Liquid silicone rubbers of the SILPURAN LR 6000 series are paste-like, easily-pigmentable two- component compounds with short curing times. Their vulcanizates are noted for their high transparency and excellent mechanical and electrical properties. SILPURAN LR 6000/50 A/B is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including imolantation for ＜30 days. 

Specific features

• Food-contact 

• Reduced volatile content

Applications 

• Medical Devices

Application details

The following studies were performed on vulcanizates of SILPURAN 6000/50 A/B according to ISO 10993: 

-Cytotoxicity (ISO 10993-5)

-Sensitation LLNA (ISO 10993-10)

-Pyrogenicity (ISO 10993-11)

The following studies were performed on vulcanizates of SILPURAN 6000/50 A/B according to USP class VI: 

-Acute systemic toxicity

-Intracutaneous toxicity

-Implantation test

No adverse effects have been detected at any of the studies performed. A master file has been filed with the U.S. Food and Drug Administration. An authorization to reference the master file will be available upom request. Properly cured and post-cured vulcanizates of SILPURAN 6000/50 A/B can be used for food contact applications and are suitable for use under the Recommendation"XV.Sillcones"of the BfR and FDA 21 CFR § 177.2600"Rubber Articles Intended for Repeated Use"considering any given limitations on extractable and volatile substances.