SILPURAN® 6610/40 A/B
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 (≤ 75 kGy). SILPURAN® 6610/40 A/B is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for < 30 days.
SILPURAN® 6610/40 A/B 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 large series of injection molded articles.
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.
SILPURAN® 6610/40 A/B的特殊性能
The following studies were performed on vulcanizates of SILPURAN® 6610/40 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® 6610/40 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® 6610/40 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. Solely contact with acidic foodstuff is not recommended as this might lead to an elution of one type of filler.
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.
For detailed information please refer to the latest edition of our brochure "SOLID AND LIQUID SILICONE RUBBER - MATERIAL AND PROCESSING GUIDELINES".
This product is available in 20 kg pail kits. The packaging of SILPURAN® 6610/40 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.
Once opened, containers should always be resealed after use to prevent the platinum catalyst from being poisoned by amines, sulphur or phosphorus compounds. For detailed information about storage conditions please refer to the latest edition of our brochure "SOLID AND LIQUID SILICONE RUBBER - MATERIAL AND PROCESSING GUIDELINES".
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.