1. Scope 1.1 This specification covers acrylic resins supplied in virgin form (pellets, powder, and so forth) for medical 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 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. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. 1.3 The standard allows for designation of PMMA resins for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies. 1.4 The properties included in this specification are those applicable for both unfilled PMMA polymers and for formulated resins containing barium sulfate. Indicated properties are for injection molded forms. Forms containing fillers other than barium sulfate, colorants, or other additives, as well as polymer blends which contain PMMA, or reclaimed materials, are not covered by this specification. 1.5 Compliance with this standard does not obviate the need for functional testing of any device fabricated from the resin to demonstrate effectiveness in its intended application. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Devices molded from poly(methyl methacrylate) (PMMA) have a long history of clinical use as permanent implants. For example, distal centralizers, aka cement restrictors, molded from PMMA resins are used to position cemented total hip femoral stems, ensuring an even thickness cement mantle. The extensive and long term use of this class of materials justifies the need for standardization of the polymer properties that are important for device function and biocompatibility. The standard will be usefull for both regulatory and quality control purposes.
polymers; co-polymers; surgical applications; acrylic resins; PMMA; molding
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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