ASTM F2820 - 12

    Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

    Active Standard ASTM F2820 | Developed by Subcommittee: F04.11

    Book of Standards Volume: 13.02


      Format Pages Price  
    PDF 6 $42.00   ADD TO CART
    Hardcopy (shipping and handling) 6 $42.00   ADD TO CART


    Abstract

    This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKK polymers for use in medical implant devices. It lists the properties that should be considered in selecting material(s) in accordance with the specific end-use requirements. This specification also addresses classification, properties, sampling, and biocompatibility.

    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. Scope

    1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.

    1.2 As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. With reduced crystallinity, certain polymers have been shown to be more susceptible to environmental stress cracking. Depending upon the implant application, the end user should characterize the material for environmental stress cracking resistance.

    1.3 The properties included in this specification are those applicable for PEKK polymers only. Indicated properties are for fabricated forms. Fabricated forms and materials containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEKK, or reclaimed materials are not covered by this specification.

    1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKK polymers for use in medical implant devices. The properties listed should be considered in selecting material(s) in accordance with the specific end-use requirements.

    1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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.

    ASTM Standards

    D149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies

    D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

    D570 Test Method for Water Absorption of Plastics

    D638 Test Method for Tensile Properties of Plastics

    D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

    D695 Test Method for Compressive Properties of Rigid Plastics

    D696 Test Method for Coefficient of Linear Thermal Expansion of Plastics Between -30C and 30C with a Vitreous Silica Dilatometer

    D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

    D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

    D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics

    D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer

    D1505 Test Method for Density of Plastics by the Density-Gradient Technique

    D1898 Practice for Sampling of Plastics

    D3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)

    D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry

    D4000 Classification System for Specifying Plastic Materials

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    ISO Standards

    ISO13485 Medical devices--Quality Management Systems--Requirements for Regulatory Purposes

    Other Documents

    UnitedStatesPharmaco Vol XXI, or latest edition


    ICS Code

    ICS Number Code 11.040.30 (Surgical instruments and materials)

    UNSPSC Code

    UNSPSC Code


    DOI: 10.1520/F2820-12

    ASTM International is a member of CrossRef.

    ASTM F2820

    Citing ASTM Standards
    Back to Top