ASTM F3087-15
(Specification)Standard Specification for Acrylic Molding Resins for Medical Implant Applications
Standard Specification for Acrylic Molding Resins for Medical Implant Applications
ABSTRACT
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.
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.
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.
General Information
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F3087 −15
Standard Specification for
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Acrylic Molding Resins for Medical Implant Applications
This standard is issued under the fixed designation F3087; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.5 Compliance with this specification does not obviate the
need for functional testing of any device fabricated from the
1.1 This specification covers acrylic resins supplied in
resin to demonstrate effectiveness in its intended application.
virgin form (typically pellets, powder, or granules) for medical
implant applications. The co-polymers are limited to random 1.6 The values stated in SI units are to be regarded as
co-polymers. This specification provides requirements and standard. No other units of measurement are included in this
associated test methods for this thermoplastic when it is standard.
intended for use in manufacturing implantable medical devices
1.7 This standard does not purport to address all of the
or components of medical devices.
safety concerns, if any, associated with its use. It is the
1.1.1 While a variety of co-monomers may be used, the
responsibility of the user of this standard to establish appro-
composition of the resin shall contain poly(methyl methacry-
priate safety and health practices and determine the applica-
late) (PMMA) as its primary ingredient. Classification D788
bility of regulatory limitations prior to use.
defines an acrylic molding compound as “having at least 70%
of the polymer polymerized from methyl methacrylate.” The 2. Referenced Documents
terms PMMA and acrylic as used herein refer generically to 2
2.1 ASTM Standards:
both the homopolymer and to co-polymers as defined above.
D638 Test Method for Tensile Properties of Plastics
1.2 As with any material, some characteristics may be D695 Test Method for Compressive Properties of Rigid
Plastics
altered by the processing techniques (such as molding,
extrusion, machining, sterilization, and so forth) required for D788 Classification System for Poly(Methyl Methacrylate)
(PMMA) Molding and Extrusion Compounds
the production of a specific part or device. Therefore, proper-
ties of fabricated forms of this resin should be evaluated using D792 Test Methods for Density and Specific Gravity (Rela-
test methods that are appropriate to ensure safety and efficacy tive Density) of Plastics by Displacement
as agreed upon between the supplier, purchaser, and regulating D1238 Test Method for Melt Flow Rates of Thermoplastics
bodies. by Extrusion Plastometer
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D1898 Practice for Sampling of Plastics (Withdrawn 1998)
1.3 This specification allows for designation of acrylic
F451 Specification for Acrylic Bone Cement
resins for all medical implant applications.The actual extent of
F748 PracticeforSelectingGenericBiologicalTestMethods
performance and suitability for a specific application shall be
for Materials and Devices
evaluated by the medical device manufacturer and regulating
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2.2 ISO Standards
bodies.
ISO10993-1 Biologicalevaluationofmedicaldevices–Part
1.4 The properties included in this specification are those
1: Evaluation and testing within a risk management
applicable for both unfilled acrylic polymers and for formu-
process
lated resins containing barium sulfate. Indicated properties
ISO 17025 General Requirements for the Competence of
(Table 1 and Table X3.1) are for unfilled injection molded
Testing and Calibration Laboratories
forms. Forms containing fillers other than barium sulfate,
colorants, polymer blends that contain PMMA, or reclaimed
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
materials are not covered by this specification.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
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This test method is under the jurisdiction ofASTM Committee F04 on Medical the ASTM website.
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and Surgical Materials and Devices and is the direct responsibility of Subcommittee The last approved version of this historical standard is referenced on
F04.11 on Polymeric Materials. www.astm.org.
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Current edition approved July 15, 2015. Published July 2015. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F3087-15. 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 States
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