ASTM F2026-2008 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications《外科植入物用聚醚醚酮(PEEK)聚合物的标准规范》.pdf

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1、Designation: F 2026 08Standard Specification forPolyetheretherketone (PEEK) Polymers for Surgical ImplantApplications1This standard is issued under the fixed designation F 2026; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear 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,p

3、owder, and so forth). It provides requirements and associatedtest methods for these thermoplastics when they are to be usedin the manufacture of intracorporeal devices such as surgicalimplants or components of surgical or dental devices.1.2 As with any material, some characteristics may bealtered by

4、 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 these polymers should be evaluatedusing test methods which are appropriate to ensure safety andeffic

5、acy 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 injection molded forms. Fabricated forms, material orforms containing colorants, fillers, processing aids, or

6、otheradditives, as well as polymer blends which contain PEEK, orreclaimed materials, are not covered 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 virginP

7、EEK polymers 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 When evaluating material in accordance with this speci-fication, hazardous materials, operations, and equipment maybe involved.

8、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 safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Docum

9、ents2.1 ASTM Standards:2D 149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD 256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD 570 Test Method for Water Absorption of Plastics

10、D 638 Test Method for Tensile Properties of PlasticsD 648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise PositionD 695 Test Method for Compressive Properties of RigidPlasticsD 696 Test Method for Coefficient of Linear Thermal Ex-pansion of Plastics Between 30C

11、and 30C with aVitreous Silica DilatometerD 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsD 792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD 955 Test Method of Measuring Shrinkage fr

12、om MoldDimensions of ThermoplasticsD 1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD 1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD 1898 Practice for Sampling of Plastics3D 3417 Test Method for Enthalpies of Fusion and Crystal-lization of

13、Polymers by Differential Scanning Calorimetry(DSC)3D 3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning Calorimetry1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devi

14、ces and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Aug. 1, 2008. Published September 2008. Originallyapproved in 2000. Last previous edition approved in 2007 as F 2026 07a.2For referenced ASTM standards, visit the ASTM website, www.astm.org, or

15、contact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.D 4000

16、Classification System for Specifying Plastic Mate-rialsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 ISO Standards:ISO 1628/1 PlasticsGuidelines for the Standardization ofMethods for Determination of Viscosity Number andLimiting Viscosity Number of Polyme

17、rs in DiluteSolutionPart 1: General Conditions4ISO 1133 PlasticsDetermination of the Melt Mass-FlowRate (MFR) and the Melt Volume-Flow Rate (MVR) ofThermoplastics4ISO 10993 Biological Evaluation of Medical Devices, Parts1-1242.3 Other Documents:United States Pharmacopeia, Vol. XXI, or latest edition

18、53. 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 by means of machining, extruding, and compressionmolding virgin forms into a subsequent entity (for example,fiber

19、s, tubes, rods, slabs, sheets, film, or complex shaped partsand devices).3.1.2 formulated compound, nthe PEEK materials, parts,or devices fabricated from virgin forms in such a way as tocontain intentional or unintentional adjuvant substances.3.1.3 virgin forms, nthat form of the PEEK polymer asobta

20、ined by the synthesizer. It typically will be in the form ofpellets or powder. It is the material from which fibers, tubes,rods, slabs, sheets, films, or specific parts and devices arefabricated.4. Classification4.1 The PEEK polymer in the scope of this specification isa pure semicrystalline homopol

21、ymer 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 Types of PEEK plastics, molding, and extrusion gradesare described in Classification System D 4000.5.

22、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 infrared spectrum, which exhibits major bands only at thewavelengths listed for a standard reference spect

23、rum 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 degreeof material purity.5.1.2 The presence of additional bands in the samplesinfrared spectrum comp

24、ared 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 additional characteristicsare necessary because of a specific application, the proceduresreferenced in 5.6 ar

25、e recommended, or as agreed upon betweenthe vendor and the purchaser.5.3 The viscosity requirements will vary depending uponthe grade and test method. The method and requirements shallbe agreed upon between the vendor and the purchaser.5.4 The chemical, physical, and mechanical properties offabricat

26、ed 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 particular device to perform properly will varyfrom one device type to another. Table 2 lists some typicalproper

27、ties 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 represent the material charac-teristics of the non-sterilized finished part.5.6 Tests and test procedures

28、 shall be such as to ensure ahigh level of control and characterization of the virgin polymeras received from the supplier. The following are some testmethods that may be appropriate: Test Method D 149, TestMethod D 256, Test Method D 570, Test Method D 638, TestMethod D 648, Test Method D 695, Test

29、 method D 696, TestMethods D 790, Test Methods D 792, Test Method D 955, TestMethod D 1238, Test Method D 1505, Test Method D 3417,Test Method D 3418, and Classification System D 4000.6. Sampling6.1 The material should be sampled in accordance with thestandard sampling procedures, such as those desc

30、ribed inPractice D 1898, or other sampling techniques unless otherwiseagreed upon between the consumer and the supplier.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from U.S. Pharmacopeia (USP), 12601 Twinbr

31、ook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.6Silverstein, 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 The PEEK polymers may be processed by mostt

32、echniques 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 weaken parts fabricated of any plastic mate-rial

33、. 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. Therefore, it is imperative that the manu-f

34、acturer 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 crys-tallinity is an important characteristic of these materials.Performance characteristics are related to the percent crys

35、tal-linity. Certain additives and processes (for example, excessivecross linking) can limit these materials ability to crystallize.Therefore, this feature of the polymer and its fabricated formshould be evaluated, using appropriate test methods, to ensureefficacy.X1.3 A formulated compound or fabric

36、ated 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 inaccordance with Practice F 748 or the ISO 10

37、993 series.X2. CHEMICAL STRUCTURE OF PEEK7Kurtz, S.M. and Devine, J.N., “PEEK Biomaterials in Trauma, Orthopedic, andSpinal Implants,” Biomaterials, Vol 28, No. 32, 2007, pp. 4845-4869.TABLE 2 Typical Properties of Fabricated FormsParameter ISO Methods and Requirements ASTM Methods and RequirementsD

38、ensity, kg/m3ISO 1183 1280 - 1320 ASTM D 1505 1280 - 1320Tensile Strengthat Yield (Zero Slope), min, MPaat Break, min, MPAISO 527, Type 1B,50 mm/min 9070ASTM D 638,Type IV, 5.08 cm/min 9070Percent elongation at break,min, %ISO 527, Type 1B,50 mm/min5 ASTM D 638,Type IV, 5.08 cm/min5Flexural Strength

39、, min, MPa ISO 178 110 ASTM D 790 110Flexural Modulus, min, GPa ISO 178 3 ASTM D 790 3Impact Strength, Notched Izod,minISO 180 4(kJ/m2)ASTM D 256,0.254 cm depth, 0.025 cm radius50(J/m)F2026083X3. REPRESENTATIVE INFRARED SPECTRA OF PEEKRELATED MATERIALAutian, J., “Toxicological Evaluation of Biomater

40、ials: Primary AcuteToxicity Screening Program,” Journal of Artificial Organs, Vol 1, No.1, 1977, p. 53.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 Est

41、rella, M. E., “Rapid In Vitro Screening of Polymers forBiocompatibility,” Journal of Macromolecular Science 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:

42、In Vitro Studies With In Vivo Correlation,” Journal of BiomedicalMaterials Research, Vol 12, 1978, p. 43.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that

43、 determination of the validity of any such patent rights, and the riskof infringement of such rights, are 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 reapprov

44、ed or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand 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 fee

45、l that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee 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).F2026084