Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Plastics & Elastomers Functions
- Technologies
Features & Benefits
- Labeling Claims
- Materials Features
- Specific Features
- Food-contact
- Medical
- X-ray opaque
Applications & Uses
- Markets
- Compatible Polymers & Resins
- Cure Method
- Plastics & Elastomers End Uses
- Applications
Medical Equipment
- Application Details
- SILPURAN® AUX 8250 RO is used as an additive to get a radio opaque high consistency silicone rubber. The following studies were performed on vulcanizates of SILPURAN® AUX 8250 RO 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® AUX 8250 RO 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 a suited HTV and SILPURAN® AUX 8250 RO 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
- SILPURAN® AUX 8250 RO and the high consistency silicone base rubber are mixed homogenously on a roll mill. The mixing ratio depends on the required concentration.
- For detailed information please refer to the latest edition of our brochure "SOLID AND LIQUID SILICONE RUBBER - MATERIAL AND PROCESSING GUIDELINES".
- SILPURAN® AUX 8250 RO is used as an additive to get a radio opaque high consistency silicone rubber. The following studies were performed on vulcanizates of SILPURAN® AUX 8250 RO according to ISO 10993:
Properties
- Color
- Physical Form
- Uncured Properties
- Properties
- SILPURAN® AUX 8250 RO contains approx. 75 % barium sulfate which meets the requirements of the US and European Pharmacopeia.
- SILPURAN® AUX 8250 RO is intended particularly for use with peroxide cure high consistency silicone rubber. For addition cure high consistency rubber, SILPURAN® AUX 8251 RO is the better choice.
- SILPURAN® AUX 8250 RO meets selected test requirements of ISO 10993 and United States Pharmacopeia (USP) Class VI.
| Value | Units | Test Method / Conditions | |
| Density | 2.24 | g/cm³ | DIN EN ISO 1183-1 A |
Regulatory & Compliance
- Certifications & Compliance
Packaging & Availability
- Country Availability
- Packaging Type
- Regional Availability
- Packaging Information
- SILPURAN® AUX 8250 RO 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® AUX 8250 RO 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.
Storage & Handling
- Storage Information
Please store the cardboard boxes in a dry and cool place. Once opened, cardboard boxes should always be resealed after use to avoid any contamination.