1、Designation: F2026 14Standard 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 The properties included in this specificat
4、ion are thoseapplicable for PEEK polymers only. Indicated properties arefor fabricated forms. Materials or forms containing colorants,fillers, processing aids, or other additives, as well as polymerblends which contain PEEK, or reclaimed materials, are notcovered by this specification.1.3 This speci
5、fication is designed to recommend physical,chemical, and biological test methods to establish a reasonablelevel of confidence concerning the performance of virginPEEK polymers for use in medical implant devices.1.4 The values stated in SI units are to be regarded asstandard. No other units of measur
6、ement are included in thisstandard.1.5 When evaluating material in accordance with thisspecification, hazardous materials, operations, and equipmentmay be involved. This standard does not purport to address allof the safety concerns, if any, associated with its use. It is theresponsibility of the us
7、er of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD638 Test Method for Tensile Pr
8、operties of PlasticsD648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise PositionD695 Test Method for Compressive Properties of RigidPlasticsD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD792
9、 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning Cal
10、orimetryD4000 Classification System for Specifying Plastic Materi-alsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standards:3ISO 178 PlasticsDetermination of Flexural PropertiesISO 180 PlasticsDetermination of Izod Impact StrengthISO 527 PlasticsDetermi
11、nation of Tensile PropertiesPart 1: General PrinciplesISO 1183 PlasticsMethods for Determining the Density ofNon-cellular PlasticsPart 2: Density Gradient ColumnMethodISO 10993 Biological Evaluation of Medical Devices, Parts1-12ISO 13485 Medical DevicesQuality ManagementSystemsRequirements for Regul
12、atory Purposes2.3 Other Documents:United States Pharmacopeia, Vol. XXI, or latest edition43. Terminology3.1 Definitions of Terms Specific to This Standard:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility
13、 ofSubcommittee F04.11 on Polymeric Materials.Current edition approved March 1, 2014. Published May 2014. Originallyapproved in 2000. Last previous edition approved in 2012 as F2026 12. DOI:10.1520/F2026-14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer
14、 Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from U.S. Pharma
15、copeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.1 fabricated forms, nthose items into which the virginforms may be converted. These include shapes and
16、 formsproduced 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
17、as to containintentional or unintentional adjuvant substances.3.1.3 virgin forms, nthe initially delivered form of thepolymer as synthesized from its monomers prior to anyprocessing or fabrication into a medical device. The providedresin is typically in the form of pellets, granules, or powder andis
18、 the material from 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 isa pure semicrystalline homopolymer consisting of phenylenerings connected by ether (E) and carbonyl (or ketone, K
19、)groups along the polymer chain (see Appendix X1). Itspolymeric structure is defined by the repeating unit EEK.4.2 Types of PEEK plastics, molding, and extrusion gradesare described in Classification System D4000.5. Properties5.1 The properties listed below shall be considered inselecting material(s
20、) in accordance with the specific end-userequirements.5.2 The infrared spectrum5of these materials is character-istic of their molecular repeating units. A representative spec-trum is listed in Appendix X3. The PEEK polymer shall yieldan infrared spectrum, which exhibits major bands only at thewavel
21、engths listed for a standard reference spectrum of thatmaterial.5.2.1 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 degreeof material purity.5.2.2 The presence of additiona
22、l bands in the samplesinfrared spectrum compared to that of the reference materialmay indicate a different PAEK or impurities, or both.5.3 The physical and chemical property requirements for thevirgin polymer are listed in Table 1. If additional characteristicsare necessary because of a specific app
23、lication, the proceduresreferenced in Section 2 are recommended, or as agreed uponbetween the vendor and the purchaser.5.4 The viscosity requirements will vary depending uponthe grade and test method. The method and requirements shallbe agreed upon between the vendor and the purchaser.5.5 The chemic
24、al, physical, and mechanical properties offabricated forms are related to the processes utilized inproducing the fabricated form (for example, molding,machining, sterilization, and so forth). Additionally, the prop-erties necessary for a particular device to perform properly willvary from one device
25、 type to another. Table 2 lists some typicalproperties of non-sterilized fabricated forms.5.6 Test specimens shall be fabricated (machined, injectionmolded, and so forth) from the virgin polymer, or finished part,in such a way as to effectively represent the material charac-teristics of the non-ster
26、ilized finished part.5.6.1 As with any material, some characteristics may bealtered by the processing techniques (for example, molding,extrusion, machining, assembly, and sterilization) required forthe production of a specific part or device. Therefore, proper-ties of fabricated forms of these polym
27、ers should be evaluatedusing test methods which are appropriate to ensure safety andefficacy as agreed upon by the vendor, purchaser, and regulat-ing bodies.5.7 Tests and test procedures shall be such as to ensure ahigh level of control and characterization of the virgin polymeras received from the
28、supplier. The test methods referenced inSection 2 may be appropriate (Test Methods D648 and D695).5Silverstein, R. M., Bassler, G. C., and Morrill, T. C., Spectroscopic Identifica-tion of Organic Compounds, 5th ed., John Wiley polyetheretherketoneAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1
29、 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 successfullyused include steam, ethylene oxide, and irradiation. Repeatedsterilization may weak
30、en 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 the polymer anddesign, fabrication, intended function, and method of steriliza-tion of the device.
31、 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 significant level of crystal-linity is an important characteristic of these materials. Perfor-mance c
32、haracteristics are related to the percent crystallinity.Certain additives and processes (for example, excessive crosslinking) can limit these materials ability to crystallize.6Hay, J. N., and Kemmish, D. J., “Environmental Stress Crack Resistance andAbsorption of Low-Molecular-Weight Penetrants by P
33、oly(Aryl Ether EtherKetone),” Polymer, Vol 29, April 1988, pp. 613618.7Srivastava, A. P., Depke, N., and Wolf, C. J., “Environmental Stress Deforma-tion of Poly(ether ether ketone),” J. Applied Polymer Science, Vol 66, 1997, pp.725731.8Kurtz, S.M. and Devine, J.N., “PEEK Biomaterials in Trauma, Orth
34、opedic, andSpinal 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/m3ISO 1183 1280 - 1320 ASTM D792 orASTM D15051280 - 1320Tensile Strength: ISO 527, Type 1B,50
35、mm/minASTM D638,Type IV, 5.08 cm/minat yield (zero slope), min, MPa 90 90at break, min, MPa 70 70Elongation at break,Amin, % 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, min, GPa ISO 178 3 ASTM D790 3Impact strength
36、,notched Izod, minISO 180 4 (kJ/m2) ASTM D256, 0.254 cm depth,0.025 cm radius50 (J/m)AUse an extensometer for measuring strain and calculating percent elongation.F2026 143Therefore, this feature of the polymer and its fabricated formshould be evaluated, using appropriate test methods, to ensureeffic
37、acy.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 adjuvant substances, and subsequent formu-lated compounds, parts, and devices shall be established inacco
38、rdance with Practice F748 or the ISO 10993 series.X2. CHEMICAL STRUCTURE OF PEEKX3. REPRESENTATIVE INFRARED SPECTRA OF PEEKF2026 144RELATED MATERIALAutian, J., “Toxicological Evaluation of Biomaterials: Primary AcuteToxicity Screening Program,” Journal of Artificial Organs, Vol 1, No.1, 1977, p. 53.
39、Autian, J., “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 Sci
40、ence Chemistry,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. 4
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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 145
