Compliance - Leica TCS SP8 STED 3X User Manual

23.3

Compliance

This system has been tested and meets the requirements of the following standards:
IEC/EN 61010-1:2011
IEC/EN 60825-1:2007
IEC/EN 61326-1:2006
For use in the USA:
CDRH 21 CFR 1040.10:
For the USA (area of validity of the CDRH/FDA), the designations of the laser class are to be
changed in the text from 3B to IIIb and Class 4 to IV.
"Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 1: General requirements"
"Safety of laser products - Part 1: Equipment classifications and
requirements"
"Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 1: General requirements (class A)"
This is a Class A instrument for use in buildings that do not include
domestic premises and buildings not directly connected to a low-
voltage power supply network that supplies buildings used for
domestic purposes.
Laser Products U.S. Food and Drug Administration (FDA) "Complies
with FDA performance standards for laser products except for
deviations pursuant to laser notice No. 50, dated June 24, 2007".
Appendix
113