5.1 This guide describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a medical device.5.2 In the case of a brush part intended to clean a lumen, the force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a measurable parameter that can change over time and will decrease as the brush part loses integrity.5.3 In the case of a brush part intended to clean the external surface, the force required to move the brush across a surface and the pressure the brush exerts on that surface are measurable parameters that can change over time and will decrease as the brush part loses integrity.5.4 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs.1.1 This guide describes methods for assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing.1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276. In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part.1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the service life of the brush. This may be stated in terms of (1) a time period; (2) the number of uses; (3) inspection of the brush for wear and damage.1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part.1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, 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.

定价： 515元 / 折扣价： 438 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 646元 / 折扣价： 550 元 加购物车

This specification covers a group of common requirements that shall apply to carbon, alloy, and stainless steel fasteners or fastener materials, or both. These materials are intended for use at any temperature from cryogenic to the creep range. Requirements for the melting process and quality control procedures for ingot cast and strand cast products are detailed. Bars and fasteners shall be produced in accordance with the product specification. The chemical composition, as to heat and product analyses, shall conform to the limits of the product specification. Bars, fasteners, bolting materials, and specimen machined from fasteners shall meet the mechanical requirements which shall be determined by the following tests: (1) proof load test by mandrel/tension or compression methods, (2) cone proof load test, (3) impact test, and (4) hardness test. Assembly for the proof load and cone proof tests are illustrated. The depth of decarburization shall be determined by metallographic etching and if needed, microhardness testing.1.1 This specification covers a group of common requirements that shall apply to carbon, alloy, stainless steel, and nickel alloy bolting under any of the following ASTM Specifications (or under any other ASTM Specifications that invoke this specification or portions thereof):Title of Specifications ASTM DesignationAlloy-Steel and Stainless Steel Bolting for High Temperature or High Pressure Service and Other Special Purpose Applications A193/A193MCarbon Steel, Alloy Steel, and Stainless Steel Nuts for Bolts for High Pressure or High Temperature Service, or Both A194/A194MAlloy-Steel and Stainless Steel Bolting for Low- Temperature Service A320/A320MStainless and Alloy-Steel Turbine-Type Bolting Specially Heat Treated for High-Temperature Service A437/A437MHigh-Temperature Bolting, with Expansion Coefficients Comparable to Austenitic Stainless Steels A453/A453MAlloy-Steel Bolting for Special Applications A540/A540MPrecipitation-Hardening Bolting (UNS  N07718) for High Temperature Service A1014/A1014MHigh Strength Precipitation Hardening and Duplex Stainless Steel Bolting for Special Purpose Applications A1082/A1082M1.2 In case of conflict, the requirements of the individual product specification shall prevail over those of this specification.1.3 Fasteners are a wide-ranging classification that includes screws, bolts, nuts, washers, stud bolts, rivets, powder-actuated studs, staples, tacks, and pins. Bolting, which is composed of bolting materials, such as rods, bars, flats, and forgings, which are subsequently manufactured into bolting components, are a special sub-group of fasteners. Bolting materials and components have designated compositions and specific properties intended for applications in aggressive service where commercial generic fasteners may not be suitable or have insufficient fitness for purpose under certain conditions. These conditions include cryogenic or high temperature service, or excessive vibration, impact, or shock. To further address any other special service conditions where bolting is intended for use, additional requirements may be specified by mutual agreement between the purchaser and supplier.1.4 Supplementary requirements are provided for use at the option of the purchaser. The supplementary requirements only apply when specified individually by the purchaser in the purchase order or contract.1.5 This specification is expressed in both inch-pound units and in SI units. Unless the purchase order or contract specifies the applicable “M” specification designation (SI units) the inch-pound units shall apply. The values stated in either SI units or inch-pound units are to be regarded separately as standard. Within the text, the SI units are shown in brackets. 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 nonconformance with the specification.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： 646元 / 折扣价： 550 元 加购物车

定价： 646元 / 折扣价： 550 元 加购物车

定价： 515元 / 折扣价： 438 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

This specification covers tin-coated annealed copper wire intended for electrical and electronic applications where solderability is a requirement. The tin shall be electroplated for the coating and shall be commercially pure. The base metal shall be copper of such quality and purity that the finished product shall have properties and characteristics prescribed. Tensile strength and elongation, resistivity, dimensional measurements, continuity of coating, thickness of coating, and solderability test methods shall be performed to conform to the requirements specified.1.1 This specification covers tin-coated annealed copper wire intended for electrical and electronic applications where solderability is a requirement.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.1.2.1 Exceptions—The SI values for density, resistivity, and volume 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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of alginate. This guide can be used as an aid in the selection and characterization of the appropriate alginate for a particular application. This guide is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular alginate. It may have use in the regulation of these devices by appropriate authorities.4.2 The alginate covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use in tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application. Further guidance for immobilizing or encapsulating living cells or tissue in alginate gels can be found in Guide F2315.4.3 To ensure that the material supplied satisfies requirements for use in TEMPS, several general areas of characterization should be considered. These are: identity of alginate, physical and chemical characterization and testing, impurities profile, and performance-related tests.1.1 This guide covers the evaluation of alginates suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of alginates.1.3 As with any material, some characteristics of alginates 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 polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.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.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

4.1 The ASTM guidance manual, Form and Style for ASTM Standards,4 Section A21, requires a precision and bias statement in all ASTM test methods. Section A21.2.2 states:  Precision shall be estimated in accordance with the interlaboratory test program prescribed in Practice E691, Conducting an Interlaboratory Study to Determine the Precision of a Test Method, or by an interlaboratory test program that yields equivalent information, for example, a standard practice developed by an ASTM technical committee.4.2 Practice D2777, Section 1.1, states:  This practice establishes uniform standards for estimating and expressing the precision and bias of applicable test methods for Committee D19 on Water. Statements of precision and bias in test methods are required by the Form and Style for ASTM Standards, “Section A21. Precision and Bias (Mandatory).” In principle, all (ASTM Committee D19) test methods are covered by this practice.4.3 Practice D2777, Section 1.2, requires a task group proposing a new test method to carry out a collaborative study from which concentration limits, repeatability and reproducibility precision and bias statements are developed.4.3.1 This guide describes options for developing and optimizing chemical test methods for Committee D19, not implementation of a test method by a laboratory. Refer to Guide E2857 for procedures used in validating existing test methods for your laboratory.4.3.2 The collaborative study described in Practice D2777 is not the test method validation. The collaborative study verifies the new test method is reproducible among different laboratories, different instruments/apparatus, and different analysts.4.3.3 Practice D2777, Section 6.1, assumes the test method has already been optimized prior to conducting the collaborative study.4.4 Practice D2777, Section 4 (Summary of Practice), requires, a collaborative study only after the task group has assured itself that preliminary evaluation work is complete and the test method has been written in its final form.4.5 Practice D2777, Section 5.2 (), requires the collaborative test corroborates the test method write up (preliminary evaluation) within the limits of the test design.4.5.1 The assumption is that the collaborative study is a fair evaluation of the inter-laboratory variability when using the test method to analyze the matrices, and concentration ranges specified in the test method.4.6 Practice D2777, Section 6 (Preliminary Studies), requires considerable pilot work on a test method should precede the determination of precision and bias (collaborative study). This pilot work evaluates such variables as:4.6.1 Representative Sampling,4.6.2 Suitability of containers,4.6.3 Preservation requirements,4.6.4 Identification of interferences,4.6.5 Holding times (Practice D4841),4.6.6 Concentration range,4.6.7 Quantitation ranges,4.6.8 Concentration and preparation of reagents,4.6.9 Reagent standardization,4.6.10 Shelf life of reagents,4.6.11 Calibration,4.6.12 QC, and4.6.13 Sample size.4.7 Potentially significant factors are investigated in advance and are controlled in the written test method that is distributed for the collaborative test.4.8 Only after the proposed test method has been thoroughly tried and proved and reduced to unequivocal written form should a collaborative test be conducted.4.9 The Committee D19 test method is written in two steps:4.9.1 Step I—Single laboratory characterization or optimization (Practice D2777, Section 6.3.1.1).4.9.2 Step II—Collaborative study (Practice D2777, Section 6.3.1.2).4.10 This document is a guide to Committee D19 task groups developing chemical test methods.1.1 This guide identifies procedures for use in developing and optimizing new or modified Subcommitees D19.05 and D19.06 test methods intended for regulatory compliance reporting in EPA drinking water and wastewater programs. This guide may also be useful for developing test methods for emerging contaminants that may not yet have regulatory requirements.1.2 This guide also cites statistical procedures that are useful in the single laboratory characterization and optimization and in the inter-laboratory studies (ILSs).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 guide offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project’s many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.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： 646元 / 折扣价： 550 元 加购物车

定价： 0元 / 折扣价： 0 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车

定价： 515元 / 折扣价： 438 元 加购物车

4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and characterization of the appropriate hyaluronan for a particular application. This guide is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular hyaluronan. It may have use in the regulation of these devices by appropriate authorities.4.2 The hyaluronan covered by this guide may be gelled, cross-linked, extruded, or otherwise formulated into biomedical devices for use in tissue engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.4.3 To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These are: identity of hyaluronan, physical and chemical characterization and testing, impurities profile, and performance-related tests.1.1 This guide covers the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan.1.3 As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as cross-linking and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.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 requirements prior to use.

定价： 590元 / 折扣价： 502 元 加购物车

定价： 590元 / 折扣价： 502 元 加购物车