SILPURAN® 8461/60 is a peroxide cure, two component high consistency silicone rubber for the manufacture of extruded articles. Vulcanizates are noted for their high tear resistance and high transparency.
SILPURAN® 8461/60 is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for < 30 days.
SILPURAN® 8461/60 meets selected test requirements of ISO 10993 and United States Pharmacopoeia (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 extruded articles exhibiting high tear resistance.
At service temperatures above approx. 180 °C the addition of suitable heat stabilizers is recommended. Further information about an improvement of the heat stability by use of specific ELASTOSIL® AUX Heat Stabilizers can be obtained from the Technical Information Sheet "ELASTOSIL® AUX Stabilizers H" or the latest edition of our brochures.
The following studies were performed on vulcanizates of SILPURAN® 8461/60 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® 8461/60 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® 8461/60 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.
SILPURAN® 8461/60 is recommended to be cured by crosslinker E. SILPURAN® 8461/60 and the recommended amount of crosslinker E are mixed homogeneously on a roll mill. Care must be taken to keep the mill and compound as cool as possible during mixing.
For detailed information please refer to the latest edition of our brochure "SOLID AND LIQUID SILICONE RUBBER - MATERIAL AND PROCESSING GUIDELINES".
SILPURAN® HCR is delivered in blocks (profile diameter = approx. 90 x 100 mm) that are wrapped in an antistatic film and heatsealed in a bag. The customer can thus be sure that the material is not contaminated before it enters the cleanroom. SILPURAN® HCR is packaged 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.
Please store the cardboard boxes in a dry and cool place. Already opened boxes should be closed again to avoid any contamination.
The 'Best use before end' date of each batch is shown on the product label. Storage beyond the date specified on the label does not necessarily mean that the product is no longer usable. In this case however, the properties required for the intended use must be checked for quality assurance reasons.