Medical & Healthcare
Medical silicone is a documentation problem as much as a material problem. The compound has to be right, and the paperwork has to survive an audit.
We supply platinum-cured HTV and LSR grades for catheters and cannulae, syringe and connector seals, pump diaphragms, wound-care components and infant feeding parts. Platinum cure is the default here because it leaves no peroxide by-products and keeps extractables low.
We are a raw-material supplier, not a device manufacturer: your device registration and ISO 13485 quality system stay with you. What we provide is batch-level traceability, a COA per lot, and ISO 10993 test data on the specific grade you buy, arranged through a third-party laboratory.
Platinum cure
No peroxide by-products, low extractables, consistent cure across thin walls.
Biocompatibility data
ISO 10993 results on the grade you actually purchase, not on a sister compound.
Lot traceability
Batch records that let you trace a finished part back to a compound lot.
Dimensional stability
LSR for thin walls and tight tolerances that HTV cannot hold.
Material Ranges Used in This Sector
These are the product lines we normally quote for Medical & Healthcare. If your part needs something outside them, tell us the requirement — custom formulation is a normal request, not an exception.
What Ships With the Material
Every lot leaves with paperwork. What changes by sector is which documents your customer will ask to see.
- COA per batch — hardness, tensile strength, elongation, tear strength and specific gravity on the lot you receive.
- TDS — full curing and processing guidance, not a marketing sheet.
- Compliance declarations — FDA, LFGB, RoHS, REACH, PAHS and VOM as applicable to the grade.
- Third-party test reports — arranged on the specific grade you buy, through SGS or an equivalent laboratory.
Certificate copies are available for download, and we can issue a declaration naming your market and application.
Questions Buyers Ask About Medical & Healthcare
No. We hold ISO 9001:2015. ISO 13485 applies to the device manufacturer, which is the role our customers play. We support your audit with compound documentation, but we will not claim a certificate we do not have.
Platinum for anything patient-contacting or where extractables matter. Peroxide cure still has a place in non-medical industrial parts because it is cheaper, but we would not propose it for a medical application.
Yes, on a named grade, through a third-party laboratory. Testing is per-compound, so a report for one hardness does not cover another — we will tell you which tests your chosen grade already has.
