenance, if human access thus gained is not always necessary when
housing is open.
4. Interlock requirements vary according to Class of internal radiation.
5. Wording depends on level & wavelength of laser radiation within protective housing.
6. Warning statement label.
7. CAUTION logotype.
8. Requires means to measure level of laser radiation intended to irradiate the body.
9. CAUTION if 2.5 mW cm2 or less, DANGER if greater than 2.5 mW cm2.
10.Delay required between indication & emission.
11.Variance required for Class IIb or iV demonstration laser products and light shows.
12.DANGER logotype.
13.Required after August 20, 1986.
ZX Series (ZX-L-N) Smart Sensors (Laser Type)
19
OMRON [ OMRON ELECTRONICS LLC ]
