ASTM F3087-15
Standard Specification for Acrylic Molding Resins for Medical Implant Applications

Standard No.

ASTM F3087-15

Release Date

2015

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F3087-15

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.

ASTM F3087-15 Referenced Document

• ASTM D1238 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
• ASTM D1898 
• ASTM D638 Standard Test Method for Tensile Properties of Plastics
• ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
• ASTM D788 Standard Classification System for Poly(Methyl Methacrylate) (PMMA) Molding and Extrusion Compounds
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• ASTM F451 Standard Specification for Acrylic Bone Cement
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]

ASTM F3087-15 history

• 2015 ASTM F3087-15 Standard Specification for Acrylic Molding Resins for Medical Implant Applications