ASTM F2848-17 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns.pdf

1、Designation: F2848 17Standard 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. This specification covers natural (non-colored) and pigmented (colored) yarns.1.2 This standard is intended to describe the requirementsand the procedures to be followed for testing UHMWPE yarnsas a component for medical devices prior

4、 to manufacturingprocesses of the medical device such as fabric formation,assembling and sterilization. This specification does not pur-port to address the requirements for the finished medicaldevices or the testing that is needed for medical devices that arefabricated from the components specified

5、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 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establi

6、sh appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment

7、 of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD885/D885M Test Meth

8、ods for Tire Cords, Tire CordFabrics, and Industrial Filament Yarns Made from Manu-factured Organic-Base FibersD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1601 Test Method for Dilute Solution Viscosity of Ethyl-ene PolymersD1907/D1907M Test Method for Linear Density o

9、f Yarn(Yarn Number) by the Skein MethodD2256/D2256M Test Method for Tensile Properties of Yarnsby the Single-Strand MethodF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF756 Practice for Assessment of Hemolytic Properties ofMaterialsF2625 Test Method for Measurem

10、ent of Enthalpy of Fusion,Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of DifferentialScanning Calorimetry2.2 ISO Standards:3ISO 1628-3 PlasticsDetermination of the Viscosity ofPolymers in Dilute Solution Using CapillaryViscometersPart 3: Polyethylene

11、s and PolypropylenesISO 2062 TextilesYarns from PackagesDeterminationof Single-end Breaking Force and Elongation at BreakISO 10993-1 Biological Evaluation of Medical Devices Part1 Evaluation and testing within a risk managementprocesssISO 10993-4 Biological Evaluation of Medical Devices Part4 Select

12、ion of tests for interactions with bloodISO 10993-5 Biological Evaluation of Medical Devices Part5 Tests for in vitro cytotoxicityISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitizationISO 10993-17 Biological Evaluation of Medical DevicesPart 17 Est

13、ablishment for allowable limits for leachablesubstances1This 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 May 1, 2017. Published July 2

14、017. Originally approvedin 2010. Last previous edition approved in 2016 as F284816. DOI: 10.1520/F284817.2For 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 standar

15、ds 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-

16、2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technica

17、l Barriers to Trade (TBT) Committee.1ISO 8 Biological Evaluation of Medical Devices Part 18 Chemical characterization of materialsISO 13485 Medical Devices Quality Management Sys-tems Requirements for regulatory purposesISO 14971 Medical Devices Application of risk manage-ment to Medical Devices2.3

18、Other Documents:ICH Q3C(R3) International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceu-ticals for Human Use, Quality Guideline: Impurities:Residual Solvents4US Code of Federal RegulationsCFR section 21 Parts 70,71, 73, 74 and 80 on color additives for medical de

19、vices53. 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, knit

20、ting, etc.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 a

21、s 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.3.1.4 production liquidany liquid(s) used in the produc-tion of the filaments and yarns, such as solvents and extractionsolutions.4. UHMWPE Fila

22、ment and Yarn Requirements4.1 Compositional Requirements:4.1.1 Maximum acceptable limits for residual constituentsshall be determined based on prevention of adverse effectswhen used in a medical application (see also 4.4). Residualconstituents can be residues from the used production liquids,process

23、ing aids, or residual elements from raw materials.4.1.2 Residual production liquids shall be assessed withregard to toxicity hazards, with a maximum acceptable limitconsistent with ICH Q3C(R3). If no ICH concentration guide-line has been established for a utilized production liquid, atoxicity assess

24、ment and corresponding potential leaching char-acteristics for the identified potential toxic ingredients shouldbe performed in accordance with 4.4 to establish a maximumresidual level.4.1.3 Potential effects of residual production liquid(s) onmechanical or physical yarn properties should be conside

25、red aswell for establishing maximum limits.4.1.4 For decalin as solvent, the residual level has beenestablished in accordance with 4.4 and 4.1.3 and shall be lessthan 100 mg/kg (see 6.1).4.1.5 In case a color additive or pigment is added to theyarn, this should be compliant to the FDA regulation asp

26、ublished in the US Code of Federal Regulations - CFR section21, parts 70, 71, 73, 74 and 80 on color additives for medicaldevices.4.2 Physical Requirements:4.2.1 The density of the yarn shall comply with the require-ment listed in Table 1.4.2.2 The linear density requirement of single filaments isli

27、sted 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 Tensile testing shall be conducted after sufficientconditioning to the laboratory conditions, with a minimum of 2h to achieve uniform temperatures within the yarn packa

28、ge.4.3.2 UHMWPE yarns shall meet the tensile requirementson strength, modulus, and elongation-at-break as listed forindividual data as listed in Table 1. Note that tensile propertiesof the final medical device depend on the construction of yarnsused therein.4.4 Biocompatibility and Biosafety Risk As

29、sessment Re-quirements:4.4.1 The first principle of ISO 10993-1 states that biologi-cal evaluation of any material or medical device intended foruse in humans shall form part of a structured biologicalevaluation program within a risk management process inaccordance with ISO 14971. This should be add

30、ressed throughchemical characterization of the material, following ISO4Available 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,

31、http:/www.ich.org.5U.S. Government Publishing Office, 710 North Capitol Street N.W.,Washington, DC (corner of North Capitol and H Streets), www.gpo.gov/about/bookstore.htmTABLE 1 Requirements for UHMWPE YarnsProperty Test Method RequirementDensity, g/cm3Test Methods D792 or D1505 0.95 - 1.00Melting

32、temperature peak, C Test Method F2625 140 - 150Filament Linear Density, dtex (Maximum) 6.3 2.7Intrinsic Viscosity, dl/g (Minimum) 6.4 15Tensile Strength, cN/dtex (Minimum) 6.5 26Tensile Modulus, cN/dtex (Minimum) 6.5 750Elongation-at-break, % 6.5 2-5Additional requirement for colored yarn:Pigment co

33、ntent, wt.% (Maximum)Chromium-cobalt-aluminum oxide6.2 2F2848 17210993-18, and toxicological assessment based on ISO 10993-17. See the following for more specific specifications for thismedical-grade UHMWPE yarn:4.4.1.1 The full quantitative composition of the yarn ascomponent supplied should be est

34、ablished, including residualprocessing aids and relevant impurities or trace elements;hereinafter referred to as ingredients.4.4.1.2 For each ingredient, a toxicological assessmentshould be performed based on ISO 10993-17, which meansthat Tolerable Intake (TI) values in mg/kg bw/day are derivedbased

35、 on collected information on known critical adverseeffects.4.4.1.3 A worst-case assessment should be performed foreach ingredient. Determine whether the quantity established in4.4.1.1 is below the TI as defined in 4.4.1.2 for the applicationunder consideration or, if the application is unknown, for

36、1 g ofyarn (see Appendix X1.3), assuming a body weight of 70 kgand full bioavailability of the ingredients within 1 day. The 70kg body weight is not appropriate for pediatric and/or neonateapplications. A lower body weight is required for calculationsfor these applications.4.4.1.4 If the worst-case

37、assessment indicates that the TI canbe exceeded, perform extraction and/or leaching studies inaccordance with ISO 1099318 and determine whether theextracted/leached amount is below the TI for the applicationunder consideration or, if the application is unknown, for 1 g ofyarn assuming a body weight

38、of 70 kg and bioavailability ofthe extracted components/leachables within 1 day. The 70 kgbody weight is not appropriate for pediatric and/or neonateapplications. A lower body weight is required for calculationsfor these applications.4.4.1.5 Based on the outcome of previous steps, maximumresidual le

39、vels should be set for toxicologically critical ingre-dients (see 4.1).4.4.2 For a proper biosafety analysis, chemical and biologi-cal testing should always be combined, especially since not allpotential adverse effects can be derived from toxicologicalevaluation of only individual ingredients. As a

40、 minimum, thefollowing biological tests should be conducted for medical-grade UHMWPE yarn:4.4.2.1 Cytotoxicity, in accordance with ISO 10993-5.4.4.2.2 Hemolysis, in accordance with Practice F756 andfollowing ISO 10993-4.4.4.2.3 Acute Irritation, in accordance with ISO 10993-10,with a preference for

41、in vitro methods.64.4.2.4 Sensitization, in accordance with ISO 10993-10,with a preference for the Guinea Pig Maximization test.4.4.2.5 Results of above biological tests for the yarns cannotreplace biological evaluation and testing in accordance withISO 10993-1 for the final medical device.Additiona

42、l endpointsmay be necessary; therefore the final medical device manufac-turer should evaluate the finished component or medical devicefor the intended use in accordance with ISO 10993-1.4.4.3 The biosafety assessment described above should bemade available in a material master file. General results

43、shouldbe made available on a certification document for a specificproduct yarn design and corresponding yarn manufacturingprocess.4.4.4 It is important to note that biological safety evaluationis a continuous process. In case of any change in yarn designor its manufacturing process, the yarn manufac

44、turer shouldevaluate the consequences on biological safety and the materialmaster file should be updated accordingly. The user or finalmedical device manufacturer should evaluate the consequenceson biological safety of any additional processes (such as, forexample, from cleaning and sterilization) a

45、nd shall qualify thefinished component or medical device for the intended use.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 liquids shall be determined by gas

46、chromatography or other suitable, validated analytical methodsfor the specific liquids used to produce the yarn to a sufficientaccuracy in relation to the specified value.6.2 If applicable, determine concentrations of color pigmentor specified trace element in accordance with 4.1 by a validatedanaly

47、tical method, such as neutron activation analysis (NAA),inductively coupled plasma spectroscopy (ICP), atomic ab-sorption (AA), or X-ray fluorescence (XRF) to a sufficientaccuracy in relation to the specified value.6.3 Determine the filament linear density by dividing theyarn linear density, measure

48、d in accordance with Test MethodD1907/D1907M, by the number of filaments in the yarn.6.4 The intrinsic viscosity shall be measured in accordancewith ISO 1628-3 or ASTM D1601, but in the case ofincomplete dissolution of the polymer, longer dissolution timesand lower dissolution temperatures may be us

49、ed.6.5 Determine tensile strength, tensile modulus, andelongation-at-break in accordance with the following testconditions, derived from Test Methods D885/D885M, TestMethod D2256/D2256M, and ISO 2062, and optimized forUHMWPE yarns:6.5.1 Test Conditions:6.5.1.1 Temperature shall be 21 6 3C.6.5.1.2 Twisting level shall be in accordance with productspecifications, and any change 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