PBI High Performance Plastic CNC machined Component for Medical component ISO 13485 Certificated
Celazole® U-60 is an unfilled polymer suitable for injection molding or CNC machining into precision parts. When it comes to wear and abrasion, PBI has the highest compressive strength of all plastics. Its compressive strength is 57 kpsi and, its modulus strength reaches 850 kpsi compared to grades of Torlon® that start at 440 kpsi.
Before a small spinal implant goes to the patient, it must meet strict universal industry standards for safety, handling, and product consistency. Afterall, a failure in a medical device can have serious repercussions for not only the health and safety of end users, but also loss of credibility and resources for a manufacturer.
That’s why medical device OEMs demand that machining facilities follow the ISO 13485 standard for medical device manufacturing.We have the experience to make the PBI CNC component from Celazole U-60 raw material.