11 Calibration Solutions for Osmometry
11 Calibration Solutions for Osmometry
11.1 GONOTEC Calibration and Reference Material
Classification of the IVD
The calibration and reference materials by Gonotec are non-invasive in-vitro diagnostic products
according to EEC Directive 93/42 (Medical Devices Law). They are intended for use in osmometry by
qualified personnel to calibrate and/or control the osmometer. The calibration and reference materials
must be used in accordance with the unit requirements.
The calibration and reference materials are not named in Annex II, List A or B, of the Directive 98/79
for in-vitro diagnostic devices. Compliance is declared per Annex III. Number 6 of Annex II is
disregarded, since the calibration and reference materials' intended use does not include personal use.
EC Conformity Declaration – Calibration and Reference Material
Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin / Germany
We hereby declare that the calibration standard for Osmomat 010/030/auto (300 and 850 mOsmol/kg
NaCl/H
2
O) and the reference solution OSMOREF
®
290 mOsmol/kg comply with Directive 98/79/EEC.
Compliance is declared per Annex III of the Directive. The CE mark on the standards and reference
solutions acknowledges this.
Date: 10/24/2009
Signature of managing director:
........................................
Provisions of Certification
CE compliance requires that the calibration standard and the reference solution be used in the manner
described in this manual and/or in the package insert. Any departure from the specifications or
independent modifications of the calibration standard or the reference solution without the express
consent of Gonotec GmbH may result in a violation of CE requirements. Such actions invalidate the
compliance statement and transfer responsibility to the originator of said actions.
Calibration Solutions for Osmometry
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