SILPURAN® 6760/50 A/B

• Food-contact
• Less self-healing
• Low coefficient of friction
• Reduced volatile content
• Self-adhesive

Medical Equipment

• The following studies were performed on vulcanizates of SILPURAN® 6760/50 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® 6760/50 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® 6760/50 A/B can be used for food contact applications and are suitable for use under the Recommendation "XV. Silicones" of the BfR and FDA 21 CFR §177.2600 "Rubber Articles Intended for Repeated Use" considering any given limitations on extractable and volatile substances.

Processing

The A and B components are delivered ready to use in 20 kg pail kits. With adequate metering equipment, they can be pumped directly from the original containers into the injection molding machine and mixed by a static mixer. The mixing ratio is 1 : 1. At room temperature, mixtures of A and B components have a pot life of at least three days.

SILPURAN® 6760/50 A/B meets selected test requirements of ISO 10993 and United States Pharmacopeia (USP) Class VI. It is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for <30 days and is particularly suitable for the economical production of large series of injection molded articles.

SILPURAN® 6760/50 A/B is a primerless selfbonding grade that adheres to various thermoplasts (e.g. PA, PBT) and metals. The bonding is improved by an aging process (e.g. one hour at 100°C) or by a longer storage at room temperature. Because of the individual surface properties each substrate must be tested before starting mass production. If necessary, one has to check the development of adhesive properties over time and/or in an environment relevant to the application. Compared to the SILPURAN® 6000 series the coefficient of friction of an article of SILPURAN® 6760 is reduced by 50 - 70 %.

At service temperatures above approx. 180°C the addition of heat stabilizers is recommended.

Cure conditions: 5 min / 165 °C in press, non post-cured

• This product is available in 20 kg pail kits. The packaging of SILPURAN® 6760/50 A/B is performed in accordance with class 8 clean room standards (DIN EN ISO 14644).
• SILPURAN® is neither produced nor packed under sterile conditions, so the final product has to be sterilized prior to use, if necessary.