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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Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by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.
1.1 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.
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 DocumentsISO10993 Biological Evaluation of Medical Devices, Parts 1-12
Other DocumentsFoodandDrugAdministr Regulation 21 CFR 177.2415