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定价： 819元 / 折扣价： 697 元 加购物车

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5.1 The AHP method allows you to generate a single measure of desirability for project/product/process alternatives with respect to multiple attributes (qualitative and quantitative). By contrast, life-cycle cost (Practice E917), net savings (Practice E1074), savings-to-investment ratio (Practice E964), internal rate-of-return (Practice E1057), and payback (Practice E1121) methods all require you to put a monetary value on benefits and costs in order to include them in a measure of project/product/process worth.5.2 Use AHP to evaluate a finite and generally small set of discrete and predetermined options or alternatives. Specific AHP applications are ranking and choosing among alternatives. For example, rank alternative building locations with AHP to see how they measure up to one another, or use AHP to choose among building materials to see which is best for your application.5.3 Use AHP if no single alternative exhibits the most preferred available value or performance for all attributes. This is often the result of an underlying trade-off relationship among attributes. An example is the trade-off between low desired energy costs and large glass window areas (which may raise heating and cooling costs while lowering lighting costs).5.4 Use AHP to evaluate alternatives whose attributes are not all measurable in the same units. Also use AHP when performance relative to some or all of the attributes is impractical, impossible, or too costly to measure. For example, while life-cycle costs are directly measured in monetary units, the number and size of offices are measured in other units, and the public image of a building may not be practically measurable in any unit. To help you choose among candidate buildings with these diverse attributes, use AHP to evaluate your alternatives.5.5 The AHP method is well-suited for application to a variety of sustainability-related topics. Guide E2432 states when applying the concept of sustainability, it is necessary to assess and balance three dissimilar yet interrelated general principles—environment, economic, and social—based on the best information available at the time the decision is made. Use AHP for pairwise comparisons among environmental attributes, among economic attributes, and among social attributes, and for establishing relative importance weights for each attribute and for each of the three general principles to which the attributes are attached. Use the AHP-established relative importance weights to select the preferred project/product/process from among the competing alternatives.5.6 Potential users of AHP include architects, developers, owners, or lessors of buildings, real estate professionals (commercial and residential), facility managers, building material manufacturers, equipment manufacturers, product and process engineers, life cycle assessment experts, and agencies managing building portfolios.1.1 This practice presents a procedure for calculating and interpreting AHP scores of a project’s/product’s/process’ total overall desirability when making capital investment decisions.3 Projects include design, construction, operation, and disposal of commercial and residential buildings and other engineered structures.4 Products include materials, components, systems, and equipment.5 Processes include procurement, materials management, work flow, fabrication and assembly, quality control, and services.1.2 In addition to monetary benefits and costs, the procedure allows for the consideration of characteristics or attributes which decision makers regard as important, but which are not readily expressed in monetary terms. Examples of such attributes that pertain to the selection among project/product/process alternatives are: a construction projects’s building alternatives whose nonmonetary attributes are location/accessibility, site security, maintainability, quality of the sound and visual environment, and image to the public and occupants; building products based on their economic and environmental performance; and sustainability-related issues for key construction processes that address environmental needs, while considering project safety, cost, and schedule.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The test method is designed to demonstrate that all accessible surfaces and internal recesses or lumina of previously cleaned, reusable medical devices can be rendered free of recoverable microorganisms when processed in a specified sterilizer cycle.5.2 Surviving spores are recovered by swabbing, brushing, or irrigating with an elution fluid. Recovery methods may be enhanced by mechanical action, sonication, and repeated flushing with elution fluid.NOTE 1: The spore inoculation technique described in this test method is only one of the available procedures for testing the sterilization of devices. Spores on paper strips (biological indocators) are a traditional tool used to develop and monitor sterilization cycles and are also appropriate for the evaluation of sterilization of medical devices.51.1 This test method covers a reproducible procedure for testing processes used to sterilize reusable medical devices (instruments). This test method is not designed to validate a sterilization process, but tests an established sterilization cycle or process. It is a practical test of the effectiveness of a sterilization process applied to reusable medical devices. Bacterial spores more resistant to the test sterilant than the natural bioburden of the instrument are used as the test organisms. Commercially available liquid suspensions of bacterial spores are used to inoculate the instruments.1.2 This test method is intended for reusable medical devices cleaned in accordance with the device manufacturer's instructions and prepared for sterilization in accordance with the instructions for the sterilization process being used.1.3 This test method assumes that cleaned, reusable medical devices will be free of visible soil but may have remaining adherent bioburden. A worst-case bioburden can be represented by suspensions of bacterial endospores, which are commercially available for monitoring chemical or physical sterilization processes. These endospores should have a verifiable resistance (D value) to the specific process and sterilant being evaluated.21.4 It is impractical to test for the sterility of some devices by immersion in growth medium because of their complexity, size, and availability (for long-term incubation) or adverse effects on the devices from long-term immersion. Therefore, elution, rinsing, or swabbing techniques are used to recover test organisms from inoculated devices.1.5 A recovery control will be included by inoculation of a test device and use of the elution methods without applying the sterilization process being tested. A minimal recovery of 106 colony-forming unit (CFU)/mL per device is required for the recovery control.1.6 Results of the recovery control and process test cycle are compared to determine the effectiveness of the sterilization process.1.7 Results of the recovery control and applied inoculum are compared to determine the recovery efficiency, if desired.1.8 The procedure should reveal that tested devices are free of recoverable microorganisms when five or more consecutive tests are conducted.1.9 A knowledge of microbiological techniques is required to conduct these procedures.1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.11 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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1.1 The requirements in this document are for part manufacturers using additive manufacturing techniques and are independent of the used material and manufacturing method.1.2 This document specifies criteria for AM relevant processes as well as quality-relevant characteristics and factors along the additive system operations and defines activities and sequences within an additive manufacturing production site.1.3 This document is applicable to the additive manufacturing technologies defined in ISO/ASTM 52900 and defines quality assurance measures along the manufacturing process.1.4 Environment, health and safety aspects are not covered comprehensively in this document. The corresponding content is addressed in the equipment manufacturer guidelines and ISO/ASTM 52931, ISO 27548,2 ISO/ASTM 52933, and ISO/ASTM 52938-1.31.5 This document provides requirements that are additional to those provided by a quality management system (such as, ISO 9001, ISO/TS 22163, ISO 19443, EN 9100, ISO 13485, IATF 16949). Additionally, this document can be used to establish quality management system relevant content that is specific to AM-technology.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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5.1 This test method is designed to evaluate the effectiveness of cleaning reusable medical instruments using a specified cleaning process.5.2 This test method may be used to determine the effectiveness of cleaning processes of recesses, hinged sites, lumina, or other difficult-to-reprocess areas of reusable medical instruments.5.3 This test method may also be used to verify the claims for any portion of the cleaning cycle.5.4 The recovery of surviving microorganisms may be accomplished using swabbing, rinsing, or total immersion of instruments.5.5 The efficacy of the elution methods or loss of the applied inoculum may be assessed by recovery of target organisms from control instruments that have not been subjected to the cleaning process.1.1 This test method is written principally for large medical instruments or instruments with internal channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical instruments.1.2 This test method describes a procedure for testing the efficacy of a cleaning process for reusable medical instruments artificially contaminated with mixtures of microorganisms and simulated soil.1.3 The test method utilizes bacterial spores as tracers for foreign materials and quantifies their removal as a means of determining the efficacy of a cleaning process.1.4 The test method is designed for use by manufacturers of medical instruments and devices. However, it may also be employed by other individuals who have a knowledge of the instruments, techniques and access to appropriate facilities.1.5 Worst-case conditions can be represented by exaggerating a specific test parameter or otherwise intentionally simulating an extreme condition such as performing the test without cleaning solutions or utilizing instruments which are not new.1.6 The test procedure is devised to determine the efficacy of a cleaning process as applied to a particular instrument or group of instruments by simulating actual use situations.1.7 The test procedure may be performed on test instruments using a complete cleaning cycle or be limited to particular phases of the cycle such as precleaning, manual cleaning, automated cleaning, or rinsing.1.8 The test procedure is normally performed on a number of external and internal sites, but it may be restricted to one particular site on the instrument.1.9 A knowledge of microbiological and aseptic techniques and familiarity with the instruments is required to conduct these procedures.NOTE 1: Because contamination of the surfaces of instruments may occur as a result of rinsing with tap water, bacteria-free water should be used for all rinsing when a water rinse step is part of the cleaning directions.NOTE 2: Test methods to determine the effectiveness of cleaning medical instruments has only recently been actively debated, and research efforts are in their infancy. Because published experimental results are scarce, it is premature to dictate experimental reagents, conditions or acceptance criteria.NOTE 3: The total elimination of the target organisms is not the goal of cleaning. Therefore, there will almost always be a number of microorganisms surviving on the test instruments unless one of the solutions or processes disinfects or sterilizes the test instrument. The results of various clinical and laboratory tests suggest that cleaning processes alone can produce a 102 to 104 log10 reduction in bioburden. The exact reduction will depend upon the precise experimental conditions. The criteria for judging cleanliness should be determined and recorded before initiation of the test procedure.NOTE 4: This test protocol employs target spores as indicators or tracers for foreign materials and monitors their removal by the cleaning process. It is certainly possible that other particulate target materials, such as microbeads (latex beads) could be used in place of microbes. These alternate approaches would be more practical in those circumstances where microbiological expertise is limited.1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.11 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 and health practices and determine the applicability of regulatory limitations prior to use.

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5.1 The purpose of these test methods is to define a procedure for evaluating the capability and effectiveness of cleaning agents to remove residues of a compound/product from surrogate surfaces (that is, coupons or beakers) of Materials of Construction. This test method also provides a procedure for determining the compatibility of cleaning agents with the Material of Construction prior to starting tests. Based on the outcome of the testing, suitable cleaning agents may be selected for further cleaning process development (see Guide D6361/D6361M).5.2 The potential critical cleaning parameters related to the cleaning agent(s) under study may also be examined using these tests. Potentially critical cleaning parameters include cleaning agent concentration, temperature, time, pH, foaming, type and strength of ultrasonic energy or agitation (if used), and others. These parameters may be varied (for example, using Design of Experiments) to determine their potential optimal settings for actual use.1.1 This test method covers a procedure for evaluating the effectiveness and capability of cleaning agents to remove contamination to the desired level. This includes removing drug residues from manufacturing equipment and residues from medical devices (Guide E3106), as well as systems for oxygen service.1.2 The test coupons/beakers described in this standard provide a representative surface to which contamination can be applied and tested for the ability of a cleaning agent to remove it.1.3 This test method is a laboratory scale approximation and the actual effectiveness of a particular cleaning agent depends upon the method (temperature, agitation, concentration, etc.) in which it is used and the characteristics of the article being cleaned, such as size, shape, and material. Final evaluation of the cleaning agent should include testing of actual products and cleaning processes.1.4 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units 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 safety of each compound on a case-by-case basis.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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