1、Designation: F2026 14F2026 16Standard Specification forPolyetheretherketone (PEEK) Polymers for Surgical ImplantApplications1This standard is issued under the fixed designation F2026; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,
2、 the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pe
3、llets, powder,fabricated forms, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to beused in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.1.2 The properties included in this
4、specification are those applicable for PEEK polymers only. Indicated properties are forfabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blendswhich contain PEEK, or reclaimed materials, are not covered by this specification.1
5、.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable levelof 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
6、 units of measurement are included in this standard.1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may beinvolved. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the resp
7、onsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D256 Test Methods for Determining the Izod Pendulum Impact Resistance of PlasticsD638 Test Meth
8、od for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise PositionD695 Test Method for Compressive Properties of Rigid PlasticsD790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insul
9、ating MaterialsD792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differe
10、ntialScanning CalorimetryD4000 Classification System for Specifying Plastic MaterialsF748 Practice for Selecting Generic Biological Test Methods for Materials and Devices2.2 ISO Standards:3ISO 178 PlasticsDetermination of Flexural PropertiesISO 180 PlasticsDetermination of Izod Impact StrengthISO 52
11、7 PlasticsDetermination of Tensile PropertiesPart 1: General PrinciplesISO 1183 PlasticsMethods for Determining the Density of Non-cellular PlasticsPart 2: Density Gradient Column MethodISO 10993 Biological Evaluation of Medical Devices, Parts 1-12ISO 13485 Medical DevicesQuality Management SystemsR
12、equirements for Regulatory Purposes1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved March 1, 2014April 1, 2016. Published May 2014M
13、ay 2016. Originally approved in 2000. Last previous edition approved in 20122014 asF2026 12.F2026 14. DOI: 10.1520/F2026-14.10.1520/F2026-16.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolum
14、e information, refer to the standards Document Summary page on the ASTM website.3 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.This document is not an ASTM standard and is intended only to provide the user of an ASTM s
15、tandard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by
16、ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.3 Other Documents:United States Pharmacopeia, Vol. XXI, or latest edition43. Terminology3.1 Definitions of Terms Specific to This Standar
17、d:3.1.1 fabricated forms, nthose items into which the virgin forms may be converted. These include shapes and forms producedby means of machining, extruding, and compression molding virgin forms into a subsequent entity (for example, fibers, tubes, rods,slabs, sheets, film, or complex shaped parts a
18、nd devices).3.1.2 formulated compound, nmaterials, parts, or devices fabricated from virgin forms in such a way as to contain intentionalor unintentional adjuvant substances.3.1.3 virgin forms, nthe initially delivered form of the polymer as synthesized from its monomers prior to any processing orfa
19、brication into a medical device. The provided resin is typically in the form of pellets, granules, or powder and is the materialfrom which fibers, tubes, rods, slabs, sheets, films, or specific parts and devices are fabricated.4. Classification4.1 The PEEK polymer in the scope of this specification
20、is a pure semicrystalline homopolymer consisting of phenylene ringsconnected by ether (E) and carbonyl (or ketone, K) groups along the polymer chain (see Appendix X1). Its polymeric structureis defined by the repeating unit EEK.4.2 Types of PEEK plastics, molding, and extrusion grades are described
21、in Classification System D4000.5. Properties5.1 The properties listed below shall be considered in selecting material(s) in accordance with the specific end-use requirements.5.2 The infrared spectrum5 of these materials is characteristic of their molecular repeating units. A representative spectrum
22、islisted in Appendix X3. The PEEK polymer shall yield an infrared spectrum, which exhibits major bands only at the wavelengthslisted for a standard reference spectrum of that material.5.2.1 The infrared spectrum, as used in this specification, is to identify the specific type of poly aryl ether keto
23、ne (PAEK) presentand does not necessarily indicate an acceptable degree of material purity.5.2.2 The presence of additional bands in the samples infrared spectrum compared to that of the reference material may indicatea different PAEK or impurities, or both.5.3 The physical and chemical property req
24、uirements for the virgin polymer are listed in Table 1. If additional characteristicsare necessary because of a specific application, the procedures referenced in Section 2 are recommended, or as agreed uponbetween the vendor and the purchaser.4 Available from U.S. Pharmacopeia (USP), 12601 Twinbroo
25、k Pkwy., Rockville, MD 20852-1790, http:/www.usp.org.5 Silverstein, R. M., Bassler, G. C., and Morrill, T. C., Spectroscopic Identification of Organic Compounds, 5th ed., John Wiley polyetheretherketoneAPPENDIXES6 Hay, J. N., and Kemmish, D. J., “Environmental Stress Crack Resistance and Absorption
26、of Low-Molecular-Weight Penetrants by Poly(Aryl Ether Ether Ketone),”Polymer, Vol 29, April 1988, pp. 613618.7 Srivastava, A. P., Depke, N., and Wolf, C. J., “Environmental Stress Deformation of Poly(ether ether ketone),” J. Applied Polymer Science, Vol 66, 1997, pp. 725731.8 Kurtz, S.M. and Devine,
27、 J.N., “PEEK Biomaterials in Trauma, Orthopedic, and Spinal Implants,” Biomaterials, Vol 28, No. 32, 2007, pp. 4845-4869.TABLE 2 Required Properties of Fabricated FormsParameter ISO Methods and Requirements ASTM Methods and RequirementsDensity, kg/m3 ISO 1183 1280 - 1320 ASTM D792 orASTM D15051280 -
28、 1320Tensile Strength: ISO 527, Type 1B,50 mm/minASTM D638,Type IV, 5.08 cm/minat yield (zero slope), min, MPa 90 90at break, min, MPa 70 70Elongation at break,A min, % ISO 527, Type 1B,50 mm/min5 ASTM D638,Type IV, 5.08 cm/min5Flexural strength, min, MPa ISO 178 110 ASTM D790 110Flexural modulus, m
29、in, GPa ISO 178 3 ASTM D790 3Impact strength,notched Izod, minISO 180 4 (kJ/m2) ASTM D256, 0.254 cm depth,0.025 cm radius50 (J/m)A Use an extensometer for measuring strain and calculating percent elongation.F2026 163(Nonmandatory Information)X1. RATIONALEX1.1 The PEEK polymers may be processed by mo
30、st techniques available for thermoplastic polymers. Medical devices andcomponents of medical devices made of PEEK polymers may be sterilized. Sterilization methods successfully used include steam,ethylene oxide, and irradiation. Repeated sterilization may weaken parts fabricated of any plastic mater
31、ial. The number of timesa given part may be sterilized safely without fear of subsequent failure depends on a number of factors including the molecularweight of the polymer and design, fabrication, intended function, and method of sterilization of the device. Therefore, it isimperative that the manu
32、facturer test the device in order to determine the maximum number of sterilization cycles to which it canbe safely subjected.X1.2 The potential to develop a significant level of crystallinity is an important characteristic of these materials. Performancecharacteristics are related to the percent cry
33、stallinity. Certain additives and processes (for example, excessive cross linking) canlimit these materials ability to crystallize. Therefore, this feature of the polymer and its fabricated form should be evaluated, usingappropriate test methods, to ensure efficacy.X1.3 A formulated compound or fabr
34、icated part or device may contain optional adjuvant substances required for the fabricationor intended use of the end product. The biocompatibility of these adjuvant substances, and subsequent formulated compounds,parts, and devices shall be established in accordance with Practice F748 or the ISO 10
35、993 series.X2. CHEMICAL STRUCTURE OF PEEKX3. REPRESENTATIVE INFRARED SPECTRA OF PEEKF2026 164RELATED MATERIALAutian, J., “Toxicological Evaluation of Biomaterials: Primary Acute Toxicity Screening Program,” Journal of Artificial Organs, Vol 1, No. 1, 1977,p. 53.Autian, J., “The New Field of Plastic
36、Toxicological Methods and Results,” CRC Critics Review in Toxicology, 1973, p. 18.Homsy, C. A., Ansevin, K. D., OBrannon, W., Thompson, S. H., Hodge, R., and Estrella, M. E., “Rapid In Vitro Screening of Polymers forBiocompatibility,” Journal of Macromolecular Science Chemistry, Vol A4, No. 3, May 1
37、970, pp. 615-634.Rice, R. M., Hegyeli, A. F., Gourlay, S. J., Wade, C. W. R., Dillon, J. G., Jaffe, H., and Kulkarni, R. K., “Biocompatibility Testing for Polymers: InVitro Studies With In Vivo Correlation,” Journal of Biomedical Materials Research, Vol 12, 1978, p. 43.ASTM International takes no po
38、sition respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibi
39、lity.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn.Your comments are invited either for revision of this standard or for additional standardsand should be addressed to AS
40、TM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address
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