ASTM F2848-2016 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 10F2848 16Standard 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 required properties requirements and the procedures to be followed for testingUHMWPE yarns as raw mat

4、erials for medical devices. a component for medical devices prior to manufacturing processes of themedical device such as fabric formation, assembling and sterilization. This specification does not purport to address therequirements for the finished medical devices or the testing that is needed for

5、medical devices or components of medical devicesthat are fabricated from the raw materials components 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 The following precautionary caveat pertains only to

6、 the test method portion, Section 6, of this specification: This standarddoes not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of thisstandard to establish appropriate safety and health practices and determine the applicability

7、of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementD885D885/D885M Test Methods for Tire Cords, Tire Cord Fabrics, and Industrial Filament Yarns Made from ManufacturedOrgani

8、c-Base FibersD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1601 Test Method for Dilute Solution Viscosity of Ethylene PolymersD1907D1907/D1907M Test Method for Linear Density of Yarn (Yarn Number) by the Skein MethodD2256D2256/D2256M Test Method for Tensile Properties o

9、f Yarns by the Single-Strand MethodF648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF756 Practice for Assessment of Hemolytic Properties of MaterialsF26

10、25 Test Method for 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 V

11、iscometersPart 3:Polyethylenes and PolypropylenesISO 2062 TextilesYarns from PackagesDetermination of Single-end Breaking Force and Elongation at BreakISO 1099310993-1 Biological Evaluation of Medical Devices Part 1 Evaluation and testing within a risk managementprocesssISO 10993-4 Biological Evalua

12、tion of Medical Devices 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 June

13、1, 2010Jan. 1, 2016. Published July 2010March 2016. Originally approved in 2010. Last previous edition approved in 2010 as F284810.DOI: 10.1520/F284810.10.1520/F284816.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual

14、Book of ASTM Standardsvolume 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

15、standard and is 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

16、cases only the current 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 vitr

17、o cytotoxicityISO 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 10993-18 Biological Evaluation of Medical Devices Part

18、18 Chemical characterization 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 Requirem

19、ents for Registration 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 filame

20、ntmolecularly oriented 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., prior to packaging and sterilization.etc.3.1.3 linear densitymass per length

21、, expressed in dtex (mass in grams per 10 000 metres).3.1.3.1 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

22、 in g/10 000 m. Anotherrelated unit of measure for the linear 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 Compositiona

23、l Requirements:4.1.1 Current yarns used for medical application with clinicalMaximum acceptable limits for residual constituents shall bedetermined based on prevention of adverse effects when used in a medical application (see also 4.4history are produced withdecalin as solvent. The maximum decalin

24、residual level is 100 mg/kg (see). Residual constituents can be residues from the usedproduction liquids, processing aids, or residual elements 6.1).from raw materials.4.1.2 In case other production liquids are used, the acceptable residual levels of these particular production liquid(s) shall beref

25、lective of toxicity, with Residual production liquids shall be assessed with regard to toxicity hazards, with a maximumacceptable limit consistent with ICH Q3C(R3). If no ICH concentration guideline has been established for a utilized productionliquid, proof of biocompatibility has a toxicity assess

26、ment and corresponding potential leaching characteristics for the identifiedpotential toxic ingredients should be performed in accordance with 4.4 to be given.establish a maximum residual level.4.1.3 Potential effects of residual production liquid(s) on mechanical or physical yarn properties should

27、be considered as wellfor establishing maximum limits.4.1.4 For decalin as solvent, the residual level has been established in accordance with 4.4 and 4.1.3 and shall be less than 100mg/kg (see 6.1).4.1.5 To promote consistency in production and pureness of the yarn, concentration limits for trace el

28、ements have beenestablished and are listed In case a color additive or pigment is added to the yarn, this should be compliant to the FDA regulationas published in Table 1.the US Code of Federal Regulations - CFR section 21, parts 70, 71, 73, 74 and 80 on color additives formedical devices.4.2 Physic

29、al Requirements:4.2.1 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 Table 1.4.3 Mechanical Requirements:4.3.1 Tensile

30、 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 Available from International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

31、(ICH), ICH Secretariat, c/oIFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland, http:/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.htmF2848 1624.3.2 UHMWPE yarns s

32、hall meet the tensile requirements on strength, modulus, and elongation-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 Requirement

33、s:4.4.1 The UHMWPE yarn shall be biocompatible. While the biocompatibility of UHMWPE powder and fibers has beencharacterized first principle of ISO 10993-1 states that biological evaluation (1-8), this data cannot be assumed to be appropriatefor all uses of UHMWPE. When new applications of the mater

34、ial, or modification to the material or physical forms of the materialsare being contemplated, biological testing shall be selected and conducted of any material or medical device intended for use inhumans shall form part of a structured biological evaluation program within a risk management process

35、 in accordance with PracticeF748 or ISO 10993, depending on the available published biocompatibility data and the end-use application. ISO 14971. Thisshould be addressed through chemical characterization of the material, following ISO 10993-18, and toxicological assessmentbased on ISO 10993-17. See

36、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 elements; hereinafter referred to as ingredients.4.4

37、.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-case assessment should be performed for each ingred

38、ient. 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 50 kg and full bio-availability of the ingredients within 1 day.4.

39、4.1.4 If the worst case assessment indicates that the TI can be exceeded, perform extraction and/or leaching studies inaccordance with ISO 10993 and determine whether the extracted/leached amount is below the TI for the application underconsideration or, if the application is unknown, for 1 g of yar

40、n, assuming a body weight of 50 kg and bio-availability of theextracted components/leachables within 1 day.4.4.1.5 Based on the outcome of previous steps, maximum residual levels should be set for the critical ingredients (refer to 4.1).4.4.2 For a proper biosafety analysis, chemical and biological

41、testing should always be combined, especially since not allpotential adverse effects can be derived from toxicological evaluation of individual ingredients only.As a minimum, the followingbiological tests should be conducted for medical-grade UHMWPE yarn:4.4.2.1 Cytotoxicity, in accordance with ISO

42、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, 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.

43、3 The biosafety assessment described above should be made available in a material master file. General results should bemade available on a certification document for a specific product yarn design and corresponding yarn manufacturing process.6 The boldfaceIn vitro numbers methods are preferred abov

44、e in parenthesesvivo refer to a list of references at the end of this standard.methods to limit animal testing, alsosince the medical-grade UHMWPE yarn component is not a final finished device.TABLE 1 Requirements for UHMWPE YarnsProperty Test Method RequirementTrace ElementsDensity, g/cm3 Test Meth

45、ods D792 or D1505 0.95 - 1.00Titanium, mg/kg (Maximum) 6.2 25Sodium, mg/kg (Maximum) 6.2 50Chromium, mg/kg (Maximum) 6.2 10Melting temperature peak, C Test Method F2625 140 - 150Iron, mg/kg (Maximum) 6.2 100Filament Linear Density, dtex (Maximum) 6.3 2.7Calcium, mg/kg (Maximum) 6.2 100Intrinsic Visc

46、osity, dl/g (Minimum) 6.4 15Density, g/cm3 Test Methods D792 0.950.98Tensile Strength, cN/dtex (Minimum) 6.5 26Filament Linear Density, dtex (Maximum) 6.3 2.7Intrinsic Viscosity, dl/g (Minimum) 6.4 12.5Tensile Modulus, cN/dtex (Minimum) 6.5 750Tensile Strength, cN/dtex (Minimum) 6.5 28.0Elongation-a

47、t-break, % 6.5 2 - 5Tensile Modulus, cN/dtex (Minimum) 6.5 750Additional requirement for colored yarn:Elongation-at-break, % 6.5 2.94.3Pigment content, wt.% (Maximum)Chromium-cobalt-aluminum oxide6.2 2F2848 1634.4.4 It is important to note that biological safety evaluation is a continuous process. I

48、n case of any change in yarn design orits manufacturing 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 o

49、f any additional processes (for example, cleaning and sterilization) and shall qualify the finished component or medicaldevice 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 Residual production liquids shall be determined by gas chromatography or other suitable, validated analytical methods forthe specific materialsliquids used to produce the yarn.yarn to a sufficient accuracy in relation to the specifi