Pannoramic 1000 1.2 – User’s Guide
Declaration Of Conformity
3DHISTECH Ltd. declares that the product Pannoramic 1000 digital slide scanner is designed and
produced with consideration of specified requirements according to the ISO13485 Medical devices.
Quality management systems. Requirements for regulatory purposes (ISO 13485:2016).
IEC 61010-1:2010 – “ Safety requirements for electrical equipment for measurement, control, and
laboratory use. General requirements ”
IEC 61010-2-081:2015 – “ Safety requirements for electrical equipment for measurement, control and
laboratory use. Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes ”
IEC 61010-2-101:2002, “ Safety Requirements for Electrical Equipment for Measurement, Control,
and Laboratory Use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment ”
IEC 55011:2016 – Group 1, Class B – “Industrial, scientific and medical (ISM) equipment – Radio-
frequency disturbance characteristics - Limits and methods of measurement ”
Conformity with Directive IEC 61010-2-101 is marked by on the product labeling.
There is no further operator (user) action required in case of residual risks.
Further information may be obtained from the manufacturer:
3DHISTECH Ltd.
3 Öv street
1141 Budapest – HUNGARY
March 19, 2019 – Rev. 2 3DHISTECH Ltd. 6(78)
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