1. Scope
1.1 This specification covers acrylic resins supplied in virgin form (typically pellets,
powder, or granules) for medical implant applications. The co-polymers are limited
to random co-polymers. This specification provides requirements and associated test
methods for this thermoplastic when it is intended for use in manufacturing implantable
medical devices or components of medical devices.
1.1.1 While a variety of co-monomers may be used, the composition of the resin shall contain
poly(methyl methacrylate) (PMMA) as its primary ingredient. Classification D788 defines an acrylic molding compound as “having at least 70% of the polymer polymerized
from methyl methacrylate.” The terms PMMA and acrylic as used herein refer generically
to both the homopolymer and to co-polymers as defined above.