Do you use silicone in the medical devices you produce? If so, you need to be aware that the European Chemicals Agency (ECHA) can now classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT), Very Persistent and Very Bioaccumulative substances (vPvB), and suspected to be toxic to human reproduction after a decisive ruling by the European Court of Justice.
Silicone oligomers are an unavoidable result of the production processes for silicone that must now be accounted for before a medical device containing silicone can be approved for sale in the EU.
At SAXOCON, we have the expertise to properly risk assess the silicone in your products to determine if it meets the new requirements. This ruling marks a change that has far-reaching consequences for new and existing products. Contact us to find out how we can help you determine how compliant your silicone products are.
We have several services to help risk assess your products, including:
Materials screening and selection
Surface characterisation
Device-drug safety