Designation:F2026−14
Standard Specification for
Polyetheretherketone(PEEK)Polymers for Surgical Implant Applications1
This standard is issued under thefixed designation F2026;the number immediately following the designation indicates the year of original adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.A superscript epsilon(´)indicates an editorial change since the last revision or reapproval.
1.Scope
1.1This specification covers polyetheretherketone(PEEK) polymer in virgin forms as supplied by a vendor(pellets, powder,fabricated forms,and so forth).It provides require-ments 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.
1.2The 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.
1.3This 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.
1.4The values stated in SI units are to be regarded as standard.No other units of measurement are included in this standard.
1.5When 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 appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.
2.Referenced Documents
2.1ASTM Standards:2
D256Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D638Test Method for Tensile Properties of Plastics
D648Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D695Test Method for Compressive Properties of Rigid Plastics
D790Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materi-als
D792Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by Displacement
D1505Test Method for Density of Plastics by the Density-Gradient Technique
D3418Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D4000Classification System for Specifying Plastic Materi-als
F748Practice for Selecting Generic Biological Test Methods for Materials and Devices
2.2ISO Standards:3
ISO178Plastics—Determination of Flexural Properties ISO180Plastics—Determination of Izod Impact Strength ISO527Plastics—Determination of Tensile Properties—Part1:General Principles
ISO1183Plastics—Methods for Determining the Density of Non-cellular Plastics—Part2:Density Gradient Column Method
ISO10993Biological Evaluation of Medical Devices,Parts 1-12
ISO13485Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
2.3Other Documents:
United States Pharmacopeia,V ol.XXI,or latest edition4 3.Terminology
3.1Definitions of Terms Specific to This Standard:
1This specification is under the jurisdiction of ASTM Committee F04on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.11on Polymeric Materials.
Current edition approved March1,2014.Published May2014.Originally approved in2000.Last previous edition approved in2012as F2026–12.DOI: 10.1520/F2026-14.
2For referenced ASTM standards,visit the ASTM website,,or contact ASTM Customer Service at For Annual Book of ASTM Standards volume information,refer to the standard’s Document Summary page on the ASTM website.
3Available from American National Standards Institute(ANSI),25W.43rd St., 4th Floor,New York,NY10036,
4Available from U.S.Pharmacopeia(USP),12601Twinbrook Pkwy.,Rockville, MD20852-1790,
Copyright©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959.United States
3.1.1fabricated forms,n—those items into which the virgin forms may be converted.These include shapes and forms produced by 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 and devices).
3.1.2formulated compound,n—materials,parts,or devices fabricated from virgin forms in such a way as to contain intentional or unintentional adjuvant substances.
3.1.3virgin forms,n—the initially delivered form of the polymer as synthesized from its monomers prior to any processing or fabrication into a medical device.The provided resin is typically in the form of pellets,granules,or powder and is the material from whichfibers,tubes,rods,slabs,sheets,films,or specific parts and devices are fabricated.
4.Classification
4.1The 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(see Appendix X1).Its polymeric structure is defined by the repeating unit EEK. 4.2Types of PEEK plastics,molding,and extrusion grades are described in Classification System D4000.
5.Properties
5.1The properties listed below shall be considered in selecting material(s)in accordance with the specific end-use requirements.editor evaluating revision
5.2The 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 yield an infrared spectrum,which exhibits major bands only at the wavelengths listed for a standard reference spectrum of that material.
5.2.1The infrared spectrum,as used in this specification,is to identify the specific type of poly aryl ether ketone(PAEK) present and does not necessarily indicate an acceptable degree of material purity.
5.2.2The presence of additional bands in the sample’s infrared spectrum compared to that of the reference material may indicate a different PAEK or impurities,or both.
5.3The physical and chemical property requirements for the virgin polymer are listed in Table1.If additional characteristics are necessary because of a specific application,the procedures referenced in Section2are recommended,or as agreed upon between the vendor and the purchaser.
5.4The viscosity requirements will vary depending upon the grade and test method.The method and requirements shall be agreed upon between the vendor and the purchaser.
5.5The chemical,physical,and mechanical properties of fabricated forms are related to the processes utilized in producing the fabricated form(for example,molding, machining,sterilization,and so forth).Additionally,the prop-erties necessary for a particular device to perform properly will vary from one device type to another.Table2lists some typical properties of non-sterilized fabricated forms.
5.6Test specimens shall be fabricated(machined,injection molded,and so forth)from the virgin polymer,orfinished part, in such a way as to effectively represent the material charac-teristics of the non-sterilizedfinished part.
5.6.1As with any material,some characteristics may be altered by the processing techniques(for example,molding, extrusion,machining,assembly,and sterilization)required for the production of a specific part or device.Therefore,proper-ties of fabricated forms of these polymers should be evaluated
using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor,purchaser,and regulat-ing bodies.
5.7Tests and test procedures shall be such as to ensure a high level of control and characterization of the virgin polymer as received from the supplier.The test methods referenced in Section2may be appropriate(Test Methods D648and D695).
5Silverstein,R.M.,Bassler,G.C.,and Morrill,T.C.,Spectroscopic Identifica-
tion of Organic Compounds,5th ed.,John Wiley&Sons,New York,NY.
TABLE1Required Properties of Virgin Resin
Parameter Method Requirement
Glass transition temperature,T g(°C)DSC,A20°K/min,sealed sample,T g taken
on second reheat,D3418
125-165
Melt temperature,
T m(°C)DSC,20°K/min,sealed sample,T m taken
as max point on reheat endotherm,
D3418
320-360
Recrystallization temperature,T c(°C)DSC,20°K/min,sealed sample,T c taken
as max point on cooling exotherm,D3418
260-320
Viscosity As agreed per5.4As agreed per5.4 Infrared spectrum As agreed per5.2As agreed per5.2
Total heavy metals as lead,max,%US Pharmacopeia,
Test231
<0.1
A Differential Scanning Calorimetry
(DSC).
5.7.1With reduced crystallinity,certain polymers have been shown to be more susceptible to environmental stress cracking.6,7Depending upon the implant application,the end user should evaluate the material for environmental stress cracking resistance.6,7
6.Sampling
6.1The material should be sampled in accordance with standard sampling procedures or other sampling techniques unless otherwise agreed upon between the consumer and the supplier.
7.General Requirements
7.1Quality System Requirements—The PEEK polymer and fabricated forms as described in the scope of this specification should be produced in accordance with an ISO13485-certified quality management system.
7.2Biocompatibility—PEEK has been shown to produce a well-characterized level of biological response following long term clinical use.8The results of these studies and the clinical history indicate an acceptable level of biological response in the applications in which the material has been utilized.8When new applications,or modification to the material or physical forms of the materials are being contemplated,biocompatibil-ity shall be determined in accordance with Practice F748or the ISO10993series,unless otherwise agreed upon between the packager and the consumer and regulating bodies.A recent review article8includes an extensive bibliography regarding the biocompatibility of PEEK biomaterials.
8.Keywords
8.1PEEK;polyetheretherketone
APPENDIXES (Nonmandatory Information) X1.RATIONALE
X1.1The PEEK polymers may be processed by most techniques available for thermoplastic polymers.Medical de-vices and components 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 mate-rial.The number of times a given part may be sterilized safely without fear of subsequent failure depends on a number of factors including the molecular weight of the polymer and design,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 maximum number of sterilization cycles to which it can be safely subjected.
X1.2The potential to develop a significant level of crystal-linity is an important characteristic of these materials.Perfor-mance characteristics are related to the percent crystallinity. Certain additives and processes(for example,excessive cross linking)can limit these materials’ability to crystallize.
6Hay,J.N.,and Kemmish,D.J.,“Environmental Stress Crack Resistance and Absorption of Low-Molecular-Weight Penetrants by Poly(Aryl Ether Ether Ketone),”Polymer,V ol29,April1988,pp.613–618.
7Srivastava,A.P.,Depke,N.,and Wolf,C.J.,“Environmental Stress Deforma-
tion of Poly(ether ether ketone),”J.Applied Polymer Science,V ol66,1997,pp. 725–731.
8Kurtz,S.M.and Devine,J.N.,“PEEK Biomaterials in Trauma,Orthopedic,and Spinal Implants,”Biomaterials,V ol28,No.32,2007,pp.4845-4869.
TABLE2Required Properties of Fabricated Forms
Parameter ISO Methods and Requirements ASTM Methods and Requirements
Density,kg/m3ISO11831280-1320ASTM D792or
ASTM D1505
1280-1320
Tensile Strength:ISO527,Type1B,
50mm/min
ASTM D638, Type IV,5.08cm/min
at yield(zero slope),min,MPa9090 at break,min,MPa7070
Elongation at break,A min,%ISO527,Type1B,
50mm/min 5ASTM D638,
Type IV,5.08cm/min
5
Flexural strength,min,MPa ISO178110ASTM D790110 Flexural modulus,min,GPa ISO1783ASTM D7903
Impact strength, notched Izod,min ISO1804(kJ/m2)ASTM D256,0.254cm depth,
0.025cm radius
50(J/m)
A Use an extensometer for measuring strain and calculating percent
elongation.
Therefore,this feature of the polymer and its fabricated form should be evaluated,using appropriate test methods,to ensure efficacy.
X1.3A formulated compound or fabricated part or device may contain optional adjuvant substances required for the
fabrication 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 in accordance with Practice F748or the ISO 10993series.
X2.CHEMICAL STRUCTURE OF
PEEK
X3.REPRESENTATIVE INFRARED SPECTRA OF
PEEK
RELATED MATERIAL
Autian,J.,“Toxicological Evaluation of Biomaterials:Primary Acute Toxicity Screening Program,”Journal of Artificial Organs,V ol1,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.,O’Brannon,W.,Thompson,S.H.,Hodge, R.,and Estrella,M.E.,“Rapid In Vitro Screening of Polymers for
Biocompatibility,”Journal of Macromolecular Science Chemistry,V ol A4,No.3,May1970,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 Biomedical Materials Research,V ol12,1978,p.43.
ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard.Users of this standard are expressly advised that determination of the validity of any such patent rights,and the risk of 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 everyfive years and if not revised,either reapproved or withdrawn.Your comments are invited
either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.Your comments will receive careful consideration at a meeting of the responsible technical committee,which you may attend.If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards,at the address shown below.
This standard is copyrighted by ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959, United States.Individual reprints(single or multiple copies)of this standard may be obtained by contacting ASTM at the above address or at610-832-9585(phone),610-832-9555(fax),or (e-mail);or through the ASTM website ().Permission rights to photocopy the standard may also be secured from the ASTM website(/
COPYRIGHT/).

版权声明：本站内容均来自互联网，仅供演示用，请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系QQ:729038198，我们将在24小时内删除。