ASTM_F_3087_-_15.pdf

Designation:F308715Standard Specification forAcrylic Molding Resins for Medical Implant Applications1This standard is issued under the fixed designation F3087;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers acrylic resins supplied invirgin form(typically pellets,powder,or granules)for medicalimplant applications.The co-polymers are limited to randomco-polymers.This specification provides requirements andassociated test methods for this thermoplastic when it isintended for use in manufacturing implantable medical devicesor components of medical devices.1.1.1 While a variety of co-monomers may be used,thecomposition of the resin shall contain poly(methyl methacry-late)(PMMA)as its primary ingredient.Classification D788defines an acrylic molding compound as“having at least 70%of the polymer polymerized from methyl methacrylate.”Theterms PMMA and acrylic as used herein refer generically toboth the homopolymer and to co-polymers as defined above.1.2 As with any material,some characteristics may bealtered by the processing techniques(such as molding,extrusion,machining,sterilization,and so forth)required forthe production of a specific part or device.Therefore,proper-ties of fabricated forms of this resin should be evaluated usingtest methods that are appropriate to ensure safety and efficacyas agreed upon between the supplier,purchaser,and regulatingbodies.1.3 This specification allows for designation of acrylicresins for all medical implant applications.The actual extent ofperformance and suitability for a specific application shall beevaluated by the medical device manufacturer and regulatingbodies.1.4 The properties included in this specification are thoseapplicable for both unfilled acrylic polymers and for formu-lated resins containing barium sulfate.Indicated properties(Table 1 and Table X3.1)are for unfilled injection moldedforms.Forms containing fillers other than barium sulfate,colorants,polymer blends that contain PMMA,or reclaimedmaterials are not covered by this specification.1.5 Compliance with this specification does not obviate theneed for functional testing of any device fabricated from theresin to demonstrate effectiveness in its intended application.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD788 Classification System for Poly(Methyl Methacrylate)(PMMA)Molding and Extrusion CompoundsD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1898 Practice for Sampling of Plastics(Withdrawn 1998)3F451 Specification for Acrylic Bone CementF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standards4ISO 10993-1 Biological evaluation of medical devices Part1:Evaluation and testing within a risk managementprocessISO 17025 General Requirements for the Competence ofTesting and Calibration Laboratories1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved July 15,2015.Published July 2015.DOI:10.1520/F3087-15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.3Other Reference:Klaus-Dieter Kuhn,“Up-to-Date Comparison of Physicaland Chemical Properties of Commercial Materials,”BoneCements,Springer,2000.3.Terminology3.1 Definitions:3.1.1 formulated resin,nmaterials,parts,or devices fab-ricated from virgin polymer resin in such a way as to containintentional or unintentional adjuvant substances.3.1.2 poly(methyl methacrylate)(PMMA),nhomopolymerof methyl methacrylate(MMA),or random copolymer ofMMA with other vinyl monomers in w