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This specification covers polyetheretherketone (PEEK) polymer in virgin forms as 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. The PEEK polymer in the scope of this specification is a pure semicrystalline homopolymer consisting of phenylene rings connected by ether (E) and carbonyl (or ketone, K) groups along the polymer chain. Its polymeric structure is defined by the repeating unit EEK. 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 shall be evaluated using appropriate test methods such as US Pharmacopeia test (infrared spectroscopy, viscosity measurements, and total heavy metal content (as lead)), and differential scanning calorimetry. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. The properties which shall be evaluated are the following: density, tensile strength, elongation, flexural strength, flexural modulus, and impact strength. The biocompatibility of PEEK polymers is also detailed.
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.
Significance and Use
1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, 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 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.
1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
D256 Test Methods for Determining the Izod Pendulum Impact Resistance 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
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1898 Practice for Sampling of Plastics
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 StandardsISO13485 Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes
ICS Number Code 11.040.30 (Surgical instruments and materials)
UNSPSC Code 42294802(Flexible endoscopes or accessories or related products); 12162002(Polymerics)