Your needs: studying the degradation products of your polymer medical devices according to ISO 10993-13
What is ISO 10993-13?
ISO 10993-13 is part of the standards in the NF EN ISO 10993 series, established to assess the biocompatibility of medical devices. It specifically concerns the identification and quantification of degradation products from polymer materials that may migrate into the body when in contact with the device.
These biocompatibility tests assess the degradation of polymer materials and verify their ability to perform a given function without causing adverse effects.
ISO 10993-13 defines the applicable regulations for the identification and quantification of degradation products from medical devices composed of polymers. The degradation products analysed under ISO 10993-13 may result from chemical alteration.
Why perform an ISO 10993-13 analysis?
The purpose of analysing your medical devices according to ISO 10993-13 is to:
ISO 10993-13 analysis
Ensure patient safety by identifying and quantifying substances that may be released by a medical device during use
Ensure that medical devices comply with ISO 10993-13 and obtain marketing authorisation
Improve medical device design by selecting safer, higher-performance materials
Are you looking for a reliable, responsive laboratory to support you with the analysis of your medical devices according to ISO 10993-13?
Our solutions: supporting you with biocompatibility analysis according to ISO 10993-13
Why choose FILAB for an ISO 10993-13 analysis?
For more than ten years, FILAB laboratory has developed extensive expertise in chemical analysis and materials characterisation. FILAB laboratory has a state-of-the-art analytical facility spanning more than 5,200 m2 as well as highly qualified staff, enabling it to offer medical device manufacturers services that meet their compliance requirements under ISO 10993-13 for the identification and quantification of degradation products.
Whatever your biomaterial, rely on an expert laboratory for the chemical characterisation of your materials and the biocompatibility assessment of your medical devices:
Our expertise
Identification and quantification of degradation products from polymer-based medical devices according to ISO 10993-13 and ISO 10993-14
FILAB also supports you with the following services:
Our services
Biocompatibility studies according to ISO 10993
Problem-solving through failure analysis: non-conformity, breakage, adhesion, corrosion...
R&D support: tailor-made chemical analysis, materials and surface characterisation, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Our human scale, ongoing investments, and knowledge of the medical device sector guarantee our clients reliable results, rapid processing of requests, and tailored support for their ISO 10993-13 analysis needs.
