ASTM F2848-2017 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格》.pdf

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1、Designation: F2848 16F2848 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

2、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 weight polyethylene (UHMWPE) yarns intended for use in medical devic

3、esor components of medical devices, such as sutures and ligament fixations. This specification covers natural (non-colored) andpigmented (colored) yarns.1.2 This standard is intended to describe the requirements and the procedures to be followed for testing UHMWPE yarns as acomponent for medical dev

4、ices prior to manufacturing processes of the medical device such as fabric formation, assembling andsterilization. This specification does not purport to address the requirements for the finished medical devices or the testing that isneeded for medical devices that are fabricated from the components

5、 specified herein.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this stand

6、ard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the De

7、velopment of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementD885/D885M Te

8、st Methods for Tire Cords, Tire Cord Fabrics, and Industrial Filament Yarns Made from ManufacturedOrganic-Base FibersD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1601 Test Method for Dilute Solution Viscosity of Ethylene PolymersD1907/D1907M Test Method for Linear Dens

9、ity of Yarn (Yarn Number) by the Skein MethodD2256/D2256M Test Method for Tensile Properties of Yarns by the Single-Strand MethodF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF756 Practice for Assessment of Hemolytic Properties of MaterialsF2625 Test Method for

10、 Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-MolecularWeight Polyethylene by Means of Differential Scanning Calorimetry2.2 ISO Standards:3ISO 1628-3 PlasticsDetermination of the Viscosity of Polymers in Dilute Solution Using Capillary ViscometersPart 3:P

11、olyethylenes and PolypropylenesISO 2062 TextilesYarns from PackagesDetermination of Single-end Breaking Force and Elongation at BreakISO 10993-1 Biological Evaluation of Medical Devices Part 1 Evaluation and testing within a risk management processsISO 10993-4 Biological Evaluation of Medical Device

12、s Part 4 Selection of tests for interactions with blood1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Jan. 1, 2016May 1, 2017. Pu

13、blished March 2016July 2017. Originally approved in 2010. Last previous edition approved in 20102016 asF284810.16. DOI: 10.1520/F284816.10.1520/F284817.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Sta

14、ndardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from International Organization for Standardization (ISO), 1, ch. de la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.This document is not an ASTM standard and is

15、intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the c

16、urrent versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1ISO 10993-5 Biological Evaluation of Medical Devices Part 5 Tests for in vitro cytotoxicityIS

17、O 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitizationISO 10993-17 Biological Evaluation of Medical Devices Part 17 Establishment for allowable limits for leachable substancesISO 10993-188 Biological Evaluation of Medical Devices Part 18 Chemical cha

18、racterization of materialsISO 13485 Medical Devices Quality Management Systems Requirements for regulatory purposesISO 14971 Medical Devices Application of risk management to Medical Devices2.3 Other Documents:ICH Q3C(R3) International Conference on Harmonisation of Technical Requirements for Regist

19、ration of Pharmaceuticals forHuman Use, Quality Guideline: Impurities: Residual Solvents4US Code of Federal RegulationsCFR section 21 Parts 70, 71, 73, 74 and 80 on color additives for medical devices53. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 UHMWPE filamentmolecularly o

20、riented highly crystalline fiber spun from virgin UHMWPE polymer powder.3.1.2 UHMWPE yarna continuous strand of more than one UHMWPE filaments in a form suitable for operations such asweaving, knitting, etc.3.1.3 linear densitymass per length, expressed in dtex (mass in grams per 10 000 metres).3.1.

21、3.1 DiscussionTex is a unit of measure for the linear mass density of yarns and is defined as the mass in g/1000 m. Because of the low mass ofyarns used in medical applications, decitex (abbreviated as dtex) is more commonly used, and is mass in g/10 000 m. Anotherrelated unit of measure for the lin

22、ear mass density is denier, which is defined as g/9000 m.3.1.4 production liquidany liquid(s) used in the production of the filaments and yarns, such as solvents and extractionsolutions.4. UHMWPE Filament and Yarn Requirements4.1 Compositional Requirements:4.1.1 Maximum acceptable limits for residua

23、l constituents shall be determined based on prevention of adverse effects when usedin a medical application (see also 4.4). Residual constituents can be residues from the used production liquids, processing aids,or residual elements from raw materials.4.1.2 Residual production liquids shall be asses

24、sed with regard to toxicity hazards, with a maximum acceptable limit consistentwith ICH Q3C(R3). If no ICH concentration guideline has been established for a utilized production liquid, a toxicity assessmentand corresponding potential leaching characteristics for the identified potential toxic ingre

25、dients should be performed inaccordance with 4.4 to establish a maximum residual level.4.1.3 Potential effects of residual production liquid(s) on mechanical or physical yarn properties should be considered as wellfor establishing maximum limits.4.1.4 For decalin as solvent, the residual level has b

26、een established in accordance with 4.4 and 4.1.3 and shall be less than 100mg/kg (see 6.1).4.1.5 In case a color additive or pigment is added to the yarn, this should be compliant to the FDA regulation as published inthe US Code of Federal Regulations - CFR section 21, parts 70, 71, 73, 74 and 80 on

27、 color additives for medical devices.4.2 Physical Requirements:4 Available from International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH Secretariat, c/oIFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland, http

28、:/www.ich.org.5 U.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/cm3 Test Methods D792 or D1505 0.95 - 1.00Melting t

29、emperature 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 c

30、ontent, wt.% (Maximum)Chromium-cobalt-aluminum oxide6.2 2F2848 1724.2.1 The density of the yarn shall comply with the requirement listed in Table 1.4.2.2 The linear density requirement of single filaments is listed in Table 1.4.2.3 The intrinsic viscosity requirement for the UHMWPE yarn is listed in

31、 Table 1.4.3 Mechanical Requirements:4.3.1 Tensile testing shall be conducted after sufficient conditioning to the laboratory conditions, with a minimum of 2 h toachieve uniform temperatures within the yarn package.4.3.2 UHMWPE yarns shall meet the tensile requirements on strength, modulus, and elon

32、gation-at-break as listed for individualdata as listed in Table 1. Note that tensile properties of the final medical device depend on the construction of yarns used therein.4.4 Biocompatibility and Biosafety Risk Assessment Requirements:4.4.1 The first principle of ISO 10993-1 states that biological

33、 evaluation of any material or medical device intended for use inhumans shall form part of a structured biological evaluation program within a risk management process in accordance with ISO14971. This should be addressed through chemical characterization of the material, following ISO 10993-18, and

34、toxicologicalassessment based on ISO 10993-17. See the following for more specific specifications for this medical-grade UHMWPE yarn:4.4.1.1 The full quantitative composition of the yarn as component supplied should be established, including residual processingaids and relevant impurities or trace e

35、lements; hereinafter referred to as ingredients.4.4.1.2 For each ingredient, a toxicological assessment should be performed based on ISO 10993-17, which means thatTolerable Intake (TI) values in mg/kg bw/day are derived based on collected information on known critical adverse effects.4.4.1.3 Aworst-

36、case assessment should be performed for each ingredient. Determine whether the quantity established in 4.4.1.1is below the TI as defined in 4.4.1.2 for the application under consideration or, if the application is unknown, for 1 g of yarn (seeAppendix X1.3), assuming a body weight of 5070 kg and ful

37、l bio-availabilitybioavailability of the ingredients within 1 day. The70 kg body weight is not appropriate for pediatric and/or neonate applications. A lower body weight is required for calculationsfor these applications.4.4.1.4 If the worst case worst-case assessment indicates that the TI can be ex

38、ceeded, perform extraction and/or leaching studiesin accordance with ISO 109931099318 and determine whether the extracted/leached amount is below the TI for the applicationunder consideration or, if the application is unknown, for 1 g of yarn,yarn assuming a body weight of 5070 kg andbio-availabilit

39、ybioavailability of the extracted components/leachables within 1 day. The 70 kg body weight is not appropriate forpediatric and/or neonate applications. A lower body weight is required for calculations for these applications.4.4.1.5 Based on the outcome of previous steps, maximum residual levels sho

40、uld be set for thetoxicologically criticalingredients (refer to (see 4.1).4.4.2 For a proper biosafety analysis, chemical and biological testing should always be combined, especially since not allpotential adverse effects can be derived from toxicological evaluation of only individual ingredients on

41、ly. ingredients. As aminimum, the following 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 and following ISO 10993-4.4.4.2.3 Acute Irritation, in accordance with ISO 10993-10,

42、 with a preference for 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 cannot replace biological evaluation and testing in accordance with ISO10993-1 for the final

43、 medical device. Additional endpoints may be necessary; therefore the final medical device manufacturershould evaluate the finished component or medical device for the intended use in accordance with ISO 10993-1.4.4.3 The biosafety assessment described above should be made available in a material ma

44、ster file. General results should bemade available on a certification document for a specific product yarn design and corresponding yarn manufacturing process.4.4.4 It is important to note that biological safety evaluation is a continuous process. In case of any change in yarn design orits manufactu

45、ring process, the yarn manufacturer should evaluate the consequences on biological safety and the material masterfile should be updated accordingly. The user or final medical device manufacturer should evaluate the consequences on biologicalsafety of any additional processes (for example, (such as,

46、for example, from cleaning and sterilization) and shall qualify thefinished component or medical device for the intended use.5. Sampling5.1 Compliance with this specification shall be determined by sampling sizes and procedures as agreed upon between thepurchaser and seller.6. Test Methods6.1 Residu

47、al production liquids shall be determined by gas chromatography or other suitable, validated analytical methods forthe specific liquids used to produce the yarn to a sufficient accuracy in relation to the specified value.6 In vitro methods are preferred above in vivo methods to limit animal testing,

48、 also since the medical-grade UHMWPE yarn component is not a final finished device.F2848 1736.2 If applicable, determine concentrations of color pigment or specified trace element in accordance with 4.1 by a validatedanalytical method, such as neutron activation analysis (NAA), inductively coupled p

49、lasma spectroscopy (ICP), atomic absorption(AA), or X-ray fluorescence (XRF) to a sufficient accuracy in relation to the specified value.6.3 Determine the filament linear density by dividing the yarn linear density, measured in accordance with Test MethodD1907/D1907M, by the number of filaments in the yarn.6.4 The intrinsic viscosity shall be measured in accordance with ISO 1628-3 or ASTM D1601, but in the case of incompletedissolution of the polymer, longer dissolution times and lower dissolution temperatures may be used.6.5 Determine tensile