Declaration Of Conformity - 3D Histech Pannoramic 250 FLASH II User Manual

Pannoramic 250 FLASH II 1.18.1 User's Guide

Declaration of Conformity

3DHISTECH Ltd. declares that the product Pannoramic 250 FLASH II slide scanner is designed and
produced with consideration of specified requirements according to the ISO 13485:2003 and IEC
61326-2-6:2005 standards, and conforms to the directives and other standards listed below:
IEC 61010-1:2001 (ed. 2), "Safety requirements for electrical equipment for measurement, control,
and laboratory use – Part 1: General requirements"
IEC 61010-2-101:2002 (ed. 1), "Safety requirements for electrical equipment for measurement,
control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment"
EN 55011:1998, Group 1, Class A, "Limits and methods of measurement of radio disturbance
characteristics of industrial, scientific, and medical (ISM) radio-frequency equipment"
This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1, second
edition, including Amendment 1, or a later version of the same standard incorporating the same level
of testing requirements.
Conformity with Directive 98/79/EC is marked by
Conformity with Directive IEC 61010-2-101:2002 (ed. 1) is marked by
labeling.
Further information may be obtained from the manufacturer:
3DHISTECH Ltd.
29-33 Konkoly-Thege Miklos street, Building 6
1121 Budapest – HUNGARY
May 29, 2014 – Rev. 1
on the Pannoramic 250 FLASH II device.
3DHISTECH Ltd.
Declaration of Conformity
on the product
8(137)