1、Designation: F2026 10Standard 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, the yea
2、r 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 (pellets,pow
3、der, fabricated forms, and so forth). It provides require-ments and associated test methods for these thermoplasticswhen they are to be used in the manufacture of intracorporealdevices such as surgical implants or components of surgical ordental devices.1.2 As with any material, some characteristics
4、 may bealtered by the processing techniques (molding, extrusion,machining, assembly, sterilization, and so forth) required forthe production of a specific part or device. Therefore, proper-ties of fabricated forms of this polymer should be evaluatedusing test methods which are appropriate to ensure
5、safety andefficacy as agreed upon by the vendor, purchaser, and regulat-ing bodies.1.3 The properties included in this specification are thoseapplicable for PEEK polymers only. Indicated properties arefor fabricated forms. Materials or forms containing colorants,fillers, processing aids, or other ad
6、ditives, as well as polymerblends which contain PEEK, or reclaimed materials, are notcovered by this specification.1.4 This specification is designed to recommend physical,chemical, and biological test methods to establish a reasonablelevel of confidence concerning the performance of virginPEEK poly
7、mers for use in medical implant devices. Theproperties 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 asstandard. No other units of measurement are included in thisstandard.1.6 When evaluat
8、ing material in accordance with this speci-fication, hazardous materials, operations, and equipment maybe involved. This standard does not purport to address all ofthe safety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate saf
9、ety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD256 Test Method
10、s for Determining the Izod PendulumImpact Resistance of PlasticsD570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise PositionD695 Test Method for Compressive Prop
11、erties of RigidPlasticsD696 Test Method for Coefficient of Linear Thermal Ex-pansion of Plastics Between 30C and 30C with aVitreous Silica DilatometerD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsD792 Test Methods for Density and
12、Specific Gravity (Rela-tive Density) of Plastics by DisplacementD955 Test Method of Measuring Shrinkage from MoldDimensions of ThermoplasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1898
13、 Practice for Sampling of Plastics3D3417 Test Method for Enthalpies of Fusion and Crystal-lization of Polymers by Differential Scanning Calorimetry(DSC)3D3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD4000 Cl
14、assification System for Specifying Plastic Materi-als1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Sept. 1, 2010. Published Septem
15、ber 2010. Originallyapproved in 2000. Last previous edition approved in 2008 as F2026 08. DOI:10.1520/F2026-10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the s
16、tandards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 ISO Standards:4ISO 178 PlasticsDet
17、ermination of Flexural PropertiesISO 180 PlasticsDetermination of Izod Impact StrengthISO 527 PlasticsDetermination of Tensile PropertiesPart 1: General PrinciplesISO 1183 PlasticsMethods for Determining the Densityof Non-cellular PlasticsPart 2: Density Gradient Col-umn MethodISO 10993 Biological E
18、valuation of Medical Devices, Parts1-122.3 Other Documents:United States Pharmacopeia, Vol. XXI, or latest edition53. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 fabricated forms, nthose items into which the virginforms may be converted. These include shapes and formsproduced
19、 by means of machining, extruding, and compressionmolding virgin forms into a subsequent entity (for example,fibers, tubes, rods, slabs, sheets, film, or complex shaped partsand devices).3.1.2 formulated compound, nmaterials, parts, or devicesfabricated from virgin forms in such a way as to containi
20、ntentional or unintentional adjuvant substances.3.1.3 virgin forms, nthat form of the polymer as obtainedby the synthesizer. It typically will be in the form of pellets orpowder. It is the material from which fibers, tubes, rods, slabs,sheets, films, or specific parts and devices are fabricated.4. C
21、lassification4.1 The PEEK polymer in the scope of this specification isa pure semicrystalline homopolymer consisting of phenylenerings connected by ether (E) and carbonyl (or ketone, K)groups along the polymer chain (see Appendix X1). Itspolymeric structure is defined by the repeating unit EEK.4.2 T
22、ypes of PEEK plastics, molding, and extrusion gradesare described in Classification System D4000.5. Properties5.1 The infrared spectrum6of these materials is character-istic of their molecular repeating units. A representative spec-trum is listed in Appendix X3. The PEEK polymer shall yieldan infrar
23、ed spectrum, which exhibits major bands only at thewavelengths listed for a standard reference spectrum of thatmaterial.5.1.1 The infrared spectrum, as used in this specification, isto identify the specific type of poly aryl ether ketone (PAEK)present and does not necessarily indicate an acceptable
24、degreeof material purity.5.1.2 The presence of additional bands in the samplesinfrared spectrum compared to that of the reference materialmay indicate a different PAEK or impurities, or both.5.2 The physical and chemical property requirements for thevirgin polymer are listed in Table 1. If additiona
25、l characteristicsare necessary because of a specific application, the proceduresreferenced in Section 2 are recommended, or as agreed uponbetween the vendor and the purchaser.5.3 The viscosity requirements will vary depending uponthe grade and test method. The method and requirements shallbe agreed
26、upon between the vendor and the purchaser.5.4 The chemical, physical, and mechanical properties offabricated forms are related to the processes utilized inproducing the fabricated form (for example, molding, machin-ing, sterilization, and so forth). Additionally, the propertiesnecessary for a partic
27、ular device to perform properly will varyfrom one device type to another. Table 2 lists some typicalproperties of non-sterilized fabricated forms.5.5 Test specimens shall be fabricated (machined, injectionmolded, and so forth) from the virgin polymer, or finished part,in such a way as to effectively
28、 represent the material charac-teristics of the non-sterilized finished part.5.6 Tests and test procedures shall be such as to ensure ahigh level of control and characterization of the virgin polymeras received from the supplier. The test methods referenced in4Available from American National Standa
29、rds Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.6Silverstein, R. M., Bassler, G. C., and Morrill, T. C., Spectroscopic Identifi-cation of Organic Compound
30、s, 5th ed., John Wiley polyetheretherketoneAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The PEEK polymers may be processed by mosttechniques available for thermoplastic polymers. Medical de-vices and components of medical devices made of PEEKpolymers may be sterilized. Sterilization methods
31、 successfullyused include steam, ethylene oxide, and irradiation. Repeatedsterilization may weaken parts fabricated of any plastic mate-rial. The number of times a given part may be sterilized safelywithout fear of subsequent failure depends on a number offactors including the molecular weight of th
32、e polymer anddesign, fabrication, intended function, and method of steriliza-tion of the device. Therefore, it is imperative that the manu-facturer test the device in order to determine the maximumnumber of sterilization cycles to which it can be safelysubjected.X1.2 The potential to develop a signi
33、ficant level of crys-tallinity is an important characteristic of these materials.Performance characteristics are related to the percent crystal-linity. Certain additives and processes (for example, excessivecross linking) can limit these materials ability to crystallize.Therefore, this feature of th
34、e polymer and its fabricated formshould be evaluated, using appropriate test methods, to ensureefficacy.X1.3 A formulated compound or fabricated part or devicemay contain optional adjuvant substances required for thefabrication or intended use of the end product. The biocom-patibility of these adjuv
35、ant substances, and subsequent formu-lated compounds, parts, and devices shall be established inaccordance with Practice F748 or the ISO 10993 series.7Kurtz, S.M. and Devine, J.N., “PEEK Biomaterials in Trauma, Orthopedic, andSpinal Implants,” Biomaterials, Vol 28, No. 32, 2007, pp. 4845-4869.TABLE
36、2 Typical Properties of Fabricated FormsParameter ISO Methods and Requirements ASTM Methods and RequirementsDensity, kg/m3ISO 1183 1280 - 1320 ASTM D1505 1280 - 1320Tensile Strength ISO 527, Type 1B, ASTM D638,50 mm/min Type IV, 5.08 cm/minat Yield (Zero Slope), MPaat break, MPa90709070Percent elong
37、ation at break,A%ISO 527, Type 1B,50 mm/min5 ASTM D638,Type IV, 5.08 cm/min5Flexural Strength, MPa ISO 178 110 ASTM D790 110Flexural Modulus, GPa ISO 178 3 ASTM D790 3Impact Strength, Notched Izod ISO 180 4 (kJ/m2) ASTM D256,0.254 cm depth, 0.025 cm radius50 (J/m)AUse an extensometer for measuring s
38、train and calculating percent elongation.F2026 103X2. CHEMICAL STRUCTURE OF PEEKX3. REPRESENTATIVE INFRARED SPECTRA OF PEEKRELATED MATERIALAutian, J., “Toxicological Evaluation of Biomaterials: Primary AcuteToxicity Screening Program,” Journal of Artificial Organs, Vol 1, No.1, 1977, p. 53.Autian, J
39、., “The New Field of Plastic 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 Chem
40、istry,VolA4, No. 3, May 1970, 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:In Vitro Studies With In Vivo Correlation,” Journal of BiomedicalMaterials Research, Vol 12, 1978, p. 43.F2026 1
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42、re entirely their own responsibility.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 stand
43、ardsand should be addressed to ASTM 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 Commi
44、ttee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F2026 105
