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This specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium phosphate for surgical implant applications. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate. The calcium and phosphorus content shall be determined using a suitable method such X-ray fluorescence. A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determined using powder diffraction method. The analysis of other trace elements may be required, based on the conditions, apparatus, or environment. It is recommended that all metals or oxides present in concentrations equal or greater than 0.1 % be noted in material descriptions.1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (β-TCP) raw materials intended for use in medical device applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).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.

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4.1 The physico-chemical characteristics of the raw or starting material used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting materials to ensure reproducibility prior to their fabrication into implantable tissue-engineering scaffolds and/or controlled release matrices.AbstractThis guide addresses material characteristics of raw or virgin materials in a nonfabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. The substrate material shall have specifications for an extensive set of chemical and physical properties prescribed. Test methods shall be performed in order to determine the chemical and physical properties of the material.1.1 This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials that are already in a scaffold form or are finished tissue-engineered medical products.1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials for which a standard does not exist.1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques.1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.

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1.1 This specification covers basic characteristics required for porous laminated phenolic materials intended for use as instrument and thin-section ball-bearing retainers (cages) and the methods of determining these characteristics.1.2 Forms—Sheets, rolled tubes, molded tubes, and rods are recommended forms of laminated material covered by this specification.1.3 Intended Use—Materials produced to this specification are intended for use as ball-bearing retainers (cages). Temperature range is limited to 250 °F (117 °C) and below.1.4 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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, 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.

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ASTM D763-06(2019) Standard Specification for Raw and Burnt Umber Pigments Active 发布日期 :  1970-01-01 实施日期 : 

This specification covers raw and burnt umber pigments. The pigments could be in a dry or paste in oil form. Dry pigments should conform to the composition requirements for iron oxide content, calcium compound content, moisture and other volatile matter content, coarse particle content, and organic color content. Raw umber dry pigments should be in a soft, dry form and made from a hydrated iron oxide permeating a siliceous base and free of admixtures. Burnt umber dry pigments should be produced by raw amber calcination and free of admixtures. Paste in oil pigments should conform to the specified pigment content, nonvolatile vehicle content, moisture by distillation content, and coarse particle and skin content. Both raw and burnt umber paste in oil pigments should be made by thoroughly grinding the pigment with linseed oil with a small amount of wetting or dispersing agents.1.1 This specification covers the pigments commercially known as raw umber and burnt umber.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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.

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AbstractThese test methods cover the determination of the content of 5-ethylidenenorbornene (ENB) or dicyclopentadiene (DCPD) in ethylene-propylene-diene (EPDM) terpolymers. They are applicable to diene contents in the 0.1 to 10 mass % range. The different apparatus used for testing are presented in details. The methods for the preparation of the test specimen are presented in details. The precision and bias for ENB shall be prepared to meet the requirements prescribed. The precision and bias for DCPD shall be prepared to meet the requirements prescribed.1.1 These test methods cover the determination of the content of 5-ethylidenenorbornene (ENB) or Dicyclopentadiene (DCPD) in ethylene-propylene-diene (EPDM) terpolymers. They are applicable to diene contents in the 0.1 to 10 mass % range.1.2 ENB and DCPD are dienes introduced in ethylene/propylene rubbers to generate specific cure properties. Since high precision for diene content determination has become very important, a Fourier Transform Infrared Spectroscopic (FTIR) method was developed. Diene determination was performed in the past by a refractive index technique.NOTE 1: The procedures for % ENB and % DCPD differ only in the location in the infrared (IR) of the IR peak being quantified.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 The processing behavior (processability) of rubber or rubberlike materials is closely related to their viscoelastic properties. The viscoelastic properties as well as the mechanical properties are related to the polymeric, including macromolecular and micromolecular structure. Therefore, a determination of the viscoelasticity of a material will provide information to predict processing and service performance.5.2 Stress relaxation testing provides a methodology for investigating the viscoelasticity of rubber or rubberlike materials. Certain structural characteristics that have been demonstrated to be evaluated by this test method are: (1) average molecular weight, (2) molecular weight distribution, (3) linearity or chain branching, (4) gel content, and (5) monomer ratio.5.3 This practice is intended to describe various methods of measuring the stress relaxation properties of raw rubber, unvulcanized rubber compounds, or thermoplastic elastomers for determining the processability of these materials through viscoelastic measurements. Factory performance characteristics that this methodology may correlate with include die swell or shrinkage, extrusion rate, mill banding, carbon black incorporation time, and mold flow.1.1 This practice covers several different techniques for determining the stress relaxation characteristics of rubber and rubberlike materials and for the possible interconversion of this stress relaxation information into dynamic mechanical properties.1.2 The techniques are intended for materials having stress relaxation moduli in the range of 103 to 108 Pa (0.1 to 1.5 × 104 psi) and for test temperatures from 23 °C to 225 °C (73 °F to 437 °F). Not all measuring apparatus may be able to accommodate the entire ranges. These techniques are also intended for measurement of materials in their rubbery or molten states, or both.1.3 Differences in results will be found among the techniques. Because of these differences, the test report needs to include the technique and the conditions of the test. This information will allow for resolving any issues pertaining to the test measurements.1.4 The generalized descriptions of apparatus are based on the measurement of force as a function of time. Mathematical treatment of that relationship produces information that can be representative of material properties. Mathematical transformation of the force measurements will first yield stress relaxation moduli with subsequent transformation producing dynamic mechanical properties.1.5 The values stated in SI units are to be regarded as the standard. The values given in parentheses are provided for information only.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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 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 viscous and elastic behavior of unvulcanized rubbers and rubber compounds is of paramount importance in rubber manufacturing, since it affects processing, such as mixing, calendering, extrusion, and molding. The uniformity of these properties is equally important, as fluctuations will cause upsets in manufacturing processes.5.2 A test capable of measuring viscosity and elasticity of unvulcanized rubbers and rubber compounds, including their uniformity and prediction of processing behavior, is therefore highly desirable (see Practice D6048 for further information).5.3 Compared to many other rheological tests, this test method measures viscosity and elasticity related parameters under conditions of low shear and has a high discriminating power. It can detect small rheological differences. A full discussion of the principles behind stress relaxation testing is given in Practice D6048.5.4 Test results of this test method may be useful in predicting processability, but correlation with actual manufacturing processes must be established in each individual case, since conditions vary too widely.5.5 This test method is suitable for specification compliance testing, quality control, referee purposes, and research and development work.1.1 This test method is an adaptation of the German Standard DIN 53514, a further development of the former “Defo Test” (see Appendix X1).1.2 This test method is capable of measuring and characterizing the rheological behavior (viscosity and elasticity) of unvulcanized raw rubbers and rubber compounds, relating to the macro structure of rubber polymers (average molecular weight, molecular weight distribution, long chain branching, and micro- and macro-gel).1.3 The viscosity and elasticity of unvulcanized rubbers and rubber compounds are determined by subjecting cylindrical test pieces to a compression/recovery cycle. The dependency on shear rate at constant shear stress is evaluated and the material fatigue behavior is determined in repeat cycle testing.1.4 The non-Newtonian viscous and elastic behavior of rubbers and rubber compounds can also be evaluated.1.5 Statistical evaluation of the test data provides an indication of data variation, which may be employed as an estimate of the homogeneity of the material tested.1.6 The values stated in SI units are to be regarded as the standard. The values in parentheses are for information only.1.7 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.

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5.1 This test method is considered satisfactory for use as a referee method for the determination of the wool base content and the clean wool fiber present in a lot of raw wool. If there are differences of practical significance between reported test results for two laboratories (or more), comparative test 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 test that are as homogenous as possible, drawn from the same lot of material as the samples that resulted in the disparate results during the 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, probability level chosen prior to the testing series. If bias is found, either its cause must be found and corrected, or future results for that material be adjusted in consideration of the known bias.5.2 This test method is also used in studies aimed at deriving suitable formulas for estimating the allowances to be made for wool unavoidably lost or destroyed in such commercial operations as carding, combing, or carbonizing.1.1 This test method covers the determination of the wool base content and the clean wool fiber present in a lot of raw wool by commercial-scale scouring of the lot followed by laboratory tests on samples of the scoured wool.NOTE 1: The sampling of lots of raw wool in packages is covered in Practice D1060, and the determination of the wool content of such samples is covered in Test Method D584. The determination of vegetable matter and other alkali-insoluble impurities in scoured wool is covered in Test Method D1113. For factors for the conversion of wool base content to its equivalent in terms of scoured wool, top, or noil of various commercially specified compositions, refer to Practice D2720.NOTE 2: The values stated in U.S. Customary Units are to be regarded as the standard because of common commercial practice. The S.I. units in parentheses are provided for information only.NOTE 3: Because of trade practice the term “weight” is used in this test method instead of the technically correct term “mass”.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 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 This test method is suitable for research or for quality control to characterize TDI and MDI.5.2 This test method was developed to overcome problems with low-level acidity determinations that use glass electrodes in the presence of reagent alcohol solvents. Reagent alcohols contain acidic and basic species, which complicate the glass electrode methods at low levels of acidity.1.1 This test method measures the hydrolyzable chlorine content of monomeric, aromatic isocyanates used as polyurethane raw materials and expresses it as HCl acidity. The test method is applicable to toluene diisocyanate (TDI) and monomeric methylene di(phenylisocyanate), known as MDI. The main sources of hydrolyzable chlorine and, therefore, acidity in monomeric aromatic isocyanates are carbamyl chlorides, acid chlorides, and dissolved phosgene. All of these compounds react with alcohols and water to form hydrochloric acid.1.2 This test method applies only to monomeric isocyanates in which all of the acidity is derived from species that generate HCl on solvolysis.1.3 The values stated in SI units are to be regarded as the 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.NOTE 1: There is no known ISO equivalent to this standard.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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ASTM D765-87(2020) Standard Specification for Raw and Burnt Sienna Pigments Active 发布日期 :  1970-01-01 实施日期 : 

This specification establishes the properties and requirements for the pigments commercially known as raw sienna and burnt sienna in the dry and paste in oil forms. The dry pigments shall be sampled and tested as appropriate, and conform accordingly to composition requirements as to iron oxide, calcium compounds, moisture and other volatile matter, coarse particles (total residue retained on a No. 325 sieve), and organic colors. The pigments in paste in oil form shall conversely be tested and conform to composition requirements as to pigment, nonvolatile vehicle, moisture by distillation, and coarse particles (total residue retained on a No. 325 sieve). Both forms shall adhere to specified mass color, tint character, and tinting strength requirements as well.1.1 This specification covers the pigments commercially known as raw sienna and burnt sienna.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.

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5.1 These test methods are to be used for research or for quality control to characterize isocyanates used in polyurethane products.1.1 These test methods are used to measure the isocyanate content of aromatic isocyanates used as polyurethane raw materials.1.1.1 Test Method A—Unheated toluene-dibutylamine determines the toluene diisocyanate content, the amine equivalent and the isocyanate content of refined toluene-2,4-diisocyanate and toluene-2,6-diisocyanate, or mixtures of the two. Other isomers, if present, will be included in the determination. This test method is also applicable to other isocyanates of suitable reactivity and solubility.1.1.2 Test Method B—Heated toluene-dibutylamine determines the amine equivalent and the isocyanate content of crude or modified isocyanates derived from toluene diisocyanate, methylene di-(4-phenylisocyanate) and polymeric (methylene phenylisocyanate).1.1.3 Test Method C—Unheated trichlorobenzene-toluene-dibutylamine determines the amine equivalent and the isocyanate content of crude or modified isocyanates derived from toluene diisocyanate, methylene-di-(4-phenylisocyanate) and polymeric (methylene phenylisocyanate).1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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.NOTE 1: Method C of this test method is equivalent to Method B of ISO 14896.1.4 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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These test methods provide a means for determining whether waste glass is suitable for use as a raw material for glass manufacturing.1.1 These test methods give the various tests for assessing the compliance of glass recovered from wastes for use as a raw material for glass manufacturing.1.2 The test methods combine visual examinations with both chemical and physical tests. A flow chart of the testing sequence is included in this test method (see ).1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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. For hazard statements, see , , Section , and .

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This specification covers particulate glass (cullet material) recovered from waste destined for disposal, smaller than 6 mm intended for reuse as a raw material in the manufacture of glass containers. Flint glass cullet is a particulate glass material that contains no more than 0.1 weight % Fe2O3, or 0.0015 weight % Cr2O3, as determined by chemical analysis. The color mix for amber, flint, green and other color glass cullet shall conform to the prescribed mix.1.1 This specification covers particulate glass (cullet material, recovered from waste destined for disposal, smaller than 6 mm intended for reuse as a raw material in the manufacture of glass containers.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.2.1 Exception—The values given in parentheses are for information only.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.

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4.1 These test methods can be used for research or for quality control to characterize isocyanates used in polyurethane products.4.2 A general test method for specific gravity using a digital density meter, which applies to isocyanates as well as other liquids is published in Test Method D4052.1.1 These test methods determine the specific gravity of toluenediisocyanate, polymeric (methylene phenylisocyanate), and liquid methylene di(phenylisocyanate). These test methods also are applicable to many other liquids. (See Note 1.)1.1.1 Test Method A—Specific gravity by pycnometer, for high-accuracy determination.1.1.2 Test Method B—Specific gravity by hydrometer, for a less accurate, but rapid, determination.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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.NOTE 1: There is no known ISO equivalent to this standard.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 These test methods are suitable for research or for quality control to determine the isomer content of toluene diisocyanates.5.2 The isomer content of a toluene diisocyanate relates to its reactivity.1.1 These test methods measure the amount of toluene-2,6-diisocyanate (2,6-TDI) isomer or toluene–2,4–diisocyanate (2,4-TDI) isomer in mixtures of the 2,4- and 2,6-isomers of toluenediisocyanate (TDI). Two different test methods are provided to give accurate results over the broad range of isomer concentrations possible.1.1.1 Test Method A—Applicable to TDI samples containing 5 to 95 % of 2,6-TDI isomer (5 to 95 % 2,4-TDI isomer).1.1.2 Test Method B—Applicable to TDI samples containing 0 to 5 % of 2,6-TDI isomer (95 to 100 % 2,4-TDI isomer).NOTE 1: These test methods are equivalent to ISO 15064.1.2 The values stated in SI units are to be regarded as standard.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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