2 ISO 8655: 2002 parts 1-7A new international standard for piston operated volumetric apparatus which addresses the needs of:Supplier’s quality control and issuance of supplier’s declarations (QC-certificates)Test houses and after sales servicesTest equipment
3 Used standardsPreviously there were many national standards for pipettes:BS 7532: 1991; British standard year 1991ASTM E (Reapproved 1997), US- standardNCCLS; National Committee for Clinical Laboratory Standards, Proposed guidelineDIN 12650,1-6:1997; German standard which has 6 parts describing the type testing of a volumetric instrumentBut there was no universal international standard!
4 ISO 8655:2002, parts 1-7Terminology, general requirements and user requirementsPiston pipettesPiston burettesDilutorsDispensersGravimetric testingPhotometric testing (new 2006)
6 ISO 8655:2002 Supplier’s Liability ISO 8655 defines among other things supplier’s liabilitySuppliers should:Provide list of the contents of the apparatus packageProvide information on sterilizationProvide instruction for care, cleaning and maintenanceProvide information on temperature range in which the apparatus can be usedProvide information on chemical resistanceProvide instructions for re-calibrationProvide delivery(Ex) conditions’In addition, there are:Requirements for marking products (both tips and pipettes)Requirements for the features of pipettes and tips
7 ISO 8655:2002 User’s liability: The user should establish a regular testing routine for their pipettes with regard toaccuracy requirements of the applicationfrequency of usenumber of operations using the pipettenature of the liquid dispensedacceptable maximum permissible errors established by userUser should verify that the pipette is resistant to the liquid dispensed. This can be done by requesting information on chemical resistance from manufacturer or by conducting tests
8 ISO 8655:2002 Requirements for Calibration Requirements for test equipment (test apparatus)Requirements for test liquidRequirements for test conditionsRequirements for test procedure (directly and indirectly):Volumes to be testedNumber of measurements,Weighting procedureEvaluation: how to calculate and analyze the resultsRequirements for a calibration reportErrors affecting the performance of the pipetteTerms and definitions regarding piston operated pipettes and their testing
9 ISO 8655:2002Very important:ISO 8655 states that the given supplier’s declaration or the certificate of conformity is valid to the COMPLETE unit, which includes the pipette and tip used, as a combination.Please note:Type specs of a pipette manufacturer are valid only when the original manufacturers tips are usedWhen other than original tips are used, then the performance level of the NEW combination must be evaluated
10 ISO 8655:2002Every pipette distributor and pipette service company must be familiar with ISO 8655:2002 standardThe standard can be ordered fromor from your local standards association