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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 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.
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 that are appropriate to ensure safety and efficacy as agreed upon between the supplier, purchaser, and regulating bodies.
1.3 This specification allows for designation of acrylic resins for all medical implant applications. The actual extent of performance and suitability for a specific application shall be evaluated by the medical device manufacturer and regulating bodies.
1.4 The properties included in this specification are those applicable for both unfilled acrylic polymers and for formulated resins containing barium sulfate. Indicated properties (Table 1 and Table X3.1) are for unfilled injection molded forms. Forms containing fillers other than barium sulfate, colorants, polymer blends that contain PMMA, or reclaimed materials are not covered by this specification.
1.5 Compliance with this specification 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 This standard does not purport to address all of the safety 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D638 Test Method for Tensile Properties of Plastics
D695 Test Method for Compressive Properties of Rigid Plastics
D788 Classification System for Poly(Methyl Methacrylate) (PMMA) Molding and Extrusion Compounds
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1898 Practice for Sampling of Plastics
F451 Specification for Acrylic Bone Cement
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO StandardsISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 17025
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 13111064(Acrylic resins); 42295509(Plastic or cosmetic implants or tissue expanders or sets)
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ASTM F3087-15, Standard Specification for Acrylic Molding Resins for Medical Implant Applications, ASTM International, West Conshohocken, PA, 2015, www.astm.orgBack to Top