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k990400 September 19, 2007
Calibration and Quality Assurance
10-25
meets or exceeds all Imaging Sciences International published specifications. The
test equipment used to test and calibrate the equipment listed above is regularly
calibrated against company standards that are directly traceable to National Institute
of Standards Technology. The equipment has also been tested and/or evaluated
against and found compliant to the following standards/requirements:
UL 60601-1 IEC/EN 60601-1-4
CSA C22.2 No. 601.1 IEC/EN 60601-2-32
JIS Z4701 IEC/EN 60601-2-44
JIS Z4703 IEC/EN 60825-1
JIS T0601 CE-MDD 93/42/EEC
IEC/EN 60601-1 LVFS 2003:11 (Swedish regulation, transposing the MDD 93/42/EEC)
IEC/EN 60601-1-1 CMDCAS (Canadian Medical Device Regulation)
IEC/EN 60601-1-2 ISO 10993-1:2003
IEC/EN 60601-1-3 ISO 14971:2000
The Quality System of Imaging Sciences International has been
assessed and registered to ISO 13485:2003 and ISO 9001:2000. The
Quality System of Imaging Sciences International also complies
with applicable requirements of the European Union Council
Directive concerning Medical Devices 93/42/EEC, LVFS 2003:11,
Food and Drug Administration (FDA), applicable sections of
21CFR parts 800 to 1050 and Canadian Medical Devices
Regulations (CMDR), relevant sections 2 to 65 for medical devices.
Mario P. Infanti
Director of Regulatory Affairs and Quality Assurance