SILPURAN® 6000/05 A/B

Reduced volatile content

Medical Equipment

• The following studies were performed on vulcanizates of SILPURAN® 6000/05 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® 6000/05 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.

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® 6000/05 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. Please note that for SILPURAN® 6000/05 A/B use restrictions according to the WACKER SILICONES HEALTH CARE POLICY have to be respected, in particular contact with body tissue or blood is not permitted.
At service temperatures above approx. 180 °C the addition of heat stabilizers is recommended. Further information about an improvement of the heat stability by use of specific ELASTOSIL® Color Pastes FL can be obtained from the Technical Information Sheet "ELASTOSIL® Color Pastes FL" or the latest edition of our brochures.

Cure conditions: 5 min / 165 °C in press, post-cured 4 h / 200 °C

• This product is available in 20 kg pail kits. The packaging of SILPURAN® 6000/05 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