5.1 The propensity of a material to stimulate delayed contact hypersensitivity must be assessed before clinical application of devices containing this material. Delayed hypersensitivity may occur anywhere in the body. Systemic delayed hypersensitivity may have a complex set of reactions and consequences depending on the actual tissue/organ site of reaction. Although the reactions are seldom life-threatening, severe tissue and organ damage my result over time. Skin is the usual test site to determine the propensity of a material to cause delayed hypersensitivity.5.2 The standard historical test methods have involved the use of guinea pigs with a cutaneous application and observation of the reaction site. The use of the murine local lymph node assay results in a numerical quantitation of stimulation, rather than subjective evaluation and could be used to determine dose responses.5.3 This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.1.1 This practice provides a methodology to use a combination of in vivio and in situ procedures for the evaluation of delayed contact hypersensitivity reactions.1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. This practice may be used for testing metals, with the exception of nickel-containing metals, unless the unique physicochemical properties of the materials may interfere with the ability of LLNA to detect sensitizing substances.1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation in the lymph nodes draining the site of test article administration on the ears of mice.1.4 The LLNA has been validated only for low-molecular-weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates.1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply a single source. Appropriate materials and reagents may be obtained from many commercial supply houses.1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.9 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 design of a controlled temperature bath will determine what thermometers can be calibrated and to what extent an isothermal condition is achieved. The lack of thermal stability and uniformity of the bath are sources of error that contribute to the overall calibration uncertainty.5.2 This guide describes a procedure for determining the effective working space for a controlled temperature fluid bath.5.3 This guide describes a procedure for determining the thermal stability within a controlled temperature fluid bath. Overall thermal stability is composed of the bath performance as specified by the manufacturer of the bath equipment and as a component of calibration uncertainty.5.4 This guide describes a procedure for determining the temperature uniformity of the working space of the controlled temperature fluid bath.1.1 This guide is intended for use with controlled temperature comparison baths that contain test fluids and operate within the temperature range of –100 °C to 550 °C.1.2 This guide describes the essential features of controlled temperature fluid baths used for the purpose of thermometer calibration by the comparison method.1.3 This guide does not address the details on the design and construction of controlled-temperature fluid baths.1.4 This guide describes a method to define the working space of a bath and evaluate the temperature variations within this space. Ideally, the working space will be as close as possible to isothermal.1.5 This guide does not address fixed point baths, ice point baths, or vapor baths.1.6 This guide does not address fluidized powder baths.1.7 This guide does not address baths that are programmed to change temperature.1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.9 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.1.10 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 procedure has been designed to evaluate handwash products using a palmar surface only contamination method. This method is an alternative contamination procedure to that listed in Test Method E1174. The current contamination procedure in Test Method E1174 describes a standardized procedure for contaminating the entire hand, palmar surface and back, directly using a marker organism. The contamination procedure in Test Method E1174 does not necessarily represent real world hand contamination. During routine activities it is only the palmar surface, comprising palms, fingers, and finger pads of the hands that becomes contaminated by contact with transient microorganisms. These microorganisms can then be transferred to food or objects. Methods to measure the amount of microorganisms transferred to food or objects can be found in Fischler et al5 and Fuls et al6 and will be developed into a future ASTM standard.1.1 This test method covers the determination of the effectiveness of antimicrobial handwashing agents for the reduction of transient microbial flora when used in a handwashing procedure.1.2 A knowledge of microbiological techniques is required for these procedures.1.3 This test method may be used to evaluate topical antimicrobial handwash formulations.1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.21.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and SI units follow in parentheses.1.6 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 limitations prior to use. For more specific precautionary statements see 8.5.

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5.1 The effectiveness of antimicrobial agents incorporated into disinfectants, sanitizers, and antiseptics is measured by their ability to kill microorganisms within a specified contact time. Hence, accurate determination of antimicrobial effectiveness requires complete and immediate inactivation (neutralization) of the antimicrobial agent. Inefficient or incomplete neutralization will permit killing or inactivation of microorganisms to continue beyond the experimental exposure time, resulting in an overestimation of antimicrobial activity.5.2 The neutralization methods commonly used in antimicrobial effectiveness evaluations are chemical inactivation, dilution, and filtration. All critical parameters of an antimicrobial effectiveness evaluation—for example, media, equipment, microorganism(s), and temperature of solutions—must be duplicated in the performance of selected neutralization procedure.5.3 The neutralization evaluation must include at least three replications (five replications in Section 9) so that a statistical analysis of the microbial recovery data can be performed. The number of replicates used in the evaluation depends on the statistical significance required for the expected results, the variability encountered in the data, and the relative effectiveness of the neutralization procedure.5.4 A limitation of these evaluation procedures is that they use microorganisms that have not been exposed to an antimicrobial agent. Under experimental conditions, cells exposed to neutralization procedures are likely to be damaged to different degrees by the antimicrobial agent. Sublethal injury may be a factor in recovery, and the effect of the neutralization procedure on recovery of injured organisms should be examined. This method is not intended to assess recovery of injured organisms.NOTE 3: Ideally, all microorganisms used in the antimicrobial effectiveness evaluation should be tested in the neutralization assay. However, representative organisms may be selected for testing, as judged appropriate by the investigator. The investigator is cautioned that failure to identify neutralizer efficacy and toxicity for all microorganisms could result in biased microbial reductions in an antimicrobial effectiveness evaluation. Also, for a study testing multiple antimicrobial formulations, and in which samples will contain multiple species of microorganisms (for example, skin flora) that are exposed to the formulations, a single procedure and/or combination of agents suitable for neutralizing the antimicrobial activities of the multiple formulations must be used for testing.1.1 These test procedures are used to determine the effectiveness of methodologies procedures and materials intended for inactivating (neutralizing, quenching) the microbicidal properties of antimicrobial agents; to ensure that no components of the neutralizing procedures and materials, themselves, exert an inhibitory effect on microorganisms targeted for recovery; and to demonstrate that the antimicrobial chemistry tested is microbicidal.1.2 Knowledge of microbiological and statistical techniques is required for these procedures.NOTE 1: These methods are not suitable when testing the virucidal activity of microbicides (see Test Method E1482).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 plastic Petri plate (carrier) provides a closed system for enumeration and easy application of a pre-saturated or impregnated antimicrobial towelette by an analyst.5.2 Aliquoting of sterile 5 % non-heat-inactivated fetal bovine serum (five 10 µL spots) onto soiled carriers and inoculation of final test suspension onto treated carriers (five 10 µL spots) is conducted using a template and a positive displacement pipette, thereby ensuring a precise inoculum level and uniform distribution of soil and final test suspension.5.3 A single towelette is tested per 2-carrier set, eliminating the likelihood of cross contamination between carriers.5.4 The corkscrew-patterned circular motion of the product application (wipe outside to inside, wipe inside to outside using the wiping template; see Annex A3 – Annex A6) ensures uniform coverage and contact of disinfectant with the inoculated surface.5.5 The addition of neutralizer to the treated carriers at the end of the contact time results in neutralization of the test substance. This standard test method provides a procedure for performing neutralization verification to confirm that the microbicidal, microbistatic, or both types of activity of a test substance has been reduced by 50 % at the end of the contact time (see Annex A1 for neutralization verification procedure).5.6 The design of this standard test method minimizes any loss of viable organisms through carrier wash-off.5.7 It is optional to adjust (dilution in PBS) the inoculum to achieve desired control counts of 5.0 log10 CFU/carrier to 6.5 log10 CFU/carrier.5.8 Include, where applicable, comparisons of the test to other similar procedures such as Practices E1054 and E2362.1.1 This test method quantitatively determines the effectiveness of various sizes of antimicrobial towelettes in treating hard, non-porous surfaces against Pseudomonas aeruginosa and Staphylococcus aureus.1.2 This test method may be used to evaluate towelettes for antimicrobial efficacy against additional microorganisms (with necessary modifications).1.2.1 This test method does not differentiate between chemical inactivation of the test microbe and mechanical removal of inoculum from a surface; rather, product efficacy is considered a combination of both attributes of a towelette-based formulation.1.3 This test method involves the use of hazardous materials, chemicals, and infectious microorganisms and therefore should be performed only by those trained in microbiological techniques in facilities designed and equipped for work with infectious agents at the appropriate biosafety level, a BSL-2 or higher laboratory; specifications provided in the “Biosafety for Biomedical and Microbiological Laboratories” (BMBL), 6th edition (BMBL).1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP Standards—For example, 40 CFR, Part 160 of FIFRA) are required and to follow them when appropriate.1.5 Strict adherence to the protocol is necessary for the validity of the test results.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, 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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4.1 Energy conservation is being addressed more often on existing and historically significant buildings constructed with solid exterior mass masonry walls. Without proper evaluation, changes to the thermal and moisture properties of the exterior walls could have serious negative impacts on the existing masonry, new or existing wall components, and building operations.4.2 A thorough understanding of the original construction and subsequent alterations, condition of materials, properties, initial moisture content, water and air leakage potential, and building operations are necessary before undertaking the addition of interior insulation, air barrier, vapor retarder, or other changes to thermal or vapor resistance of the wall.4.3 Degradation of the existing masonry along with moisture related problematic conditions and indoor air quality issues could develop if alterations are undertaken in an improper manner to the exterior wall assembly.1.1 This guide addresses the evaluation of existing mass masonry walls for the potential addition of interior insulation and continuous air barrier or vapor retarder or other changes to the thermal and moisture management properties of the wall.1.2 This guide describes methods for evaluating moisture accumulation related problems specific to mass masonry walls. This guide does not apply to walls that include provisions to manage bulk water through internal drainage, flashings, or other measures other than the moisture storage capacity of the wall.1.3 This guide describes analysis, design, and specification of materials with the required thermal, air, and vapor resistance to improve the energy performance of an existing mass masonry wall, but that would not create problematic conditions to the masonry units or within the masonry wall or interior of the building.1.4 This guide applies to walls of masonry construction meeting the requirements of a “mass masonry wall” as defined herein. This guide does not apply to masonry walls that, by design, are intended to manage water as a barrier wall system or drainage wall system.1.5 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.1.6 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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4.1 This guide presents some methodologies to predict the forces required to bring a disabled ship under control within the available limits of the waterway, taking into account local influences of wind and sea conditions. Presented are methodologies to determine the control forces that an escort vessel can reasonably be expected to impose on a disabled ship, taking into account the design of the ship, transit speed, winds, currents, and sea conditions. In some instances, this guide presents formulae that can be used directly; in other instances, in which the interaction of various factors is more complicated, it presents analytic processes that can be used in developing computer simulations.4.2 Unlike the more traditional work of berthing assistance in sheltered harbors or pulling a “dead ship” on the end of a long towline, the escorting mission assumes that the disabled ship will be at transit speed at the time of failure, and that it could be in exposed waters subject to wind, current, and sea conditions.4.3 The navigational constraints of the channel or waterway might restrict the available maneuvering area within which the disabled ship must be brought under control before it runs aground or collides with fixed objects in the waterway (see allision).4.4 The escort mission requires escort vessel(s) that are capable of responding in timely fashion and that can safely apply substantial control forces to the disabled ship. This entails evaluation of the escort vessel's horsepower, steering and retarding forces at various speeds, maneuverability, stability, and outfitting (towing gear, fendering, and so forth). This guide can be used in developing escort plans for selecting suitable escort vessel(s) for specific ships in specific waterways.4.5 The methodologies and processes outlined in this guide are for performance-based analyses of escort scenarios. This means that the acceptability of a vessel (or combination of vessels) for escorting is based upon the ability to control the disabled ship in accordance with specified performance criteria. This guide addresses four selected performance measures:4.5.1 Towing—the ability to tow the disabled ship under specified parameters,4.5.2 Stopping—the ability to stop the disabled ship within specified parameters,4.5.3 Turning—the ability to turn the disabled ship within specified parameters, and4.5.4 Holding steady—the ability to hold the disabled ship on a steady course under specified parameters.4.6 The “specified parameters” are additional details that must be factored into the performance analysis. These parameters might be specified by a regulatory agency imposing the escort requirement, by a study group evaluating the feasibility of escorting in a particular waterway, or by the ship or escort vessel operators themselves to define the performance envelope of their vessels. Some examples of these parameters are:4.6.1 A ship transit speed (at the moment of failure);4.6.2 The failure scenario (rudder failure alone, or simultaneous rudder/propulsion failure, degree of failure, and so forth);4.6.3 Navigational constraint within which the disabled ship must be brought under control (such as allowable advance and transfer, cross-track error, and so forth);4.6.4 Wind, current, and sea conditions; and4.6.5 Time delays, failure recognition, decision making, escort vessel notification, escort vessel positioning, achieving full power, and so forth.4.7 The anticipated users of this guide are:4.7.1 Ship owners/operators who are required to select escort vessel(s) that meet the performance measures addressed by this guide.4.7.2 Escort vessel designers/operators who need to evaluate the performance capabilities of their vessels with respect to the measures addressed by this guide.4.7.3 Regulatory agencies that have imposed the performance measures in this guide in a particular waterway to develop suitable escort vessel matrices for various sized ships in the waterway.4.7.4 Enforcement agencies can use this guide to confirm/verify compliance with the performance measures (that is, that suitable escort vessel(s) are being selected).4.7.5 Study groups can use this guide to explore the feasibility and effectiveness of escorting as a means of mitigating risk on a particular waterway.4.8 This guide does not address the use of escort vessels with barge fleets or barge tows. However, some sections of this guide would be useful if an evaluation of escort vessels with barge shipments were undertaken. Paragraphs 5.4 and 5.5, and all of Section 6 would apply in this type of analysis.4.9 The methodologies and processes presented in this guide will yield valid solutions to the performance measures. This means that the selected escort vessel(s) can reasonably be expected to control the disabled ship within the specified parameters. However, users are reminded that other circumstances surrounding the disabling incident may still preclude the escorts from safely responding (such as fire).4.10 The methodologies in this guide are not necessarily the only ones that can be used to find solutions for the performance measures. There may be other analytic approaches that also will yield valid results. It is hoped that as these alternative methods are developed, they will be incorporated into this guide.1.1 This guide covers the evaluation and selection of escort vessels that are to be used to escort ships transiting confined waters. The purpose of the escort vessel is to limit the uncontrolled movement of a ship disabled by loss of propulsion or steering to within the navigational constraints of the waterway. The various factors addressed in this guide also can be integrated into a plan for escorting a given ship in a given waterway. The selection of equipment also is addressed in this guide.1.2 This guide can be used in performance-based analyses to evaluate:1.2.1 The control requirement of a disabled ship,1.2.2 The performance capabilities of escort vessels,1.2.3 The navigational limits and fixed obstacles of a waterway,1.2.4 The ambient conditions (wind and sea) that will impact the escort response, and1.2.5 The maneuvering characteristics of combined disabled ship/escort vessel(s).1.3 This guide outlines how these various factors can be integrated to form an escort plan for a specific ship or a specific waterway. It also outlines training programs and the selection of equipment for escort-related activities.1.4 A flowchart of the overall process for developing and implementing an escort plan is shown in Fig. 1. The process begins with the collection of appropriate data, which are analyzed with respect to the performance criteria and in consultation with individuals having local specialized knowledge (such as pilots, waterway authorities, interest groups, or public/private organizations, and so forth). This yields escort vessel performance requirements for various transit speeds and conditions; these are embodied in the ship's escort plan. When the time comes to prepare for the actual transit, the plan is consulted in conjunction with forecast conditions and desired transit speed to select and dispatch the appropriate escort vessel (or combination of vessels). A pre-escort conference is conducted to ensure that all principal persons (ship master, pilot, and escort vessel masters) have a good understanding of how to make a safe transit and interact in the event of an emergency.FIG. 1 Flowchart of the Overall Process for Developing and Implementing an Escort Plan1.5 This guide addresses various aspects of escorting, including several performance criteria and methodologies for analyzing the criteria, as well as training, outfitting, and other escort-related considerations. This guide can be expanded as appropriate to add new criteria, incorporate “lessons learned” as more escorting experience is gained in the industry, or to include alternative methodologies for analyzing the criteria.1.6 This guide addresses physical control of the disabled ship with the assistance of the escort vessel(s). Other possible functions, such as firefighting, piloting, or navigational redundancy, are outside the scope of this guide. Also, this guide was developed for application to oceangoing ships in coastal waterways; it is not suitable for application to barge strings in riverine environments.1.7 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.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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