CYCLERtest Thermocycler Calibration
Accreditation norms require thermocycler calibration to be carried out independent of the instrument manufacturer and supplier, to be traceable, tamperproof and performed on site.
The P-Squared thermocycler calibration system, developed by CYCLERtest, has been calibrated against the NIST standard and is verified by the Dutch Council for Accreditation according to the ISO 17025 standard, traceable according to ITS-90.
P-Squared Technologies delivers service independent of any thermocycler manufacturer and supplier and is carried out on-site and in situ.
Calibration test results are analyzed and reported through an automated process, prohibiting any alterations of the acquired sample data, to be tamperproof.
CYCLERtest and P-Squared’s policy is that only personnel, trained and certified at the CYCLERtest facilities in the Netherlands, perform calibration measurements. Full documentation together with calibration certificate and report is supplied for each completed calibration.
- Calibration certificates for each PCR cycler as performed by P-Squared Technologies.
- A detailed outline of the measurement procedure used to calibrate each of the cyclers.
- A valid training certificate of the calibration engineer that performed the measurements to certify competence in the Mtas calibration system and analysis by CYCLERtest. CYCLERtest on site thermocycler calibration service is ISO 17025 accredited (RvA K145) and thereby meets all international requirements of a manufacturer independent traceable calibration as demanded by the accreditation standards of ISO 17025 accredited testing labs, ISO 15189 accredited medical testing labs and ISO 13485 certified CE-IVD kit manufacturers.
- Valid calibration certificates from CelsiusLabs for each probe set used to perform the annual calibration. The calibration equipment has been calibrated traceable to the international temperature standard ITS-90 by CelsiusLabs which is an ISO17025 accredited calibration laboratory (RvA K145). Please refer to the equipment information on the last page of each cycler calibration certificate for detail on the probe set used for each instrument.
- A calibration sticker from CYCLERtest indicating the date of calibration, the certificate number associated with the instrument as well as the company that performed the calibration (P-Squared technologies). This sticker should be placed on each instrument as a record of calibration. We recommend that instruments are calibrated annually at the same time each year to maintain consistency.
- Measurement uncertainty: Please refer to page 2 of each calibration certificate for details on how the measurement uncertainty is calculated for each calibration.
- Environmental conditions: Please refer to page 3 of each calibration certificate to see the report of the ambient temperature and humidity of the environment where the cycler is placed as recorded during the calibration measurement. The environmental conditions should fall within the parameters specified to comply with the set standards.
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