ASTM F3087-15

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

• Status: Published
• Publication Date: 14-Jul-2015
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Refers: ASTM D1238-23a - Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
• Effective Date: 15-Nov-2023
• Refers: ASTM D1898-68(1989) - Standard Practice for Sampling of Plastics (Withdrawn 1998)
• Effective Date: 29-Sep-2023
• Refers: ASTM D788-16 - Standard Classification System for Poly(Methyl Methacrylate) (PMMA) Molding and Extrusion Compounds
• Effective Date: 01-Sep-2016
• Refers: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Apr-2016
• Refers: ASTM D788-14 - Standard Classification System for Poly(Methyl Methacrylate) (PMMA) Molding and Extrusion Compounds
• Effective Date: 01-Aug-2014
• Refers: ASTM D1238-13 - Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
• Effective Date: 01-Aug-2013
• Refers: ASTM D788-12 - Standard Classification System for Poly(Methyl Methacrylate) (PMMA) Molding and Extrusion Compounds
• Effective Date: 01-Aug-2012
• Refers: ASTM D788-11 - Standard Classification System for Poly(Methyl Methacrylate) (PMMA) Molding and Extrusion Compounds
• Effective Date: 01-Dec-2011
• Refers: ASTM F748-06(2010) - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Jun-2010
• Refers: ASTM D638-10 - Standard Test Method for Tensile Properties of Plastics
• Effective Date: 15-May-2010
• Refers: ASTM D695-10 - Standard Test Method for Compressive Properties of Rigid Plastics
• Effective Date: 01-Apr-2010
• Refers: ASTM D695-08 - Standard Test Method for Compressive Properties of Rigid Plastics
• Effective Date: 01-Aug-2008
• Refers: ASTM F451-08 - Standard Specification for Acrylic Bone Cement
• Effective Date: 01-Aug-2008
• Refers: ASTM D792-08 - Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• Effective Date: 15-Jun-2008
• Refers: ASTM F451-99a(2007)e1 - Standard Specification for Acrylic Bone Cement
• Effective Date: 01-Dec-2007

Overview

ASTM F3087-15 is the internationally recognized standard specification for acrylic molding resins used in medical implant applications. Developed by ASTM, this standard establishes the requirements and correlated test methods for acrylic resins-primarily poly(methyl methacrylate) (PMMA) compositions-supplied in virgin form as pellets, powder, or granules. The specification is tailored for PMMA homopolymers and random co-polymers intended for manufacturing long-term or permanent implantable medical devices or components.

ASTM F3087-15 plays a critical role in ensuring that materials used in life-saving and life-enhancing medical implants adhere to rigorous quality, safety, and performance standards. It also provides guidance for sampling, appearance, certification, and biological assessment, fostering confidence for medical device manufacturers, regulatory bodies, and end-users.

Key Topics

• Scope of Coverage

  • Applies to virgin acrylic resins (usually PMMA or random co-polymers with PMMA as the primary ingredient).
  • Suitable for production of medical devices intended for prolonged (>24 hours) or permanent (>30 days) implantation.
  • Includes both unfilled acrylics and those formulated with barium sulfate.
  • Requires evaluation of properties after all processing steps, including sterilization.

• Material Requirements

  • Composition must have at least 70% PMMA by polymerized monomer content.
  • Chemical and mechanical property benchmarks must be met, including density, residual monomer content, and melt flow index.
  • Strict limits on particulate contamination and residual monomer (not exceeding 0.5%).

• Testing and Certification

  • Mechanical properties assessed per relevant ASTM methods (e.g., D638 for tensile properties, D695 for compressive strength).
  • Biocompatibility must be verified using standards such as ISO 10993-1 or ASTM F748.
  • Certification of compliance with process control, validated testing, and sampling protocols.
  • Use of ISO 17025 accredited laboratories is recommended.

• Manufacturing and Processing

  • Consistency ensured through adherence to Good Manufacturing Practices (GMPs).
  • Recognition that processing methods (molding, extrusion, sterilization) can impact properties; thus, testing after processing is required.
  • Only specific fillers (e.g., barium sulfate for radiopacity) are allowed. Other fillers, colorants, or recycled materials are excluded.

Applications

Acrylic molding resins specified in ASTM F3087-15 are primarily used for:

• Implantable medical device components:

  • Orthopedic implants (such as cranioplasty materials and cement restrictors for hip stems)
  • Dental and maxillofacial implants
  • Other long-term internal prosthetics

• Medical devices with tissue or fluid contact exceeding 24 hours

• Uses where optimal combination of mechanical strength, chemical stability, and biocompatibility is required

Manufacturers rely on these materials for their extensive clinical history, predictable tissue response, and compatibility with common sterilization methods (e.g., ethylene oxide, irradiation). The standard ensures consistency, supporting regulatory submissions and market acceptance.

Related Standards

ASTM F3087-15 references several important standards and methods to ensure a comprehensive framework:

• ASTM D638 – Test Method for Tensile Properties of Plastics
• ASTM D695 – Test Method for Compressive Properties of Rigid Plastics
• ASTM D788 – Classification System for PMMA Molding and Extrusion Compounds
• ASTM D1238 – Test Method for Melt Flow Rates of Thermoplastics
• ASTM F451 – Specification for Acrylic Bone Cement
• ASTM F748 – Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ISO 10993-1 – Biological Evaluation of Medical Devices
• ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories

By aligning with these standards, ASTM F3087-15 facilitates compliance, approval, and global interoperability for acrylic molding resins in medical implant applications.

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Keywords: ASTM F3087-15, acrylic molding resins, PMMA, medical implants, biocompatibility, implantable devices, medical device materials, standard specification, mechanical properties, ISO 10993, tensile strength, acrylic copolymers.

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
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
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
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
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
materials are not covered by this specification.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
This test method is under the jurisdiction ofASTM Committee F04 on Medical the ASTM website.
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.
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
F3087−15
2.3 Other Reference: 4.3 Acrylic resins intended for use in implant applications
Klaus-Dieter Kuhn, “Up-to-Date Comparison of Physical are manufactured with more rigorous use of manufacturing or
and Chemical Properties of Commercial Materials,” Bone testing controls, or both, to ensure consistency of properties,
Cements, Springer, 2000. cleanliness, and biocompatibility. This is further elaborated in
5.1.
3. Terminology
5. Classification
3.1 Definitions:
5.1 Acrylic resins meeting the requirements of this specifi-
3.1.1 formulated resin, n—materials, parts, or devices fab-
cation may be considered for use for either prolonged or
ricated from virgin polymer resin in such a way as to contain
permanent medical implant applications. Resins classified for
intentional or unintentional adjuvant substances.
permanent implant applications may require additional testing
3.1.2 poly(methyl methacrylate) (PMMA), n—homopolymer
beyondthatrequiredforprolongeduseasagreeduponbetween
of methyl methacrylate (MMA), or random copolymer of
the device manufacturer and regulating bodies. Use of resins
MMA with other vinyl monomers in which MMA constitutes
for implant applications also implies a higher degree of
the majority of the final content.
manufacturing control. Implant grade resins shall be in com-
3.1.3 virgin polymer, n—the initially delivered form of the
pliance with the relevant aspects of Good Manufacturing
polymer as synthesized from its monomers prior to any
Practices (GMPs), use of process validation, enhanced
processing or fabrication into a medical device. The resin is
controls, and testing in a laboratory meeting the requirements
typically provided in the form of pellets, granules, or powder
of ISO 17025.Acrylic resins classified for implantable devices
and is the material from which fibers, tubes, rods, slabs, sheets,
shall be evaluated for biological response in accordance with
films, or specific parts and devices are fabricated.
ISO 10993-1 or Practice F748, Section 10, or both.
NOTE 1—Implant uses are medical applications implanted in the human
4. Significance and Use
body and devices that are in contact with bodily fluids or tissues for
4.1 This specification identifies the composition and recom-
greater than 24 h; that is, prolonged (24 h to 30 days) or permanent (> 30
mends test methods to establish a reasonable level of confi- days) exposure. Non-implant uses are medical applications in which the
device is in contact with bodily fluids or tissues for 24 h or less (that is,
dence concerning the performance of acrylic resins for use in
limited exposure).
medical implant devices. The required properties are intended
5.2 The class and grade of unfilled acrylic plastic shall be
to provide a means of ensuring consistent performance. Addi-
designated in accordance with Classification D788.
tional testing should be considered in selecting a material in
accordance with specific end-use requirements.
6. Chemical Composition
4.2 Acrylic resins may be considered for use in implantable
6.1 The acrylic resin shall be a homopolymer of MMAor a
medical devices as well as in non-implant medical
random co-polymer of MMAand other vinyl monomers where
applications, but this standard specifically covers resins used
MMAconstitutesthemajorityofthecomposition.Noadditives
for implants. Resins meeting the requirements of this specifi-
other than radiopaque fillers or stabilizers shall be used.
cation may be suitable for non-implant applications, but other
acrylic resins that do not conform to this standard may also be 6.2 The acrylic resin shall yield an infrared transmittance
suitable for use in non-implant medical applications.
spectrum that exhibits major transmittance bands at the same
NOTE 1—Spectrum courtesy of Wright Medical Technology, Memphis, TN. Nicolet Magna IR spectrometer, Attenuated Total Reflectance mode.
FIG. 1Poly(Methyl Methacrylate) Homopolymer Infrared Spectrum
F3087−15
wavelengths as shown in Fig. 1. The purpose of the infrared 8. Appearance
(IR) spectrum, as used in this specification, is to identify the
8.1 The resin shall be inspected for particulate foreign
PMMApresent and does not necessarily indicate an acceptable
matter contamination using the following or an equivalent
degree of material purity. The presence of additional bands in
procedure:
the IR spectrum of a sample may indicate a co-polymer
8.1.1 Spread a 100-g sample of the resin onto a flat, white
fraction, or impurities, or both.
surface and visually inspect (20/20 corrected vision if neces-
6.3 The acrylic resin (prior to formulation or molding) shall sary) at a distance of 18 to 20 in. No more than 4 visible
meet the requirements of Table 1 as determined using a particles smaller than 0.5 mm shall be allowed. No particles
validate
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