ASTM F3087-15

Anotace textu normy ASTM F3087-15 :

This specification covers requirements and corresponding test methods for acrylic resins supplied in virgin form (typically pellets, powder, or granules) for medical implant applications. The co-polymers are limited to random co-polymers, which shall contain poly(methyl methacrylate) (PMMA) as the primary ingredient and are intended for use in manufacturing implantable medical devices or components of medical devices. They shall undergo appropriate testing to ensure safety and efficacy as agreed upon between the supplier, purchaser, and regulating bodies.This specification includes chemical and mechanical properties that are applicable for both unfilled acrylic polymers and for formulated resins containing barium sulfate. It also covers sampling, appearance, certification, and assessment of selected tissue effects of implant devices made using acrylic polymers.


Keywords:
acrylic resins, co-polymers, molding, PMMA, polymers, surgical applications,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)