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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.