ISO-8655:2002

ISO 8655: 2002 parts 1-7

A 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 services– Test equipment

Used standards

Previously there were many national standards for pipettes: – BS 7532: 1991; British standard year 1991– ASTM E 1154-89 (Reapproved 1997), US- standard– NCCLS; National Committee for Clinical Laboratory

Standards, Proposed guideline– DIN 12650,1-6:1997; German standard which has 6

parts describing the type testing of a volumetric instrument

But there was no universal international standard!

ISO 8655:2002, parts 1-7

1. Terminology, general requirements and user requirements

2. Piston pipettes3. Piston burettes4. Dilutors5. Dispensers6. Gravimetric testing7. Photometric testing (new 2006)

How the ISO 8655:2002 affects

your work?

ISO 8655:2002 Supplier’s Liability

• ISO 8655 defines among other things supplier’s liability

• Suppliers should: – Provide list of the contents of the apparatus package– Provide information on sterilization– Provide instruction for care, cleaning and maintenance– Provide information on temperature range in which the

apparatus can be used– Provide information on chemical resistance– Provide instructions for re-calibration– Provide delivery(Ex) conditions’

• In addition, there are:– Requirements for marking products (both tips and pipettes)– Requirements for the features of pipettes and tips

ISO 8655:2002User’s liability:

• The user should establish a regular testing routine for their pipettes with regard to– accuracy requirements of the application– frequency of use– number of operations using the pipette– nature of the liquid dispensed– acceptable maximum permissible errors

established by user

• User 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

ISO 8655:2002 Requirements for Calibration

• Requirements for test equipment (test apparatus)• Requirements for test liquid• Requirements for test conditions• Requirements for test procedure (directly and

indirectly): – Volumes to be tested – Number of measurements, – Weighting procedure

• Evaluation: how to calculate and analyze the results

• Requirements for a calibration report• Errors affecting the performance of the pipette• Terms and definitions regarding piston operated

pipettes and their testing

ISO 8655:2002

Very 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 used

•When other than original tips are used, then the performance level of the NEW combination must be evaluated

ISO 8655:2002

• Every pipette distributor and pipette service company must be familiar with ISO 8655:2002 standard

• The standard can be ordered from www.iso.ch or from your local standards association