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4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems 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.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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4.1 Calibration is a fundamental part of making measurements and its effect on the quality of measurement data is significant. Thus, sufficient attention must be given to calibration when it is established for a measurement method so that the data produced will be acceptable. The use of an inappropriate calibration standard, inadequate instructions for calibration, and poor documentation of the calibration process are examples of circumstances that can adversely affect the validity of a calibration. Thus, the calibration process must conform to criteria established to ensure the validity of calibration results and any associated measurement data. Such criteria are given in Guide C1009, in which calibration is identified as a component of laboratory quality assurance (see Fig. 1). This guide expands upon those criteria to provide more comprehensive guidance for establishing calibration.FIG. 1 Quality Assurance of Analytical Laboratory Data4.2 The manner of calibration and other technical requirements for calibrating a measurement method are usually established when a method is first introduced into a laboratory, which may be through validation and qualification as defined by Guide C1068 (see Fig. 1). However, calibration involves more than the technical aspects of the calibration process. The other dimension of the process is the operational requirements that are necessary to ensure that calibration results are valid and that they are documented and verifiable should their integrity be questioned. The provisions of this guide provide those operational requirements and should be considered whenever calibration is planned and established.1.1 This guide provides the basis for establishing calibration for a measurement method typically used in an analytical chemistry laboratory analyzing nuclear materials. Guidance is included for such activities as preparing a calibration procedure, selecting a calibration standard, controlling calibrated equipment, and documenting calibration. The guide is generic and any required technical information specific for a given method must be obtained from other sources.1.2 The guidance information is provided in the following sections:  SectionGeneral Considerations 5Calibration Procedure 6Calibration Standard 7Control of Calibrated Equipment 8Documentation 9Keywords 101.3 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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This guide describes methods for determining the key attributes of hydrogels used in regenerative medicine (that is, their biological properties, kinetics of formation, degradation and agent release, physical and chemical stability and mass transport capabilities). See Table 1.1.1 Hydrogels are water-swollen polymeric networks that retain water within the spaces between the macromolecules; and maintain the structural integrity of a solid due to the presence of cross-links (1-3). They are mainly used in regenerative medicine as matrix substitutes, delivery vehicles for drugs and/or biologics, and environments for cell culture. In these applications, hydrogel efficacy may depend on the ability to: support the permeation of dissolved gases, nutrients and bioactive materials; sustain cell growth and migration; degrade; release drugs and/or biologics at an appropriate rate; and maintain their shape.1.2 Hydrogels used in regenerative medicine can be composed of naturally derived polymers (for example, alginate, chitosan, collagen (4, 5)), synthetically derived polymers (for example, polyethylene glycol (PEG), polyvinyl alcohol (PVA) (4, 5)) or a combination of both (for example, PVA with chitosan or gelatin (6)). In clinical use, they can be injected or implanted into the body with or without the addition of drugs and/or biologics (7).1.3 This guide provides an overview of test methods suitable for characterizing hydrogels used in regenerative medicine. Specifically, this guide describes methods to assess hydrogel biological properties, kinetics of formation, degradation and agent release, physical and chemical stability and mass transport capabilities are discussed.1.4 The test methods described use hydrated samples with one exception: determining the water content of hydrogels requires samples to be dried. It is generally recommended that hydrogels that have been dried for this purpose are not rehydrated for further testing. This recommendation is due to the high probability that, for most hydrogel systems, the drying-rehydration process can be detrimental with possible alterations in structure.1.5 This guide does not consider evaluation of the microstructure of hydrogels (for example, matrix morphology, macromolecule network structure and chain conformation).1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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 and health practices and determine the applicability of regulatory limitations prior to use.

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This specification establishes testing procedures and critical characteristics of 0.68 caliber paintballs which help define whether a paintball is suitable for use in the sport of paintball. Furthermore, the specification establishes minimum warning and package labeling to help ensure that the paintballs are used in a safe manner and that the risk of injury is reduced. Tests shall be performed to conform with the requirements specified in accordance with the following test methods: paintball compatibility with polycarbonate and paintball impact breakage test.1.1 This specification establishes testing procedures and critical characteristics for projectiles, which define whether they are suitable for use in the sport of paintball. Furthermore, the specification establishes minimum warning and package labeling requirements to help ensure that the paintballs are used in a safe manner and that the risk of injury is reduced.1.2 This specification does not cover non-recreational paintballs, for example, those used by law enforcement, scientific, military, or theatrical entities.1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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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This specification covers woven cotton fabrics saturated with either asphalt or coal-tar intended for use with asphalt based plying cement (such as mopping asphalts or appropriate solvent bearing asphaltic compounds), coal-tar based plying cement (such as coal-tar pitch or other appropriate solvent bearing coal-tar compounds), or appropriate solvent bearing bituminous materials in the construction of roofing and waterproofing systems. The dry cotton fabric shall be thoroughly and uniformly saturated with bitumen by passing the fabric through the saturant or by spraying with saturant, calendering in the presence of heat, and then cooling before winding on a core. Products shall be sampled, tested, and adhere accordingly to specified physical (breaking load in both the warp and fill directions, and pliability), and dimensional (mass, width, thread count, moisture, and ash content) property requirements. The finished product shall not crack nor be so sticky as to cause tearing or other damage upon being unrolled at a given temperature.1.1 This specification covers woven cotton fabrics saturated with either asphalt or coal-tar pitch intended to be used with asphalts conforming to Specifications D312/D312M or D449/D449M, coal-tar pitches conforming to Specification D450/D450M, or appropriate solvent bearing bituminous materials in the construction of roofing and waterproofing systems.1.1.1 Asphalt-saturated cotton fabric shall be used with asphalt base plying cement; typical ones are mopping asphalts conforming to Specifications D312/D312M or D449/D449M or appropriate solvent bearing asphaltic compounds.1.1.2 Coal-tar-saturated cotton fabric shall be used with coal-tar based plying cements; a typical one is coal-tar pitch conforming to Specification D450/D450M or appropriate solvent bearing coal-tar compounds.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.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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5.1 Self-adhesion is a primary initial property since it affects layer-to-layer bonding. The integrity of the bond can significantly affect the electrical and physical performance of the insulation system. Therefore, the degree of self-adhesion is directly related to apparatus performance.5.2 A high degree of self-adhesion is desirable for most electrical applications. In this test, a short unwinding length indicates a high degree of self-adhesion.5.3 This test method has been found useful as a quality control test for lot acceptance.1.1 These test methods cover tests for bondable silicone rubber tapes which form a sealed structure either with the application of heat (and pressure if needed) or by the process of auto-adhesion (self-fusing).1.2 These test methods appear in the following sections:     Test Method Section        Adhesion 3 – 10     Bond Strength 11 – 18     Dielectric Breakdown Voltage 19 – 26     Hardness 41     Length 33 and 34     Thickness 27 – 32     Width 36 – 401.3 Units—The values stated in SI units are the standard. The inch-pound units in parentheses are for information only. 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.1.4 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. For a specific hazard statement see 23.1.1.1.5 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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This specification covers fiber or fabric reinforced nonvulcanized white polymeric sheet made from polyisobutylene (PIB) intended for use as a single-ply roof membrane exposed to the weather. In-place roof systems design criteria such as fire resistance, field seaming strength, impact/puncture resistance, material compatibility, and uplift resistance, among others, are beyond the scope of this specification. Backed sheets shall conform to the following physical properties: thickness; breaking strength; elongation; tearing strength; low temperature bend; linear dimensional change; fabric adhesion; hydrostatic resistance; ozone resistance; and weather resistance. On the other hand, coating portions on the weather side of the sheet containing no backing shall adhere to the following physical properties: tensile strength; elongation; tear resistance; ozone resistance; and water absorption.1.1 This specification covers white reinforced non-vulcanized polymeric sheet made from polyisobutylene (PIB) intended for use as a single-ply roof membrane exposed to the weather. The sheet shall be reinforced with fiber or fabric.1.1.1 The polymers used in these sheets have thermoplastic characteristics at time of installation.1.2 The tests and property limits used to characterize these sheets are minimum values.1.2.1 In-place roof systems design criteria such as fire resistance, field seaming strength, impact/puncture resistance, material compatibility, and uplift resistance, among others, are factors that must be considered, but are beyond the scope of this specification.The following precautionary caveat pertains to the test methods portion only, Section , of this specification: 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 requirements prior to use.

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This specification designates woods to be used as panels in weathering tests of coatings such as solvent-borne or water-borne paints. Different wood species shall be considered for testing due to their wide variations in the anatomy and density. Wood species materials for test panels include western red cedar, white pine and Ponderosa pine, southern pine, redwood, and Douglas fir. Wood panel characteristics such as weight per volume, wood character, panel thickness, surface smoothness, relative humidity, and growth rings density shall be in accordance with the specification.1.1 This specification designates woods for weathering tests of exterior solvent-borne or water-borne paints and other materials of similar purpose. Such tests may include either outdoor exposure tests or accelerated laboratory tests. It is the purpose of this specification to minimize the influence of variation of wood of a given species on test results.1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.

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5.1 This test method measures a lubricant's ability to protect hypoid final drive axles from abrasive wear, adhesive wear, plastic deformation, and surface fatigue when subjected to low-speed, high-torque conditions. Lack of protection can lead to premature gear or bearing failure, or both.5.2 This test method is used, or referred to, in specifications and classifications of rear-axle gear lubricants such as:5.2.1 Specification D7450.5.2.2 American Petroleum Institute (API) Publication 1560.5.2.3 SAE J308.5.2.4 SAE J2360.1.1 This test method, commonly referred to as the L-37-1 test, describes a test procedure for evaluating the load-carrying capacity, wear performance, and extreme pressure properties of a gear lubricant in a hypoid axle under conditions of low-speed, high-torque operation.31.2 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 Exceptions—Where there is no direct SI equivalent such as National Pipe threads/diameters, tubing size, or where there is a sole source supply equipment specification.1.2.1.1 The drawing in Annex A6 is in inch-pound units.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. Specific warning statements are provided in 7.2 and 10.1.1.4 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 A major factor affecting the life of insulating materials is thermal degradation. It is possible that other factors, such as moisture and vibration, will cause failures after the material has been weakened by thermal degradation.5.2 Electrical insulation is effective in electrical equipment only as long as it retains its physical and electrical integrity. The following are potential indicators of thermal degradation: weight change, porosity, crazing, and generally a reduction in flexibility. Thermal degradation is usually accompanied by an ultimate reduction in dielectric breakdown.5.3 This test method is useful in determining the thermal endurance of coating powders applied over a copper or aluminum substrate material.1.1 This test method provides a procedure for evaluating thermal endurance of coating powders by determining the length of aging time at selected elevated temperatures required to achieve dielectric breakdown at room temperature at a pre-determined proof voltage. Thermal endurance is expressed in terms of a temperature index.1.2 This test method is applicable to insulating powders used over a substrate material of copper or aluminum.1.3 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, each system shall be used independently of the other. Combining values from the two systems is likely to result in non-conformance with 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. Specific precautionary statements are given in Section 7.1.5 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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This specification covers warnings used on paintball marker accessories used in the sport of paintball. It states that all of the paintball marker accessories for use in the sport of paintball shall include a cautionary statement which prominently and durably conveys certain information on the instruction sheet, the packaging, or the product itself, or a combination thereof.1.1 This specification covers warnings used on paintball marker accessories used in the sport of paintball. The warnings contained in this standard are intended for products that do not have individual ASTM standards which contain product specific warnings.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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5.1 A major factor affecting the life of insulating materials is thermal degradation. It is possible that other factors, such as moisture and vibration, will cause failures after the material has been weakened by thermal degradation.5.2 Electrical insulation is effective in electrical equipment only as long as it retains its physical and electrical integrity. The following are potential indicators of thermal degradation: weight change, porosity, crazing, and generally a reduction in flexibility. Thermal degradation is usually accompanied by an ultimate reduction in dielectric breakdown.5.3 This test method is useful in determining the thermal endurance of coating powders applied over a steel substrate material.1.1 This test method provides a procedure for evaluating thermal endurance of coating powders by determining the length of aging time at selected elevated temperatures required to achieve dielectric breakdown at room temperature at a pre-determined proof voltage. Thermal endurance is expressed in terms of a temperature index.1.2 This test method is applicable to insulating powders used over a substrate material of steel.1.3 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, each system shall be used independently of the other. Combining values from the two systems is likely to result in non-conformance with 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. Specific precautionary statements are given in Section 7.1.5 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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This specification defines the masses to be used when testing rescue systems and components. The masses represent personnel and equipment that may be attached to a rescue system or components. However, the masses do not represent any particular type or kind of rescuer or equipment. The masses shall be classified as follows: Type I; Type II; Type III; Type IV; and Type V.1.1 This specification defines the masses to be used when testing rescue systems and components.1.2 The masses represent personnel and equipment that may be attached to a rescue system or components. However, the masses do not represent any particular type or kind of rescuer or equipment.1.2.1 The masses chosen have been used in the past or are in current use in testing of rescue systems and components. Limiting testing to the masses listed in this specification allows meaningful comparisons between past, current, and future test results.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 The user of this specification shall determine which mass(es) represent(s) the personnel and equipment attached to the system or component under test.1.5 For the purposes of this specification, mass and weight are synonymous when the object(s) representing the mass(es) are weighed in air anywhere on Earth.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 requirements prior to use.

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This specification covers the sampling, testing, and physical requirements of oxidized petroleum asphalt, which when applied in a sufficient thickness over a suitable subgrade and covered with a suitable cover material, will provide a satisfactory waterproof membrane for use as a canal, ditch, and pond lining. The asphalt shall not foam when heated are a specified temperature, when tested using appropriate methods, shall conform accordingly to the following properties: softening point (ring and ball); penetration points; ductility; flash point (Cleveland open cup); solubility in trichloroethylene; and loss in heating.1.1 This specification covers an oxidized petroleum asphalt which, when applied in a sufficient thickness over a suitable subgrade and covered with a suitable cover material, will provide a satisfactory waterproof membrane for use as a canal, ditch, and pond lining.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 should be used independently of the other. Combining values in any way may result in nonconformance with the 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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4.1 Testing machines that apply and measure displacement are used in many industries. They may be used in research laboratories to determine material properties, and in production lines to qualify products for shipment. The displacement measuring devices integral to the testing machines may be used for measurement of crosshead or actuator displacement over a defined range of operation. The accuracy of the displacement value shall be traceable to the National Institute of Standards and Technology (NIST) or another recognized National Laboratory. Practices E2309 provides a procedure to verify these machines and systems, in order that the measured displacement values may be traceable. A key element to having traceability is that the devices used in the verification produce known displacement characteristics, and have been calibrated in accordance with adequate calibration standards.1.1 These practices cover procedures and requirements for the calibration and verification of displacement measuring systems by means of standard calibration devices for static and quasi-static testing machines. This practice is not intended to be complete purchase specifications for testing machines or displacement measuring systems. Displacement measuring systems are not intended to be used for the determination of strain. See Practice E83.1.2 These procedures apply to the verification of the displacement measuring systems associated with the testing machine, such as a scale, dial, marked or unmarked recorder chart, digital display, etc. In all cases the buyer/owner/user must designate the displacement-measuring system(s) to be verified.1.3 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.1.4 Displacement values indicated on displays/printouts of testing machine data systems—be they instantaneous, delayed, stored, or retransmitted—which are within the Classification criteria listed in Table 1, comply with Practices E2309/E2309M.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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