|
Development
of standardised test methods for cytocompatibility |
|
considering
special demands on implants and medical products |
|
for the
medical device industry |
| Contract
number |
|
SMT4-CT95-2040 |
Proposal
number |
|
1520-PL-95-2087 |
| Start
date |
|
01-Feb-96 |
Duration |
|
2.5 years |
| RTD
programme |
|
Standards Measurement and
Testing |
| Coordinator |
|
Dr H-A Richter |
|
Organisation |
|
Aachen University of
Technology (RWTH Aachen) |
|
Department |
|
Department of Pathology |
| Country |
|
Germany |
Postcode |
|
D-52057 |
| Telephone |
|
49 241 8089288 |
Fax |
|
49 241 8888439 |
| Partner |
|
Vygon SA, Ecouen, FR |
| Partner |
|
Tecnobiomaterial srl,
Pisa, IT |
| Partner |
|
Hopital St Antione, Paris,
FR |
| Partner |
|
KreCo GmbH, Munich, DE |
| Partner |
|
BIOCOM SA, Les Ulis, FR |
| Additional
Partner |
|
Universita degli Studi di
Pisa, IT |
| Summary |
|
The objective of this
project is the development of a cytocompatibility |
|
test with semi-automatic
image analysis for polymers used for |
|
catheters and intraocular
lenses (IOL). |
|
1. the identification of
control materials which best represent the |
|
polymers used for the
production of catheters and intraocular lenses |
|
2. testing of
physico-chemical and cytocompatibility parameters for |
|
3. development, testing
and optimisation of in-vitro cytocompatability |
|
assessment procedures and
the elaboration of related standardised |
|
operation procedures (SOP)
taking into account the specific |
|
requirements for testing
in an industrial environment |
|
4. dissemination of
results in workshops, publications and in form of a |
|
recommendation to Comité Européen de Normalisation (CEN). |
| Achievements |
|
The aim has been reached.
The results of the SMT-Project CYTOTOX |
|
have been presented at the
workshop CYTOTOX in Aachen with about |
|
50 participants from
industry, research laboratories and from |
|
universities on 11
February 1998. The result is a manual with the title |
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