Liquid silicone rubbers of the SILPURAN 6600 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.Compared to the SILPURAN 6000 series the coefficient of friction of a post-cured article made of SILPURAN 6600 is reduces by 50-70%. SILPURAN 6600/50 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
• Less self-healing
• Low coefficient of friction
• Reduced volatile content
Applications
• Medical Devices
Application details
The following studies were performed on vulcanizates of SILPURAN 6600/50 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 6600/50 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 upon request. Properly cured and post-cured vulcanizates of SILPURAN 6600/50 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.
First level agent
Glory Hill International Enterprise Limited
Telephone:+852 6037 6803
E-mail:hillman@glory-hill.com