Material selection and risk analysis are integral components of the design process for medical devices. The international standards revision for the medical device biological evaluation within the risk assessment process (ISO 10993-1) states that the description of the chemical components of direct and indirect contact medical devices and the consideration of material characterization, including chemical characterization, must precede any biological test (ISO 10993-18).
Chemical characterization with an appropriate toxicological threshold may be used to determine whether further testing is required (ISO 10993-17 and ISO 10993-18). Based on the proposed revisions, chemical characterization of a medical device provides the necessary input into the device’s biological evaluation and toxicological risk assessment.
- Determine the chemical composition of the Medical Devices
- Extractables and leachables studies ISO 10993-17 and ISO 10993-18
The interaction between both primary and secondary containers and the drug may affect the composition of the latter, thus adversely impacting its ability to produce the expected clinical outcome, or its safeness. Extractables and Leachables studies provide a full integrated testing strategy together with toxicological assessment and risk analysis:
- profiling of extractables
- characterization of extractables
- research into organic compounds using TOC, HPLC-UV/DAD, HPLC-ELSD, LC-MS/MS, LC-Q/Orbitrap and GC-MS
- research into elemental impurities using AA, ICP-OES or ICP-MS
- development and validation of methods suitable for the quantification of specific leachables present in the drug matrix, based on the extractables studies
- Structural composition or configuration of the Medical Device material evaluation:
- Synthetic polymer ISO 10993-13
- Metals and alloys ISO 10993-15
- Ceramics ISO 10993-14
- Natural macromolecules
- ICP-OES / ICP-MS