Maintenance of Major System Units/Laser Scanning Microscope
V .
MAINTENANCE
V.
2-3
Page
The definitions of the term “maintenance” by EN60825 and CDRH 21CFR are quoted
below for reference.
IEC60825(EN60825)
Maintenance:
The performance of those adjustments or procedures specified in user information
provided by the manufacturer with the laser product, which are to be performed by the
user for the purpose of assuring the intended performance of the product. It does not
include operation or service.
The definitions of the term “maintenance” are quoted below for reference.
CDRH
“Maintenance” means performance of those adjustments or procedures specified in user
information provided by the manufacturer with the laser product which are to be
performed by the user for the purpose of assuring the intended performance of the
product. It does not include operation or service as defined in paragraph (b) (27) and
(38) of this section.
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