SILPURAN® silicone products are tested for biocompatibility and comply with all current standards relating to modern medical technology.
- SILPURAN® series products are biocompatible according to selected ISO 10993 and USP Class VI tests.
- SILPURAN® LSR/HTV grades comply with monograph 3.1.9 “Silicone elastomers for closures and tubing" of the European Pharmacopoeia in respect of tests for volatile matter and substances soluble in hexane.
- SILPURAN® LSR/HTV grades comply with the requirements of the BfR (German Institute for Risk Assessment, XV Silicones, Section III, Silicone Elastomers) and the FDA (CFR 21 § 177.2600 “Rubber articles intended for repeated use") and so are suitable for food contact.
- Please contact us regarding the FDA Master Files for Devices.