Certificate of conformity and system validation – Metrohm 754 Dialysis Unit User Manual
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5 Appendix
754 Dialysis Unit
42
5.4.3 Certificate of conformity and system validation
Certificate of Conformity and System Validation
This is to certify the conformity to the standard specifications for electrical appli-
ances and accessories, as well as to the standard specifications for security and
to system validation issued by the manufacturing company.
Name of commodity:
754 Dialysis Unit
Name of manufacturer:
Metrohm Ltd., Herisau, Switzerland
Principal technical information:
Voltages:
100…120, 220…240 V
Frequency:
50
…
60 Hz
This Metrohm instrument has been built and has undergone final type testing
according to the standards:
IEC801-2/IEC1000-4-2 (class 4), IEC801-3/IEC1000-4-3 (class 3),
IEC801-4/IEC1000-4-4 (class 4), IEC801-6/IEC1000-4-6 (class 3),
IEC1000-4-11, EN55011 (class B), EN55022 (class B), EN50081-1,
EN50082-2, EN60555-2
— Electromagnetic compatibility
IEC1010, EN61010, UL3101-1
— Security specifications
The technical specifications are documented in the instruction manual.
Metrohm Ltd. is holder of the SQS-certificate of the quality system ISO 9001 for
quality assurance in design/development, production, installation and servicing.
Herisau, September 27, 1997
Dr. J. Frank
Ch. Buchmann
Development Manager
Production and
Quality Assurance Manager