ASTM_F_2848_-_10.pdf

Designation:F284810Standard 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 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 components 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 for 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 method 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 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 Method for Linear Density of Yarn(Yarn Num-ber)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 Biological Test Methodsfor Materials and Devices2.2 ISO Standards:3ISO 1628-3 PlasticsDetermination of the Viscosity ofPolymersinDiluteSolutionUsingCapillaryViscometersPart 3:Polyethylenes and PolypropylenesISO 2062 TextilesYarns from PackagesDeterminationof Single-end Breaking Force and Elongation 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 Specific to This Standard:3.1.1 UHMWPE filamentmolecularly oriented highlycrystalline fiber spun from virgin UHMWPE polymer powder.3.1.2 UHMWPE yarna continuous strand of more thanone UHMWPE filaments in a form suitable for operations suchas weaving,knitting,etc.,prior to packaging and sterilization.3.1.3 linear densitymass per length,expressed in dtex(mass in grams per 10 000 metres).3.1.3.1 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 commonly used,and ismass in g/10 000 m.Another related unit of measure for thelinear mass density is denier,which is defined as g/9000 m.1This 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 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 standards Document Summary page onthe ASTM website.3Available from International Organization for Standardization(ISO),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 195,1211 Geneva 20,Switzerland,http:/www.ich.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.4 production liquidany liquid(s)used in the produc-tion of 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 maximumdecalin 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 concentrati