Liquid silicone rubbers of the SILPURAN 6610 series are paste-like,two-component compounds. Their vulcanizates are noted for their significantly reduced tendency towards a radical induced reattachment,i.e.healing,of slit valve surfaces during sterilization by gamma irradiation and ebeam(≤75kGy). SILPURAN 6610/50 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

• Reduced volatile content

Applications 

• Medical Devices

Application details

The following studies were performed on vulcanizates of SILPURAN 6610/50 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 6610/50 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. Properly cured and post-cured vulcanizates of SILPURAN 6610/50 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.Solely contact with acidic foodstuff is not recommended as this might lead to an elution of one type of filler.