ASTM F2848-2010 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns《医用级超高分子量聚乙烯纱线的标准规范》.pdf

《ASTM F2848-2010 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns《医用级超高分子量聚乙烯纱线的标准规范》.pdf》由会员分享，可在线阅读，更多相关《ASTM F2848-2010 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns《医用级超高分子量聚乙烯纱线的标准规范》.pdf（4页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F2848 10Standard Specification forMedical-Grade Ultra-High Molecular Weight PolyethyleneYarns1This standard is issued under the fixed designation F2848; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、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 ultra-high molecular weightpolyethylene (UHMWPE) yarns intended for use in medicaldevices or comp

3、onents of medical devices, such as sutures andligament fixations.1.2 This standard is intended to describe the requiredproperties and the procedures to be followed for testingUHMWPE yarns as raw materials for medical devices. Thisspecification does not purport to address the testing that isneeded fo

4、r medical devices or components of medical devicesthat are fabricated from the raw materials specified herein.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 The following precautionary caveat pertains only to thetest me

5、thod portion, Section 6, of this specification: Thisstandard does not purport to address all of the safety concerns,if any, associated with its use. It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory

6、limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2D792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD885 Test Methods for Tire Cords, Tire Cord Fabrics, andIndustrial Filament Yarns Made from ManufacturedOrganic-Base FibersD1907 Test

7、 Method for Linear Density of Yarn (YarnNumber) by the Skein MethodD2256 Test Method for Tensile Properties of Yarns by theSingle-Strand MethodF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF748 Practice for Selecting Generic Biologi

8、cal Test Meth-ods for Materials and Devices2.2 ISO Standards:3ISO 1628-3 PlasticsDetermination of the Viscosity ofPolymers in Dilute Solution Using CapillaryViscometersPart 3: Polyethylenes and PolypropylenesISO 2062 TextilesYarns from PackagesDeterminationof Single-end Breaking Force and Elongation

9、 at BreakISO 10993 Biological Evaluation of Medical Devices2.3 Other Documents:ICH Q3C(R3) International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceu-ticals for Human Use, Quality Guideline: Impurities:Residual Solvents43. Terminology3.1 Definitions of Terms Spe

10、cific to This Standard:3.2 UHMWPE filamentmolecularly oriented highly crys-talline fiber spun from virgin UHMWPE polymer powder.3.3 UHMWPE yarna continuous strand of more than oneUHMWPE filaments in a form suitable for operations such asweaving, knitting, etc., prior to packaging and sterilization.3

11、.4 linear densitymass per length, expressed in dtex(mass in grams per 10 000 metres).3.4.1 DiscussionTex is a unit of measure for the linearmass density of yarns and is defined as the mass in g/1000 m.Because of the low mass of yarns used in medical applications,decitex (abbreviated as dtex) is more

12、 commonly used, and is1This 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 June 1, 2010. Published July 2010. DOI: 10.1520/F284810.2For r

13、eferenced 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 standards Document Summary page onthe ASTM website.3Available from International Organization for Standardization (ISO

14、), 1, ch. dela Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.4Available from International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use (ICH), ICHSecretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 121

15、1 Geneva 20,Switzerland, http:/www.ich.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.mass in g/10 000 m. Another related unit of measure for thelinear mass density is denier, which is defined as g/9000 m.3.5 production liquidan

16、y liquid(s) used in the productionof the filaments and yarns, such as solvents and extractionsolutions.4. UHMWPE Filament and Yarn Requirements4.1 Compositional Requirements:4.1.1 Current yarns used for medical application with clini-cal history are produced with decalin as solvent. The maximumdecal

17、in residual level is 100 mg/kg (see 6.1).4.1.2 In case other production liquids are used, the accept-able residual levels of these particular production liquid(s)shall be reflective of toxicity, with a maximum acceptable limitconsistent with ICH Q3C(R3). If no ICH concentration guide-line has been e

18、stablished for a utilized production liquid, proofof biocompatibility has to be given.4.1.3 To promote consistency in production and pureness ofthe yarn, concentration limits for trace elements have beenestablished and are listed in Table 1.4.2 Physical Requirements:4.2.1 The density of the yarn sha

19、ll comply with the require-ment listed in Table 1.4.2.2 The linear density requirement of single filaments islisted in Table 1.4.2.3 The intrinsic viscosity requirement for the UHMWPEyarn is listed in Table 1.4.3 Mechanical Requirements:4.3.1 UHMWPE yarns shall meet the tensile requirementson streng

20、th, modulus and elongation-at-break as listed in Table1. Note that tensile properties of the final medical devicedepend on the construction of yarns used therein.4.4 Biocompatibility Requirements:4.4.1 The UHMWPE yarn shall be biocompatible. Whilethe biocompatibility of UHMWPE powder and fibers has

21、beencharacterized (1-8),5this data cannot be assumed to be appro-priate for all uses of UHMWPE. When new applications of thematerial, or modification to the material or physical forms ofthe materials are being contemplated, biological testing shallbe selected and conducted in accordance with Practic

22、e F748 orISO 10993, depending on the available published biocompat-ibility data and the end-use application.5. Sampling5.1 Compliance with this specification shall be determinedby sampling sizes and procedures as agreed upon between thepurchaser and seller.6. Test Methods6.1 Residual production liqu

23、ids shall be determined by gaschromatography or other suitable, validated analytical methodsfor the specific materials used to produce the yarn.6.2 Determine the trace element concentrations of titanium,sodium, chromium, iron, and calcium by a validated analyticalmethod, such as neutron activation a

24、nalysis (NAA), induc-tively coupled plasma spectroscopy (ICP), atomic absorption(AA), or X-ray fluorescence (XRF).6.3 Determine filament linear density by dividing the yarnlinear density, measured according to Test Method D1907,bythe number of filaments in the yarn.6.4 The intrinsic viscosity shall

25、be measured according toISO 1628-3, but in the case of incomplete dissolution of thepolymer, longer dissolution times and/or lower dissolutiontemperatures can be applied.6.5 Determine tensile strength, tensile modulus andelongation-at-break as the average of 15 samples tested accord-ing to the follo

26、wing test conditions, derived from Test MethodsD885, Test Method D2256, and ISO 2062, and optimized forUHMWPE yarns:6.5.1 Test Conditions:6.5.1.1 Temperature shall be 21 6 1C, at a relativehumidity between 40 and 75 %.6.5.1.2 Twisting level shall be according to product speci-fications, and any chan

27、ge in twist shall be avoided.6.5.1.3 Touching of the test specimen with bare hands shallbe avoided.6.5.1.4 Special care shall be taken to avoid slippage of theyarn in the clamps (see Appendix X2).6.5.1.5 A load cell with an accuracy of at least 61 % at theanticipated breaking force of the yarn shall

28、 be used.6.5.1.6 Gauge length shall be 500 mm.6.5.1.7 A pre-tension (in Newton) of 0.2 % of the yarnlinear density (in dtex) shall be applied at a speed of 50mm/min to remove any slack from the yarn. The initial yarnlength that is used in strain calculations, shall be adjustedaccordingly; that is, t

29、he value for the initial yarn length shall bethe actual initial yarn length after pre-tensioning.5The boldface numbers in parentheses refer to a list of references at the end ofthis standard.TABLE 1 Requirements for UHMWPE YarnsProperty Test Method RequirementTrace ElementsTitanium, mg/kg (Maximum)

30、6.2 25Sodium, mg/kg (Maximum) 6.2 50Chromium, mg/kg (Maximum) 6.2 10Iron, mg/kg (Maximum) 6.2 100Calcium, mg/kg (Maximum) 6.2 100Density, g/cm3Test Methods D792 0.950.98Filament Linear Density, dtex (Maximum) 6.3 2.7Intrinsic Viscosity, dl/g (Minimum) 6.4 12.5Tensile Strength, cN/dtex (Minimum) 6.5

31、28.0Tensile Modulus, cN/dtex (Minimum) 6.5 750Elongation-at-break, % 6.5 2.94.3F2848 1026.5.1.8 The extension rate shall be constant and half thegauge length per minute.6.5.1.9 Force and elongation shall be recorded until yarnbreakage.6.5.2 For tensile strength (in cN/dtex), divide the maximumforce-

32、at-break (in cN) by the yarn linear density (in dtex) asdetermined according to Test Method D1907.6.5.3 Tensile modulus (in cN/dtex) shall be determined asthe slope of the regression line to the part of the force-elongation curve corresponding to strains between 0.3 % and1.0 %, consisting of at leas

33、t 45 data points. The slope (in cN)shall be divided by yarn linear density (in dtex) as determinedby Test Method D1907.6.5.4 Elongation-at-break (in %) shall be determined bydividing the increase in length after pre-tensioning until break,by the initial yarn length, and multiplying with 100 %.7. Key

34、words7.1 fiber; high-modulus polyethylene (HMPE); high-performance polyethylene (HPPE); medical; surgical implants;ultra-high molecular weight polyethylene (UHMW-PE, UHM-WPE); yarnAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification is intended to describe the proper-ties require

35、d and procedures to be followed in testing medical-grade UHMWPE yarns. This is different from SpecificationF648, which addresses UHMWPE powder and bulk shapesfabricated from this powder for surgical implants.X1.2 While the biological response to medical-grade UH-MWPE in soft tissue and bone has been

36、 well characterized bya history of clinical use (1-3) and by laboratory studies (4-8),the data cannot necessarily be assumed to be applicable tomodified forms, including UHMWPE yarns, or applications ofthe material. The material user should carefully analyze thepublished biocompatibility data and th

37、en decide whether addi-tional testing may be necessary as a result of the changes whichmay have been made.X1.3 There is no evidence at this time that the concentra-tion of trace elements has any effect on the physical propertiesor the biological response of UHMWPE fabricated forms.Limits for trace e

38、lement concentrations in this standard arebased on experience with current medical-grade UHMWPEyarns.X1.4 The relationship between these mechanical propertiesand the in-vivo performance of a fabricated form has not beendetermined. While trends are apparent, specific property-polymer structure relati

39、onships are not well understood. Thesemechanical tests are frequently used to evaluate the reproduc-ibility of a fabrication procedure and are applicable as qualitycontrol tests to determine lot-to-lot repeatability for a processof converting virgin polymer powder into a fabricated form.The mechanic

40、al properties are subject to variation as thefabrication process variables (such as temperature, pressureand time) are changed.X1.5 All properties are based on non-sterilized material,because this standard describes a raw material. The recom-mended method of sterilization is ethylene oxide steriliza

41、tion.High-energy sterilization methods such as, for example,gamma-irradiation or e-beam irradiation are not advised sincethey may result in a loss of properties.X2. SUGGESTED GUIDELINE FOR CLAMPING IN TENSILE TESTINGX2.1 This guideline is intended to minimize slip of the yarnin the clamps during ten

42、sile testing. It is recommended to usepneumatic yarn grips from the Instron type CP103684 withInstron 1498K stainless steel faces, especially designed toovercome the problem of sample failure by incorporating alever design which evenly distributes the gripping force overthe surface.F2848 103REFERENC

43、ES(1) Charnley, J., Cupiz, A., “The Nine and Ten Year Results of the LowFriction Arthroplasty of the Hip,” Clinical Orthopaedics, Vol 95, No.9, 1973.(2) Cimbrelo, E. G., Munera, L., “Early and Late Loosening of theAcetabular Cup After Low-Friction Arthroplasty”, The Journal ofBone and Joint Surgery,

44、 Vol 74-A, No. 8, 1992.(3) Mirra, J., Amstutz, H., Matos, M., Gold, R., “The Pathology of theJoint Tissues and Its Clinical Relevance in Prosthesis Failure,”Clinical Orthopaedics, No. 117, 1976.(4) Turner, J., Lawrence, W., Autian, J., “Subacute Toxicity Testing ofBiomaterials Using Histopathologic

45、Evaluation of Rabbit MuscleTissue,” Journal of Biomedical Materials Research, Vol 7, 1973.(5) Laing, P., “Compatibility of Biomaterials,” Orthopedic Clinics ofNorth America, Vol 4, No. 2, 1973.(6) Escalas, F., Galante, J., Rostoker, W., “Biocompatibility of Materialsfor Total Joint Replacement,” Jou

46、rnal of Biomedical Materials Re-search, Vol 10, No. 2, 1976.(7) Traor, A. S., Guidoin, M. F., Marois, Y., Zhang, Z., Douville, Y.,Guidoin, R., King, M. W., Legrand, A. P., “Newly developed hybridsuture with lubricant: noninvasive in vivo assessment of biocompat-ibility with multiparametric MR imagin

47、g,” Journal of InvestigativeSurgery, Vol 20, No. 2, 2007.(8) Kurtz, S. M., The UHMWPE Biomaterials Handbook: Ultra-HighMolecular Weight Polyethylene in Total Joint Replacement and Medi-cal Devices (2nd edition). Burlington, MA: Academic Press, 2009.ASTM International takes no position respecting the

48、 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 responsibility.This standard is

49、 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 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 Committee on Standards, at the