MG-002 · medical-o-ring-seal
Medical Silicone O-Ring
USP Class VI, Class 8 molded
The Medical Silicone O-Ring is a USP Class VI, Class 8 molded. We mold it by LSR injection, Class 8 in a Shore A 50–70 compound, holding ±0.08 mm across production lots, and it complies with ISO 13485 · USP Class VI · ISO 10993-5 · FDA 21 CFR 820. Typical minimum order is 1,000 pcs; series lead time is 20 days.
Precision O-rings molded in a Class 8 cleanroom from USP Class VI LSR. Supplied with lot-level extractables and biocompatibility documentation for device files.
- ±0.08 mm on the sealing diameter
- ISO 10993-5 cytotoxicity tested
- Lot traceable to the press run
Specification
| Hardness | Shore A 50–70 |
|---|---|
| Service temperature | -50–200 °C |
| Achievable tolerance | ±0.08 mm |
| Molding process | LSR injection, Class 8 |
| Typical MOQ | 1,000 pcs |
| Lead time | 20 days |
Compliance
- ISO 13485
- USP Class VI
- ISO 10993-5
- FDA 21 CFR 820
