ISO-8655:2002

ISO 8655: 2002 parts 1-7

A new international standard for piston
operated volumetric apparatus which
addresses the needs of:
Suppliers quality control and issuance of
suppliers 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 pipettes
3. Piston burettes
4. Dilutors
5. Dispensers
6. Gravimetric testing
7. Photometric testing (new 2006)





How the ISO 8655:2002
affects your work?



ISO 8655:2002
Suppliers Liability
ISO 8655 defines among other things suppliers 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 8655:2002
Users 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 suppliers
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