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
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