Medlab medizinische Diagnosegeräte GmbH EG01010 User Manual
Version 1.06
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Regulatory Considerations
The device that has been described in this document is not a final medical product. That means that it
cannot be used as a standalone unit for patient use.
Therefore, the EG01010 has not been - and also cannot be - CE-marked. The customer has to undertake
the procedure of CE-marking the final product that contains the module. However, several products on
the market have successfully passed this certification using this OEM module.
The module complies with the following standards, as far as applicable:
IEC60601-1
EN 60601-1:2006+Cor.:2010+A1:2013
EN 60601-1-2:2015
EN 60601-2-27:2014
ANSI/AAMI EC13:2002
ANSI/AAMI EC57:1998
ANSI/AAMI EC57:2012
During testing and certification of a product, also the user manual of the final product needs to be
certified. The user manual has to contain certain technical data and warnings to the end users. We can
support customers by supplying material for the manual that has been used during the certification
process of Medlab's devices.
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