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This specification describes the required properties and the procedures to be followed for testing ultra-high molecular weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. UHMWPE filament and yarn requirements cover compositional requirements, physical requirements, mechanical requirements, and biocompatibility requirements. Residual production liquids shall be determined by gas chromatography or other suitable, validated analytical methods for the specific materials used to produce the yarn.1.1 This specification covers ultra-high-molecular-weight polyethylene (UHMWPE) yarns intended for use in medical devices or components of medical devices, such as sutures and ligament fixations. This specification covers natural (non-colored) and pigmented (colored) yarns.1.2 This standard is intended to describe the requirements and the procedures to be followed for testing UHMWPE yarns as a component for medical devices prior to manufacturing processes of the medical device such as fabric formation, assembling, and sterilization. This specification does not purport to address the requirements for the finished medical devices or the testing that is needed for medical devices that are fabricated from the 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 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 Every ASTM test method listed in 2.1 contains a section describing its particular significance and use. Other test methods listed in 2.1 of this practice may contain sections pertaining to their particular significance and use.5.2 The physical testing procedures in this practice can be used in conjunction with lot sampling procedures as a basis for acceptance testing of commercial shipments of inflatable restraint fabrics. They may be used to establish the criteria by which inflatable restraint fabrics will be tested by the supplier to determine whether a lot of material is acceptable for shipment to the purchaser.5.3 This practice addresses all the physical properties that describe inflatable restraint fabrics and their commonly used test methods. Unless otherwise specified by agreement of purchaser and supplier, these standard test methods shall constitute the test conditions, procedures, and equipment used to determine the physical properties of fabrics used in inflatable restraints. It is intended to be used as a guideline in establishing a written material specification. The specification or agreement of purchaser and supplier may deviate from the practices described herein when (based on experience) considerations of fabric properties, material handling equipment, or inflatable restraint system design dictate otherwise.1.1 This practice is a listing of the test methods commonly employed in determining the physical properties of fabrics and yarns used in the manufacture of inflatable restraints.1.2 Fabrics used in the manufacture of inflatable restraints may be coated or uncoated, and may be comprised of spun yarns, continuous filament yarns, or a combination thereof.1.3 Fabrics used in the manufacturer of inflatable restraints may be either flat or one piece woven. For the one-piece woven, follow the sampling section of D5446 and the individual test method.1.4 In Section 9, this practice lists is alphabetical order the procedures associated with conducting physical testing of the following fabric or yarn properties of concern to the design and manufacture of inflatable restraints.Yarn Section  Denier (Yarn Number) 9.3.1   Fiber Content 9.3.2   Finish (Extractable Material) 9.3.3   Strength and Elongation 9.3.4   Twist 9.3.5 Fabric    Air Permeability 9.3.6   Abrasion Resistance 9.3.7   Blocking 9.3.8   Bow and Skew 9.3.9   Breaking Force & Elongation 9.3.10  Burst Strength 9.3.11  Coating Adhesion 9.3.12  Coating Weight 9.3.13  Count of Woven Fabric 9.3.14  Dynamic Air Permeability 9.3.28  Edgecomb Resistance 9.3.29  Flammability 9.3.15  Fogging (Volatility) 9.3.16  Length 9.3.17  Mass per Unit Area 9.3.18  Non-Fibrous Material 9.3.19  Odor 9.3.20  Packability 9.3.30  pH 9.3.21  Stiffness 9.3.22  Tear Strength 9.3.23  Thickness 9.3.24  Warp Size Content & Residual Sizing 9.3.25  Width 9.3.26  Sewing Thread 9.3.27 1.5 This practice may be used in conjunction with Practice D5427 which prescribes standard practices for the accelerated aging of inflatable restraint fabrics when comparative results of physical properties before and after accelerated aging are required.1.6 Procedures and apparatus other than those stated in this practice may be used by agreement of purchaser and supplier with the specific deviations from the standard practice acknowledged in the report.1.7 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not exact equivalents; therefore, each system must be used independent of the other.1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.See Note 3.

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5.1 Test Method D6774, for determining maximum total contraction, crimp, and residual fiber shrinkage in textured filament yarns is suitable for acceptance testing of commercial shipments.5.1.1 If there are differences of practical significance between reported test results for two laboratories (or more), comparative tests should be performed to determine if there is a statistical bias between them, using competent statistical assistance. As a minimum, use the samples for such a comparative tests that are as homogeneous as possible, drawn from the same lot of material as the samples that resulted in disparate results during initial testing and randomly assigned in equal numbers to each laboratory. The test results from the laboratories involved should be compared using a statistical test for unpaired data, a probability level chosen prior to the testing series. If a bias is found, either its cause must be found and corrected, or future test results for that material must be adjusted in consideration of the known bias.5.2 The properties and their variability as measured by this method relate to bulk appearance, stretch and recovery of fabrics and dyeability of yarns.5.3 For some yarns, elapsed time between processing and testing has a marked effect on the results, of this test, especially during the first 72 h. The effect is caused by stress decay which is known to be minimal beyond the seventh day and after which time the yarn remains relatively stable. Therefore, specimens should only be compared if tested after the same elapsed time. Samples can be tested at-line, thus having little to no elapsed time between processing and testing.1.1 This test method covers the determination of crimp contraction, residual fiber shrinkage and their variability of all types of filament yarns (partially oriented yarn (POY), fully oriented yarn (FOY), flat yarns, textured and bulked continuous filament (BCF) carpet yarns) using an automated tester.NOTE 1: For another method of testing crimp in textured yarns, refer to Test Method D4031.1.1.1 This method may also be used for non-textured yarns.1.2 This test method is limited to crimped, multi-filament yarns ranging from 22.0 dtex to 890 dtex (15 denier to 800 denier) and for BCF yarns from 890 dtex to 4200 dtex (800 denier to 3800 denier).1.3 The values stated in SI units are to be regarded as standard. Inch-pound units in parentheses after SI units are provided for information only and are not considered standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 These tolerances may be used as a guide in purchaser/supplier disputes, or to assist in assigning nominal values for linear density and twist. The tolerances listed for each property represent the maximum variations deemed acceptable in the trade.1.1 These tolerances cover first-quality, manufactured, organic-base filament single yarns (namely, bright, semi-dull, dull, solution-dyed, bleached, unbleached, etc.) regardless of the package type. These tolerances cover permissible variations in linear density, tenacity, elongation, twist, and commercial weight.1.1.1 These tolerances do not apply to rubber yarns, spandex yarns, metal-covered yarns, nor to bulk yarns since test methods for these types of yarn are not available. These tolerances do not apply to industrial filament yarns.NOTE 1: Tolerances for inorganic glass yarns are given in Specifications and Methods D578/D578M.1.2 This standard covers only tolerances. It does not cover specifications or quality levels, for yarns to be used for any purpose. Specifications for specific properties are subject to agreement by the purchaser and the supplier.NOTE 2: While the tolerances specified may be applied to yarn taken from fabric, the properties of such yarns will likely differ from the original level.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The procedures in these test methods should be used with caution for acceptance of commercial shipments owing to the absence of factual information on the between-laboratory precision of many of the test procedures included in these test methods. It is recommended that any program of acceptance testing be preceded by an interlaboratory check in the laboratory of the purchaser and the laboratory of the supplier on replicate specimens of the materials to be tested for each property (or properties) to be evaluated.5.1.1 If there are differences of practical significance between reported test results for two laboratories (or more), comparative tests should be performed to determine if there is a statistical bias between them, using competent statistical assistance. As a minimum, test samples should be used that are as homogeneous as possible, that are drawn from the material from which the disparate test results were obtained, and that are randomly assigned in equal numbers to each laboratory for testing. Other materials with established test values may be used for this purpose. The test results from the two laboratories should be compared using a statistical test for unpaired data, at a probability level chosen prior to the testing series. If a bias is found, either its cause must be found and corrected, or future test results must be adjusted in consideration of the known bias.5.2 The significance and use of particular properties are discussed in the appropriate sections of specific test methods.1.1 These test methods cover the testing of industrial filament yarns made wholly of manufactured organic-base fibers, cords twisted from such yarns, fabrics woven from such cords, and products that are made specifically for use in the manufacture of pneumatic tires. They may be applied to similar yarns and cords used for reinforcing other rubber goods and for other industrial applications. The test methods apply to nylon, polyester, and rayon yarns and tire cords twisted from such yarns and to fabrics made from such cords. The yarn or cord may be wound on cones, tubes, bobbins, spools, or beams; may be woven into fabric; or may be in some other form. The methods include testing procedure only and include no specifications or tolerances.1.2 No procedure is included for the determination of fatigue resistance of cord, but several commonly used procedures for the measurement of fatigue resistance of cords in rubber were published in the appendix of these test methods in the 1967 Annual Book of ASTM Standards, Part 24, and in earlier issues of Test Methods D885.1.3 The sections on “Growth of Conditioned Yarns and Cords,” “Properties of Yarns and Cords at Elevated Temperature,” and “Properties of Wet Yarns and Cords” have been moved to Appendix X1 – Appendix X3 as non-mandatory informational items because of their very limited use by the industry and because precision and bias statements are not included.1.4 This standard includes the following sections:  SectionAdhesion of Cord to Elastomers 34Bibliography of Tire Cord Test Methods X5Breaking Strength (Force) of Yarns and Cords at Elevated Tempera- ture X2.3Breaking Strength (Force) of Conditioned Yarns and Cords 16Breaking Strength (Force) of Oven-Dried Rayon Yarns and Cords 23Breaking Strength (Force) of Rayon Yarns and Cords at Specified Moisture Regain Level, Adjustment of 17Breaking Tenacity of Conditioned Yarns and Cords 18Breaking Tenacity of Oven-Dried Rayon Yarns and Cords 24Breaking Toughness of Yarns and Cords 28Commercial Mass 9Conditioning 7Contraction of Wet Yarns and Cords X3Count of Tire Cord Fabric 37Dip (Adhesive) Solids Pickup on Yarns and Cords 33Elongation at Break of Conditioned Yarns and Cords 19Elongation at Break of Oven-Dried Rayon Yarns and Cords 25Elongation of Rayon Yarns and Cords at a Specified Moisture Regain Level, Adjustment of Observed 20Extractable Matter in Yarns and Cords 32Force at Specified Elongation (FASE) of Conditioned Yarns and Cords 21Force at Specified Elongation (FASE) of Oven-Dried Rayon Yarns and Cords 26Growth of Conditioned Yarns and Cords X1Identification of Fibers 8Keywords 40Linear Density 11Mass of per Unit Area of Tire Cord Fabric 36Modulus of Conditioned Yarns and Cords 22Moisture Regain, Actual 10Precision and Bias of Certain Yarn and Cord Tests 39  35 toProperties of Tire Cord Fabric 38Sampling 6Shrinkage Force of Conditioned Yarns and Cords at Elevated Temper- ature  X2.5Shrinkage of Conditioned Yarns and Cords at Elevated Temperature X2.4, General 5, Tensile Properties 14SI Calculations (examples for work-to-break, specific work-to-break, and breaking toughness)  X4Stiffness of Fabric 38  12 toTensile Properties of Yarns and Cords 28Terminology 3Thickness of Cords 31Twist in Yarns and Cords 30Width of Tire Cord Fabric 35Work-to-Break of Yarns and Cords 271.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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5.1 Option 1 of this test method is for the determination of the degree of filament yarn entanglement, as measured instrumentally. It is used for acceptance testing of commercial shipments; however, caution is advised because information on between-laboratory precision is lacking. Comparative tests, as directed in 5.1.1, may be advisable.5.1.1 If there are differences of practical significance between the reported test results for two or more laboratories, comparative tests should be performed by those laboratories to determine if there is a statistical bias between them, using competent statistical assistance. As a minimum, samples used for each comparative test should be as homogeneous as possible, drawn from the same lot of material as the samples that results in disparate results during initial testing, and randomly assigned in equal numbers to each laboratory. Other fabrics with established test values may be used for this purpose. The test results from the laboratories involved should be compared statistically. If a bias is found, either its cause must be found and corrected or future test results must be adjusted in consideration of the known bias.5.2 Option 2 for this test method is intended for use when the supply of yarn is limited.5.3 The instrumental option of this test method, Option 1, is based on the total randomization of the entanglements in the yarn; therefore, the distance measured between the point of insertion of a pin in the middle of the yarn and the point at which an entanglement is encountered, by movement of the yarn or the pin until it is stopped at a preset level of force, is representative of the distance between two entanglements at some location in the yarn.5.4 Entanglements are used frequently instead of twist to ensure the integrity of filament yarns. Such entanglements generally give somewhat less protection during weaving or knitting than twist, but with proper care, will perform quite satisfactorily.1.1 This test method covers two options for the measurement of entanglements in filament yarns using needle insertion options for instrument (Option 1) (Option 2) techniques.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价: 590元 / 折扣价: 502 加购物车

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