UM-1151140EN, Rev. C, May 2016
Laser
Safety
and
Regulatory
●
ISO 10993-1: Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing in the Risk Management
Process.
●
RoHS: Restriction of Hazardous Substances
DIRECTIVE 2011/65/EU.
●
REACH: Registration, Evaluation, Authorization and
Restriction of Chemicals.
●
WEEE
Waste Electrical and Electronic Equipment
Directive.
In compliance with these standards, the system is equipped with:
●
Laser emission indicators
●
Beam shutter
●
Power display
●
Laser emergency stop button
●
Door interlock connector
●
Proper labeling
In accordance with the regulations, a recommended routine inspection and
maintenance schedule is provided in the Maintenance chapter of this
manual.
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