定价： 0元 / 折扣价： 0 元

定价： 481元 / 折扣价： 409 元

This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy bars, rods, wires, sheets, and strips (except surgical fixation wires) for use in surgical implants. All alloys shall be furnished to the purchaser's specifications, in the annealed or cold-worked condition. Then, bars and wires shall be finished bright annealed, cold drawn, pickled, ground, or ground and polished, as specified by the purchaser. While, sheets shall be furnished bright annealed, pickled, cold-rolled, or polished, as specified by the purchaser. The alloys shall adhere to specified values of ultimate tensile strength, yield strength, elongation, and microcleanliness.1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F1091).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 may not be 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 元 加购物车

4.1 Spinal implant constructs are typically a compilation of several components. Screws, plates, and rods are integral components of many spinal implant constructs. These components are designed to transfer load between the bone and the longitudinal or transverse element, or both. These specifications and test methods identify specifications for such components and define standard equivalent test methods that can be used when evaluating different related component designs.4.2 Since the loading of spinal components in-vivo may differ from the loading configurations addressed in these specifications and test methods, the results obtained from this document may not predict in-vivo performance of either the components or the construct as a whole. Such tests can, however, be used to compare different component designs in terms of relevant mechanical performance characteristics.4.3 The performance-related mechanical characteristics determined by these specifications and test methods will supply the user with information that may be used to predict the mechanical performance of different design variations of similar (function and indication) spinal construct components.AbstractThese specifications and test methods provide standard specifications that specify material, labeling, and handling requirements for components used in surgical fixation of the spinal skeletal system such as metallic spinal screws, spinal plates, and spinal rods. The specifications and test methods establish (1) common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components, and (2) performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components and to describe or specify specific designs for the individual components. For these specifications and test methods may not be appropriate for all types of spinal surgical fixation systems, the appropriateness of these specifications in view of the particular implant system and its potential application shall be considered. The test methods include static and fatigue bending strength tests. Requirements for marking and packaging are specified as well.1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components.1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798. At the highest level in this chain is Test Methods F1717, which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies.1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components addressed by this document. Insufficient knowledge to predict the consequences of using any of these components in individual patients for specific activities of daily living is available. Furthermore, it is not the intention of this document to describe or specify specific designs for the individual components of systems used in the surgical internal fixation of the spinal skeletal system.1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user is cautioned to consider the appropriateness of this document in view of the particular implant system and its potential application.1.5 This document includes the following specifications and test methods that are used in determining the spinal component's mechanical performance characteristics:1.5.1 Specification for Metallic Spinal Screws—Annex A1.1.5.2 Specification for Metallic Spinal Plates—Annex A2.1.5.3 Specification for Metallic Spinal Rods—Annex A3.1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws—Annex A4.1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard.1.7 This standard may involve hazardous materials, operations, and equipment. 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.1.8 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： 646元 / 折扣价： 550 元 加购物车

5.1 This test method is intended to help assess the degradation rates (that is, the mass loss rate) and changes in material or structural properties, or both, of HDP materials used in surgical implants. Polymers that are known to degrade primarily by hydrolysis include but are not limited to homopolymers and copolymers of l-lactide, d-lactide, d,l-lactide glycolide, caprolactone, and p-dioxanone.75.2 This test method may not be appropriate for all types of implant applications or for all known absorbable polymers. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application (see X1.1.1).5.3 Since it is well known that mechanical loading can increase the degradation rate of absorbable polymers, the presence and extent of such loading needs to be considered when comparing in vitro behavior with that expected or observed in vivo.5.3.1 Mechanically Unloaded Hydrolytic Evaluation—Conditioning of a hydrolysable device under mechanically unchallenged hydrolytic conditions at 37°C in buffered saline is a common means to obtain a first approximation of the degradation profile of an absorbable material or device. It does not necessarily represent actual in vivo service conditions, which can include mechanical loading in a variety of forms (for example. static tensile, cyclic tensile, shear, bending, and so forth). If the performance of a device under its indicated use includes loading, hydrolytic aging alone is NOT sufficient to fully characterize the device.5.3.2 Mechanically Loaded Hydrolytic Evaluation—The objective of loading is to approximate (at 37°C in buffered saline) the actual expected device service conditions so as to better understand potential physicochemical changes that may occur. Such testing can be considered as necessary if loading can be reasonably expected under in vivo service conditions. When feasible, test specimens should be loaded in a manner that simulates in vivo conditions, both in magnitude and type of loading. Clinically relevant cyclic load tests may include testing to failure or for a specified number of cycles followed by testing to evaluate physicochemical properties.5.3.2.1 Static Loading—It is notable that for some polymeric materials it has been shown that a constant load results in the same failure mechanism (for example, creep) and is the worst case when compared to a cyclic load (where the maximum amplitude of the cyclic load is equal to the constant load). Thus, in specific cases it may be acceptable to simplify the test by using a constant load even when the anticipated in vivo loading is cyclic. It is encumbent upon the user of this test method to demonstrate through experiment or specific reference that this simplification is applicable to the polymer under investigation and does not alter the failure mode of the test specimen. If such evidence is not available ,it is necessary to recognize that static loading and cyclic loading are measuring different material properties and are not comparable. Using one to replace the other could lead to misinterpretation of the results.NOTE 3: Caution must be taken to ensure that fixturing does not introduce artifactual performace or degradation issues, or both. An example is the use of rigid foam block, which restricts swelling & expansion and can elevate pull out strength test results from sample compression within the block. Additionally, restricted perfusion due to the closed cell nature of the foam can result in concentration of acidic byproducts that result in accelerated degradation when compared to a normally perfused and buffered in vivo condition.NOTE 4: When performing degradation testing under load, it may be necessary to consider and monitor polymer creep during testing, which may be significant.5.4 Absorbable devices subjected to flow conditions (for example, vascular stents, particularly those with a drug eluting component) may degrade more rapidly than the same device maintained under static degradation test conditions. When it is feasible to estimate the flow conditions that an implant will be subjected to in vivo and replicate them in vitro the degradation study should be conducted under flow conditions. However, details regarding appropriate flow modeling are beyond the scope of this test method.5.5 Sterilization of HDP materials should be expected to cause changes in molar mass or structure, or both, of the polymers. This can affect the initial mechanical and physical properties of a material or device, as well as its subsequent rate of degradation. Therefore, if a test is intended to be representative of actual performance in vivo, specimens shall be packaged and sterilized in a manner consistent with that of the final device. Non-sterilized specimens may be included for comparative purposes.1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.1.2 The requirements of this test method apply to HDPs in various forms:1.2.1 Virgin polymer resins, or1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 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.

定价： 590元 / 折扣价： 502 元 加购物车

1.1 This terminology defines basic terms and considerations for components of thumb-type surgical forceps. Instruments with this terminology are limited to those fabricated from stainless steel and used for surgical procedures.1.2 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： 515元 / 折扣价： 438 元 加购物车

This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories in the measurement of chemical content. Tension test and bend test shall be performed to meet the requirements specified.1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.3 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 元 加购物车

5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):(1) Accuracy of a single point relative to a coordinate system.(2) Sensitivity of tracking accuracy due to changes in pointer orientation.(3) Relative point-to-point accuracy.1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.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.

定价： 590元 / 折扣价： 502 元 加购物车

3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic surgical implants.1.1 This practice is intended as a standard for fluorescent penetrant inspection of metallic surgical implants.1.2 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.1.3 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： 515元 / 折扣价： 438 元 加购物车

This specification covers the requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel- 7molybdenum alloy in the form of wire and strip used for the manufacture of surgical implants. The heat analysis shall conform to the prescribed chemical composition requirements of grade 1 or 2. The tensile strength, hardness, yield strength, elongation, and microstructure shall be tested to meet the requirements specified.1.1 This specification covers the chemical, mechanical, and metallurgical requirements for two grades of wrought 40cobalt-20chromium-16iron-15nickel-7molybdenum alloy in the form of wire, strip and bar used for the manufacture of surgical implants.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

This specification covers the chemical composition and mechanical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) forgings for use in surgical implants. The material covered here shall be in the form of bars, plates, sheets, or wires manufactured in the solution-annealed condition with a finish suitable for forging by hammering, pressing, rolling, extruding, or upsetting.1.1 This specification covers the chemical, mechanical, and metallurgical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of forgings, used for the manufacture of surgical implants.1.2 Units—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： 618元 / 折扣价： 526 元 加购物车

This guide covers extensively irradiation-crosslinked ultra-high molecular weight polyethylene (UHMWPE) fabricated forms for surgical implant applications. Only gamma and electron beam irradiated extensively crosslinked materials are covered by this guide. Chemical composition and physical properties of extensively crosslinked UHMWPE fabricated form shall conform to the requirements of this guide which include ultimate tensile strength, yield strength, elongation, Izod impact strength, ultimate load, fatigue crack propagation, compressive modulus, percent crystallinity, melting temperature, residual free radicals, swell ratio, oxidation index, and t-vinylene content. Biocompatibility of the material shall also be considered when new applications of the material, or modification to the material or physical forms of the materials are being contemplated.1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Specification F648.1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide: 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.1.6 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： 515元 / 折扣价： 438 元 加购物车

Scaffolds may be composed of purely mineral or ceramic materials, or they may be composed of a composite material with its main phase being a mineral or ceramic. Scaffolds may be porous or non-porous, mechanically rigid or compliant, and degradable or non-degradable. The scaffold may or may not have undergone a surface treatment.1.1 This guidance document covers the chemical, physical, biological, and mechanical characterization requirements for biocompatible mineral- and ceramic-based scaffolds used solely as device or to manufacture tissue-engineered medical products (TEMPs). In this guide, the pure device or the TEMPs product will be referred to as scaffold.1.2 The test methods contained herein provide guidance on the characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. These properties may be important for the performance of the scaffold, especially if they affect cell behavior, adhesion, proliferation and differentiation. In addition, these properties may affect the delivery of bioactive agents, the biocompatibility and the bioactivity of the final product.1.3 This document may be used as guidance in the selection of test methods for the comprehensive characterization of a raw materials, granules, pre-shaped blocks, or an original equipment manufacture (OEM) specification. This guide may also be used to characterize the scaffold component of a finished medical product.1.4 While a variety of materials can be used to manufacture such scaffolds, the composition of the final scaffold shall contain mineral or ceramic components as its main ingredients.1.5 This guide assumes that the scaffold is homogeneous in nature. Chemical or physical inhomogeneity or mechanical anisotropy of the scaffold shall be declared in the manufacturer’s material and scaffold specification.1.6 This guide addresses neither the biocompatibility of the scaffold, nor the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold.1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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 and health practices and determine the applicability of regulatory limitations prior to use.

定价： 0元 / 折扣价： 0 元

5.1 The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after 6 h. Optionally, measurements of persistent activity after a 3 h period and measurements of cumulative activity may be made after repetitive uses over a five day period.1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.1.2 A knowledge of microbiological techniques is required for these procedures.1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR, Parts 50 and 56)1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow in parentheses.1.5 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.1.6 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 元 加购物车

This specification covers virgin poly(L-lactic acid) resin (PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric compositions based on various D, L, or DL copolymer ratios. This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material. The virgin polymer shall be a homopolymer of L-lactide with the prescribed density. The molecular mass of the virgin polymer shall be indicated by relative solution viscosity (in chloroform). In addition, the weight average molecular mass and molecular mass distributions may be determined by gel permeation chromatography The virgin polymer shall be identified as a polylactide by infrared or 1H-NMR spectroscopy. Typical infrared transmission and 1H-NMR spectra are shown. The virgin polymer shall have a specific optical rotation (in dichloromethane) and residual monomer content within the prescribe values, and shall conform to the chemical and physical property requirements specified for: residual solvent, residual water, residual tin, heavy metals, and sulfated ash. The following test methods shall be used: (1) Karl-Fischer titration and (2) atomic absorption-emission (AA) spectroscopy or inductively coupled plasma (ICP) spectroscopy. Considerations for biocompatibility of the material from a human implant perspective is also given.1.1 This specification covers virgin semi-crystalline poly(l-lactide) or poly(d-lactide) homopolymer resins intended for use in surgical implants. This specification also covers semi-crystalline resins of l-lactide copolymerized with other bioabsorbable monomers including, but not limited to, glycolide, d-lactide, and dl-lactide. The poly(l-lactide) or poly(d-lactide) based homopolymers and copolymers covered by this specification possess lactide segments of sufficient length to allow potential for their crystallization upon annealing.1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic dl-lactide based polymers and copolymers as well as the isotactic d-PLA and l-PLA moieties, each of which carries potential for crystallization. Inclusion of stereoisomeric specificity within the lactic acid based acronyms results in the following: poly(l-lactide) as PlLA for poly(l-lactic acid), poly(d-lactide) as PdLA for poly(d-lactic acid), and poly(dl-lactide) as PdlLA for poly(dl-lactic acid).1.3 This specification is applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization. Such polymers typically possess nominal mole fractions that equal or exceed 50 % l-lactide. This specification is particularly applicable to isotactic-lactide based block copolymers or to polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by more than 1.5 total mole percent (1.5 % of total moles). This specification is not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction), which are covered by Specification F2313. This specification is not applicable to amorphous polymers or copolymers synthesized from combinations of d-lactide and l-lactide that differ by less than 1.5 total mole percent (1.5 % of total moles) as covered by Specification F2579.1.4 This specification covers virgin semi-crystalline poly(lactide)-based resins able to be fully solvated at 30 °C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide:glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide-based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions (see Specification F2313).1.5 Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm after annealing above the glass transition temperature. While other copolymeric segments may also crystallize upon annealing (for example, glycolide), specific characterization of crystalline structures other than those formed by lactide are outside the scope of this specification.1.6 This specification addresses material characteristics of the virgin semi-crystalline poly(lactide)-based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials.1.7 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy.1.8 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices.1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.10 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.1.11 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 元 加购物车