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Irritation and sensitization testing of your medical devices according to ISO 10993-10
You want to perform irritation and sensitization testing of your medical devices according to ISO 10993-10
Irritation and sensitization testing according to ISO 10993-10 aims to assess the potential of medical devices and their constituent materials to cause skin irritation and sensitization.
With the support of a partner laboratory, FILAB assists you in performing irritation and sensitization tests on your medical devices in accordance with the ISO 10993-10 standard
In France, FILAB is one of the only laboratories in the medical device sector to offer you a complete analytical facility of 2100 m² for physico-chemical analyses as part of the biological evaluation of your medical devices.
FILAB offers you a comprehensive range of the following services:
Our services
Skin irritation and sensitization test according to ISO 10993-10
Chemical characterization according to ISO 10993-18
Degradation study according to ISO 10993-13 / -14 / -15
Cytotoxicity test according to ISO 10993-5
Toxicological evaluation of leachable substances according to ISO 10993-17
Etude physique, morphologique et topographique selon l'ISO 10993-19
But also for…
R&D support: custom chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Problem solving: non-conformity, breakage, adhesion, corrosion...
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee to our customers a reliability of the results, a fast treatment of the requests and a tailor-made support of their needs.
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²
Tailor-made support
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