Advertisement
● FDA (Compliance Guide for Laser Products, 1985, according to 21 CFR1040.10)
Requirements
Performance (all laser products)
Protective housing
R
(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
N/A
Viewing optics
R
Scanning safeguard
R
Performance (laser systems)
Remote control connector N/A
Key control
N/A
Emission indicator
N/A
Beam attenuator
N/A
Reset
N/A
Performance (specific purpose products)
Medical
S
Surveying, leveling, align-
S
ment
Demonstration
S
Labeling (all laser products)
Certification & identifica-
R
tion
Protective housing
D
(see note 5)
Aperture
N/A
Class warning
N/A
Information (all laser products)
User information
R
Product literature
N/A
Service information
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 radia-
tion 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 nec-
essary when housing is open.
4. Interlock requirements vary according to Class of internal radi-
ation.
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 cm
–2
2.5 mW cm
.
10.Delay required between indication & emission.
I
IIa
R
(see note 2)
R
R
R
N/A
N/A
N/A
N/A
N/A
S
S
S
R
D
(see note 5)
N/A
R
(see note 6)
R
R
R
2
or less, DANGER if greater than
Class (see note 1)
II
IIIa
R
R
(see note 2)
(see note 2)
R
R
R
R
R
N/A
N/A
N/A
N/A
R
R
R
R
N/A
N/A
S
S
(see note 8)
S
S
S
S
R
R
D
D
(see note 5)
(see note 5)
R
R
R
R
(see note 7)
(see note 9)
R
R
R
R
R
R
11.Variance required for Class IIb or iV demonstration laser prod-
ucts and light shows.
12.DANGER logotype.
13.Required after August 20, 1986.
ZX Series (ZX-L)
IIIb
IV
R
R
(see note 2)
(see note 2)
R
R
R
R
R
R
R
R
R
R
R
R
(see note 10)
(see note 10)
R
R
N/A
R
(see note 13)
S
S
(see note 8)
(see note 8)
NP
NP
S
S
(see note 11)
(see note 11)
R
R
D
D
(see note 5)
(see note 5)
R
R
R
R
(see note 12)
(see note 12)
R
R
R
R
R
R
Smart Sensors
17
Advertisement
