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Section9
Requirements from Regulations and Standards
■ For U.S.A
FDA (Compliance Guide for Laser Products, 1985, according to 21 CFR1040.10)
Requirements
Performance (all laser products)
Protective
housing
Safety interlock
Location of
controls
Viewing optics
Scanning
safeguard
Performance (laser systems)
Remote control
connector
Key control
Emission
indicator
Beam attenuator
Reset
Performance (specific purpose products)
Medical
Surveying, level-
ing, alignment
Demonstration
Labeling (all laser products)
Certification &
identification
Protective
housing
Aperture
Class warning
Information (all laser products)
User information
Product literature N/A
Service
information
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.
ZS-HL
9-8
User's Manual
I
IIa
R (see note 2) R (see note 2) R (see note 2) R (see note 2) R (see note 2) R (see note 2)
R
R
(see notes 3,4)
(see notes 3,4)
N/A
R
R
R
R
R
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
S
S
S
S
S
S
R
R
D (see note 5) D (see note 5) D (see note 5) D (see note 5) D (see note 5) D (see note 5)
N/A
N/A
N/A
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
Class (see note 1)
II
IIIa
R
R
(see notes 3,4)
(see notes 3,4)
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 (see note 8) S (see note 8)
S
S
S
S
R
R
R
R
R
R
R
R
R
R
IIIb
IV
R
R
(see notes 3,4)
(see notes 3,4)
R
R
R
R
R
R
R
R
R
R
R (see note 10) R (see note 10)
R
R
N/A
R (see note 13)
NP
NP
S (see note 11) (see note 11)
R
R
R
R
R
R
R
R
R
R
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