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

Thank you !

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