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FDA (21 CFR1040.10 "Laser Products")
Requirements
I
Performance (all laser products)
Protective
R (see note 2) R (see note 2) R (see note 2) R (see note 2) R (see note 2) R (see note 2)
housing
R
Safety interlock
(see notes 3,4)
Location of
N/A
controls
Viewing optics
R
Scanning
R
safeguard
Performance (laser systems)
Remote control
N/A
connector
Key control
N/A
Emission
N/A
indicator
Beam attenuator
N/A
Reset
N/A
Performance (specific purpose products)
Medical
S
Surveying, level-
S
ing, alignment
Demonstration
S
Labeling (all laser products)
Certification &
R
identification
Protective
D (see note 5) D (see note 5) D (see note 5) D (see note 5) D (see note 5) D (see note 5)
housing
Aperture
N/A
Class warning
N/A
Information (all laser products)
User information
R
Product literature N/A
Service
R
information
Abbreviations:
R:
N/A:
S:
NP:
D:
Class (see note 1)
IIa
II
R
R
(see notes 3,4)
(see notes 3,4)
R
R
R
R
R
R
N/A
N/A
N/A
N/A
N/A
R
N/A
R
N/A
N/A
S
S
S
S
S
S
R
R
N/A
R
R (see note 6) R (see note 7) R (see note 9) R (see note 12) R (see note 12)
R
R
R
R
R
R
Required.
Not applicable.
Requirements: Same as for other products of that Class. Also see footnotes.
Not permitted.
Depends on level of interior radiation.
IIIa
IIIb
R
R
(see notes 3,4)
(see notes 3,4)
R
R
R
R
R
N/A
R
N/A
R
R
R (see note 10) R (see note 10)
R
R
N/A
N/A
S (see note 8) S (see note 8) S (see note 8)
S
NP
S
S (see note 11) (see note 11)
R
R
R
R
R
R
R
R
R
R
SECTION 4
Appendix
IV
R
(see notes 3,4)
R
R
R
R
R
R
R (see note 13)
NP
R
R
R
R
R
Z500
75
Setup Manual
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