The standard ISO 10993-1:2009 “Biological evaluation of medical devices – Part 1: Evaluation and testing” describes the strategy for the biological safety evaluation of a medical device with direct or indirect body contact. However, according to this standard first the suitability of a material regarding the physical and chemical characteristics should be evaluated: „In the selection of materials to be used in device manufacture, the first consideration shall be fitness for purpose with regard to characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. […] Identification of material chemical constituents and consideration of chemical characterization (see ISO 10993-18) shall precede any biological testing […]”.
For the material characterization of medical devices ISO 10993-18:2005 “Biological evaluation of medical devices – Part 18: Chemical characterization of materials” was issued as a guideline. The material characterization supports the manufacturer at an early stage to evaluate the critical material properties or leachable chemical substances. Furthermore, during the development of new products an identification and quantification of possible degradation products has to be performed in accordance with ISO 10993-9, ISO 10993-13 (polymers), ISO 10993-14 (ceramics) and ISO 10993-15 (metals and alloys). All identified leachable and degradation products should be subjected to a toxicological evaluation in order to estimate its toxicological risk during application of the device under evaluation.
After launching a device, accompanying inspections are necessary. This may include inspections of raw materials, in-process controls, final inspections of the product (e. g., residual monomer content, “fingerprint” of extractable substances, sterilization residues) as well as tests of packaging materials.
UL MDT uses numerous modern analytical test procedures, like GC/MS, HPLC, FTIR, ICP, XPS and SEM/EDX to help you perform the required physicochemical analyses.
What we offer:
- Material Characterization of Medical Devices
- Physicochemical Analyses of Polymeric Materials
- Metal and Ceramic Analyses
- Residue Analyses
- Toxicological Evaluation of Leachables and Degradation Products