Chemical characterization of medical device materials within a risk management process.
In order to test the biocompatibility of medical devices, qualitative and quantitative data must be collected on the materials that make up the items in the context of biological safety. The medical device should be tested using appropriate techniques to collect data on its composition and its potential extractibles & leachables.
The ISO 10993-18 studies should be performed when developing a new medical device, when changing the manufacturing process or when changing raw materials and/or suppliers.
Chemical characterization alone can be insufficient to establish the equivalence or biocompatibility of materials and medical devices, and cannot unilaterally substitute for biological testing. However, chemical characterization in combination with risk assessment can be a necessary part of judging chemical equivalence and assessing biocompatibility, and if appropriately conducted can be used in lieu of certain biological tests.
Extractables & Leachables Studies
- Headspace Gas Chromatography (Headspace GC-MS) for Volatile Organic Compound (VOC) analysis
- Gas Chromatography (GC-MS) for Semi-Volatile Organic Compounds (SVOC) analysis
- Liquid Chromatography (LC-MS) for Non-Volatile Organic Compounds (NVOC) analysis
- Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) for elemental analysis
ISO 10993-18, but also…
- ISO 10993-22 : Guidelines on nanomaterials
- Customized chemical analysis
- Problem solving (method validation, etc.)
- Literature screening