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PANNORAMIC® CONFOCAL RX 1.0
DECLARATION OF CONFORMITY
MAY 13, 2021
6
FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES .
Declaration of Conformity
3DHISTECH Ltd. declares that the product Pannoramic® Confocal RX is designed and produced
with consideration of the quality management system certified according to the ISO 13485:2016
standard, and conforms to standards listed below:
IEC 61010-
1:2010 (ed. 3), “Safety requirements for electrical equipment for measurement, control,
and laboratory use
–
Part 1: General requirements”
EN 61326-
1:2013 “Electrical equipment for measurement, control and laboratory use –
EMC
requirements
–
Part 1:
General requirements”
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and
laboratory use
–
Part 1: General requirements
EN 61326-1:2013
EN 55011:2009+A1:2010
EN 61000-3-2:2006+A1:2009+A2:2009
EN 61000-3-3:2013
Further information may be obtained from the manufacturer:
3DHISTECH Ltd.
3 Öv Street, 1141 Budapest
–
HUNGARY