ASTM F1579-02e1

    Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications (Withdrawn 2011)

    Withdrawn Standard: ASTM F1579-02e1 | Developed by Subcommittee: F04.11

    WITHDRAWN, NO REPLACEMENT


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    Withdrawn Rationale:

    This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). 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.

    Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

    1. Scope

    1.1 This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). 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 (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods that are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.

    1.3 The properties included in this specification are those applicable for PAEK polymers only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PAEK, 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 unfilled PAEK polymers for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirements.

    1.5 When evaluating material to 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 Methods for Dielectric Breakdown Voltage and Dielectric Strength of 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

    D621 Test Methods for Deformation of Plastics Under Load

    D638 Test Method for Tensile Properties of Plastics

    D648 Test Method for Deflection Temperature of Plastics Under Flexural Load

    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 Specific Gravity (Relative Density) and Density of Plastics by Displacement

    D955 Test Method for Measuring Shrinkage from Mold Dimensions of Thermoplastics

    D1238 Test Method for 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 Heats of Fusion and Crystallization of Polymers by Differential Scanning Calorimeter (DSC)

    D3418 Test Methods for Transition Temperatures of Polymers by Differential Scanning Calorimeter (DSC)

    D4000 Classification System for Specifying Plastic Materials

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

    F1876 Specification for Polyetherketoneetherketoneketone (PEKEKK) Resins for Surgical Implant Applications

    F2026 Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

    ISO Documents

    ISO10993 Biological Evaluation of Medical Devices, Parts 1-12

    Other Documents

    FoodandDrugAdministr Regulation 21 CFR 177.2415


    DOI: 10.1520/F1579-02E01

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