5.1 This guide provides a list of the standards within Committee D04 that address the use of materials, specifications, and construction practices that could have broader sustainability benefits. This list is current, relative to the approval date of the standard.5.2 The standards discussed are listed in the Referenced Documents section.5.3 This guide is intended to be used as a reference for an owner, engineer, contractor, or combinations thereof, to identify potential sustainability strategies and the respective material and construction standards and specifications. It is important to note that these standards do not ensure sustainability goals are achieved; rather, they may be useful in determining inputs for sustainability metrics.1.1 This guide is intended to be a reference for locating specific test methods relating to materials and construction standards within the jurisdiction of Committee D04 on Road and Paving Materials that could be a strategy used to meet project sustainability goals.1.2 The guide needs to be reviewed and updated by Subcommittee D04.99 on Sustainable Asphalt Pavement Materials and Construction, on an as-needed basis, to remain viable.1.2.1 Additions or deletions to the reference list in Section 2 shall be submitted to Subcommittee D04.99 and balloted.1.3 Units—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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Health information networks (HINs) have arisen in recent years as a way to share common information within organizational arrangements among those healthcare facilities that have been formed into large, more comprehensive integrated delivery systems (IDS) and managed care organizations (MCO) offering a full range of healthcare services, both inpatient and ambulatory.The specific organizational structures to which the MCO term was originally applied most probably have evolved into something quite different. Furthermore, IDS organizations are contracting with other organizations that have a market larger than a single IDS itself and are buying such services for themselves rather than offering them internally.These organizations will need a frame of reference for the global information needed to provide all of the services required during patient care. For a global Concept Model consult ADA Specification 1000.0–1000.18 and TR 1039.Pharmacotherapy will require a number of these services, including those of the clinical laboratory for therapeutic drug monitoring as well as pharmacy services of both resident and nonresident care organizations and stand-alone pharmacies to ensure freedom from medication errors and conduct ongoing investigations of both the outcomes of care and the management of resources related to pharmacotherapy.Pharmacotherapy functions include prescribing (clinical orders), dispensing, administering, and monitoring, which support “pharmaceutical care” defined as “provision of drug therapy to achieve desired therapeutic outcomes that improve a patient’s quality of life.” These functions address patients’ needs that require information support as noted in Table 1.Another aspect of the monitoring function is the development of instrumentation for testing at point of care (POCT) for high-value immediate-benefit services that support pharmacotherapy. POCT, however, needs supervision and training from skilled laboratorians for the actual performers, whether that supervision comes from within the IDS or outside of it. This range of operation is only achievable by distributed HIN structures that shall have the same quality of clinical and data services as offered by laboratories close at hand. Data management of POCT is documented separately (see CLSI POCT1, ASTP2), but such data management for support of pharmacotherapy shall be placed into the broader context of this practice and linked to CLSI LIS-9A. Thus, this practice should be used to first organize the global domain and then the interconnected subdomains.1.1 This practice applies to the process of defining and documenting the capabilities, logical data sources, and pathways of data exchange regarding pharmacotherapy information services within a given network architecture serving a set of healthcare constituents.1.2 This practice is not a technical implementation standard but, rather, describes how the implementation methods and techniques can be used to coordinate pharmacotherapy services logically within an electronic health record (EHR) systems environment involving participating organizations and sites connected by a networked communication system.1.3 This practice covers the content of the nodes and arcs of the resulting logical network involving EHR, pharmacy, and clinical laboratory-capable sites. This practice also considers the various purposes and organizational arrangements for coordinating pharmacotherapy services within the network boundaries and the considerations for connections among external networks.1.4 This practice refers to other standards for conventions within various data domains, such as pharmacy systems, clinical laboratory information management systems (CLIMS), and EHR systems, and for messaging conventions.1.5 This practice is intended to outline how integration of pharmacy, CLIMS, and EHR information systems can be undertaken to result in a transparent pharmacotherapy clinical decision support environment, regardless of the underlying implementation architecture, by describing the logical interoperability of information domains as facilitated by information and communications technology (ICT).1.6 This practice is directed at pharmacists, clinical pharmacologists, clinical laboratorians, information system managers, and information systems vendors for use in planning and implementing coordinated pharmacotherapy services through effective dialog.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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4.1 This guide is intended for use by those undertaking the development of fire hazard assessments for upholstered seating furniture in health care occupancies.4.2 As a guide this document provides information on an approach to development of a fire hazard assessment, but fixed procedures are not established. Section 1.7 describes some cautions to be taken into account.4.3 A fire hazard assessment developed following this guide should specify all steps required to determine fire hazard measures for which safety thresholds or pass/fail criteria can be meaningfully set by responsible officials using the standard.4.4 A fire hazard assessment developed as a result of using this guide should be able to assess a new item of upholstered seating furniture being considered for use in a certain health care facility, and reach one of the conclusions in 4.4.1 – 4.4.4.4.4.1 The new upholstered seating furniture item is safer, in terms of predicted fire performance, than the one in established use. Then, the new product would be desirable, from the point of view of fire safety.4.4.2 There is no difference between the predicted fire safety of the new item and the one in established use. Then, there would be neither advantage nor disadvantage in using the new product, from the point of view of fire safety.4.4.3 The new upholstered seating furniture item is predicted to be less safe, in terms of fire performance, than the one in established use. Then, the new item would be less desirable, from the point of view of fire safety than the one in established use.4.4.3.1 If the new upholstered furniture item is predicted to be less safe, in terms of fire performance, than the one in established use, a direct substitution of the products would provide a lower level of safety and the new product should not be used, without other compensatory changes being made. A new upholstered furniture product can, however, be made acceptable if, and only if, it is part of a complete, comprehensive, fire safety design for the patient room. Such a patient room redesign should include one or more of the following features: use of an alternative layout (albeit one that cannot be altered by the patient room users) or increased use of automatic fire protection systems or changes in other furnishings or contents. In such cases, a more in-depth fire hazard assessment should be conducted to ensure that all of the changes together have demonstrated a predicted level of fire safety for the new design which is at least equal to that for the design in established use, in order to permit the use of the new upholstered seating furniture item.4.4.3.2 Alternatively, the new design may still be acceptable if the predicted level of fire safety is commensurate with new stated fire safety objectives developed in advance.4.4.4 The new upholstered seating furniture item offers some safety advantages and some safety disadvantages over the item in established use. An example of this outcome could be increased smoke obscuration with decreased heat release. Then, a more in depth fire hazard assessment would have to be conducted to balance the advantages and disadvantages.4.5 If the patient room does not contain an upholstered seating furniture item, then the fire hazard assessment implications of the introduction of an upholstered seating furniture item should be analyzed in the same way as in 4.4. The fire safety should then be compared with that achieved in the room in established use (which has no upholstered seating furniture). The same analysis would also apply if an additional upholstered furniture item is being considered for introduction in a patient room: the fire hazard assessment should compare the fire safety implications of the addition.4.5.1 An additional upholstered furniture item adds to the fuel load of a room. Thus, an analysis such as that in 4.4 would offer options 4.4.2 through 4.4.4 only.4.6 Following the analysis described in 4.4, a fire hazard assessment developed following the procedures in this guide would reach a conclusion regarding the desirability of the furniture product studied.4.7 An alternative to the analysis based on the anticipated fire performance of the materials or products contained in the patient room is the use of active fire protection measures, such as fire suppression sprinklers. Active fire protection involves measures such as automatic sprinklers and alarm systems, while passive fire protection involves using materials that are difficult to burn and give off low heat and smoke if they do burn. Traditional prescriptive requirements are based exclusively on passive fire protection, with the common approach being to describe the fire tests to be met for every property. The opposite extreme is based entirely on active fire protection, which assumes that active fire protection measures (mostly sprinklers) ensure fire safety. The fire safety record of sprinklers is excellent, but not flawless. Moreover, neither approach gives the type of flexibility that is the inherent advantage of fire hazard and fire risk assessments.4.7.1 Note that the activation of automatic fire suppression sprinklers does not ensure a safe level of smoke obscuration.4.8 This guide provides information on a different type of fire hazard assessment than Guide E2061. While Guide E2061 considers an entire occupancy, namely a rail transportation vehicle, this guide addresses a specific product, namely upholstered furniture.1.1 This is a guide to developing fire hazard assessments for upholstered seating furniture, within patient rooms of health care occupancies. As such, it provides methods and contemporary fire safety engineering techniques to develop a fire hazard assessment for use in specifications for upholstered seating furniture in such occupancies.1.2 Hazard assessment is an estimation of the potential severity of the fires that can develop with certain products in defined scenarios, once the incidents have occurred. Hazard assessment does not address the likelihood of a fire occurring, but is based on the premise that an ignition has occurred.1.3 Because it is a guide, this document cannot be used for regulation, nor does it give definitive instructions on how to conduct a fire hazard assessment.1.4 This guide is intended to provide assistance to those interested in mitigating the potential damage from fires associated with upholstered furniture in patient rooms in health care occupancies.1.5 Thus, this guide can be used to help assess the fire hazard of materials, assemblies, or systems intended for use in upholstered furniture, by providing a standard basis for studying the level of fire safety associated with certain design choices. It can also aid those interested in designing features appropriate to health care occupancies. Finally, it may be useful to safety personnel in health care occupancies.1.6 This guide is a focused application of Guide E1546, which offers help in reference to fire scenarios that are specific to upholstered furniture in health care occupancies, and includes an extensive bibliography. It differs from Guide E1546 in that it offers guidance that is specific to the issue of upholstered furniture in patient rooms of health care facilities, rather than general guidance. Appendix X11 includes some statistics on the magnitude of the potential problem in the U.S.1.7 A fire hazard assessment conducted in accordance with this guide is strongly dependent on the limitations in the factors described in 1.7.1 – 1.7.4.1.7.1 Input data (including their precision or accuracy).1.7.2 Appropriate test procedures.1.7.3 Fire models or calculation procedures that are simultaneously relevant, accurate and appropriate.1.7.4 Advancement of scientific knowledge.1.8 This guide addresses specific fire scenarios which begin inside or outside of the patient room. However, the upholstered furniture under consideration is inside the patient room.1.9 The fire scenarios used for this hazard assessment guide are described in 9.2. They involve the upholstered furniture item within the patient room as the first or second item ignited, in terms of the room of fire origin. Additionally, consideration should be given to the effect of the patient room upholstered furniture item on the tenability of occupants of rooms other than the room of fire origin, and on that of potential rescuers.1.10 This guide does not claim to address all fires that can occur in patient rooms in health care occupancies. In particular, fires with more severe initiating conditions than those assumed in the analysis may pose more severe fire hazard than that calculated using this guide (see also 9.5).1.11 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.12 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.1.13 This fire standard cannot be used to provide quantitative measures.1.14 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 practice provides a procedure for determining the temperature history of plastic gas pressure pipe encased in metallic casings.The data obtained are indicative of the temperature attainable within a service riser of a specific design and size in a given geographical location under the climatogical conditions in existence during the test period.The data obtained can be used within the constraints of 4.2 to design the maximum allowable operating pressures permitted by existing codes.1.1 This practice describes a procedure for the determination of the temperature history of above-ground plastic gas pressure pipe encased in a metallic casing. Such temperature changes may be due to ambient air temperature, or solar exposure, or both.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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5.1 Stress is applied as pressure over the area of the flatjack. In the case of multi-wythe masonry, stress is estimated only in the wythe in which the flatjack is inserted. Stress in other wythes may be different.1.1 This test method covers the determination of the average compressive stress in existing unreinforced solid-unit masonry (see Note 1). This test method concerns the measurement of in-situ compressive stress in existing masonry by use of thin, bladder-like flatjack devices that are installed in cut mortar joints in the masonry wall. This test method provides a relatively non-destructive means of determining masonry properties in place.NOTE 1: Solid-unit masonry is that built with stone, concrete, or clay units whose net area is equal to or greater than 75 % of the gross area.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 A laboratory quality assurance program is an essential program for laboratories within the nuclear industry. Guide C1009 provides guidance for establishing a quality assurance program for an analytical laboratory within the nuclear industry. This guide deals with the control of measurements aspect of the laboratory quality assurance program. Fig. 1 shows the relationship of measurement control with other essential aspects of a laboratory quality assurance program.FIG. 1 Quality Assurance of Analytical Laboratory Data4.2 The fundamental purposes of a measurement control program are to provide the with-use assurance (real-time control) that a measurement system is performing satisfactorily and to provide the data necessary to quantify measurement system performance. The with-use assurance is usually provided through the satisfactory analysis of quality control samples (reference value either known or unknown to the analyst). The data necessary to quantify measurement system performance is usually provided through the analysis of quality control samples or the duplicate analysis of process samples, or both. In addition to the analyses of quality control samples, the laboratory quality control program should address (1) the preparation and verification of standards and reagents, (2) data analysis procedures and documentation, (3) calibration and calibration procedures, (4) measurement method qualification, (5) analyst qualification, and (6) other general program considerations. Other elements of laboratory quality assurance also impact the laboratory quality control program. These elements or requirements include (1) chemical analysis procedures and procedure control, (2) records storage and retrieval requirements, (3) internal audit requirements, (4) organizational considerations, and (5) training/qualification requirements. To the extent possible, this standard will deal primarily with quality control requirements rather than overall quality assurance requirements, which are addressed in Guide C1009.4.3 Although this guide uses suggestive rather than prescriptive language (for example, “should” as opposed to “shall”), the elements being addressed should not be interpreted as optional. An effective and comprehensive laboratory quality control program should, at minimum, completely and adequately consider and include all elements listed in Section 1 and in the corresponding referenced sections of this guide.1.1 This guide provides guidance for establishing and maintaining a measurement system quality control program. Guidance is provided for general program considerations, preparation of quality control samples, analysis of quality control samples, quality control data analysis, analyst qualification, measurement system calibration, measurement method qualification, and measurement system maintenance.1.2 This guidance is provided in the following sections:  SectionGeneral Quality Control Program Considerations 5Quality Control Samples 6Analysis of Quality Control Samples 7Quality Control Data Analysis 8Analyst Qualification 9Measurement System Calibration 10Qualification of Measurement Methods and Systems 11Measurement System Maintenance 121.3 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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This guide provides a recommended systematic sequence for using the referenced test methods for evaluating the durability of EC insulating glass units (IGUs) as described in section 1.2. , (See Appendix X1, Section X1.4.)This guide provides a summary of the durability issues addressed by each of the series of standards that are necessary for assesing the durability of electrochromic coatings (ECCs) in insulating glass units (IGUs). When fully implemented in buildings in the U.S., ECCs in IGUs have the potential of significantly reducing our current energy consumption for all uses-not just buildings. IGUs with ECCs will, of necessity, have to be able to pass the applicable standards listed in Appendix X1, Section X1.4, as well as an ASTM standard on wind loading for IGUs. Passing these will not be sufficient because the operating temperatures of ECCs in IGUs can potentially be as high as 90°C at the center-of glass, whereas the highest temperature used in Test Method E2188 is 60°C . Listings of existing and proposed standards are given in Table 1 and in Appendix X1, Section X1.4.1.1 This guide provides the recommended sequence for using the referenced ASTM test methods for assessing the durability of absorptive electrochromic coatings (ECCs) within sealed insulating glass units. Cross sections of typical electrochromic glazings have three to five-layers of coatings that include one to three active layers sandwiched between two transparent conducting electrodes (TCOs, see Section 3). Examples of the cross-sectional arrangements can be found in “Evaluation Criteria and Test Methods for Electrochromic Windows.” (For a list of acronyms used in this standard, see Appendix X1, Section X1.1).1.2 This guide is applicable only for layered (one or more active coatings between the TCOs) absorptive ECCs on vision glass (superstrate and substrate) areas planned for use in IGUs for buildings, such as glass doors, windows, skylights, and exterior wall systems. The layers used for electrochromically changing the optical properties may be inorganic or organic materials between the superstrate and substrate.1.3 The ECCs used in this guide will ultimately be exposed (Test Method E2141) to solar radiation and deployed to control the amount of radiation by absorption and reflection and thus, limit the solar heat gain and amount of solar radiation that is transmitted into the building.1.4 This guide is not applicable to other types of coatings on vision glass with other chromogenic coatings, for example, photochromic and thermochromic coatings.1.5 This guide is not applicable to IGUs that will be constructed from superstrate or substrate materials other than glass.1.6 The test methods referenced in this guide are laboratory test methods conducted under specified conditions.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 There is no comparable International Standards Organization 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 and health practices and determine the applicability of regulatory requirements prior to use.

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4.1 Plasticizer migration is detrimental to many adhesives, including hot melts, which could be possibly used in conjunction with PVC backed flooring materials, whether resilient or textile, broadloom, tile or plank. This practice can be used as an indicator to determine if plasticizers in the flooring material are compatible with proposed installation adhesive(s).1.1 This standard will provide a qualitative means to determine the potential effects of plasticizers contained within polyvinyl chloride (PVC) floor covering materials on a specific adhesive.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 Under the severe conditions of this test method, the specimens undergo degradation at a rate that is dependent upon the thermal endurance of the polypropylene material under examination.5.2 The thermal level of this test method is considered sufficiently severe to cause failure of commercial grades of heat-stable polypropylene within a reasonable period of time. If desired, lower temperatures can be applied to estimate the performance of polypropylene materials with lower heat stability.5.3 The technique of specimen rotation described in this test method provides an estimate of the life-temperature relationship of polypropylene. If this test method is conducted at different temperatures on the same material, a more reliable estimate of the life-temperature relationship of polypropylene is determined. This test method can be conducted at several temperatures and the data interpreted through use of the Arrhenius relation, by plotting the logarithms of times to failure against the reciprocals of the temperatures in kelvins (K). Temperatures in the range from 100 to 150°C, with intervals of 10°C, are suggested for this purpose.5.4 The stability as determined under the prescribed test method is not directly related to the suitability of the compound for a use where different conditions prevail.5.5 The specimen rotation technique of thermal aging increases the probability that all specimens will be exposed similarly and that the effect of temperature gradients in an oven will be minimized.1.1 This test method provides a means for estimating the resistance of polypropylene, in molded form, to accelerated aging by heat in the presence of air using a forced draft oven.1.2 The stability determined by this test method is not directly related to the suitability of the material for use when different environmental conditions prevail and shall not be used to predict performance.NOTE 1: The specified thermal levels in this test method are considered sufficiently severe to cause failure of commercial grades of heat-stable polypropylene within a reasonable period of time. If desired, lower temperatures can be applied to estimate the performance of polypropylene with lower heat stabilities.1.3 The values stated in SI units are to be regarded as the standard. The values 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.NOTE 2: This test method and ISO 4577–1983 are technically similar but different in preparation of test specimens, thickness of test specimen, measurement of the number of air flow changes in the ovens, and the number of air changes per hour required.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 This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity. This test method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. This test method should be combined with other methods of evaluating overall package integrity, uniformity of the package seal, or opening functionality, if so required.5.2 This test frequently is used to quickly evaluate package seal strength during the manufacturing process and at various stages of the package's life cycle.5.3 If correlations between pieces of test equipment are to be made it is important that all parameters of the test be equivalent. Typical parameters can include, but are not limited to the package size, material, type and configuration of seal, rate of air flow into the package, pressure detection sensing mechanism and sensitivity (machine response to pressure drop), position of test article, rigidity of restraining plates, and distance between restraining plates. See Appendix X2 for further information.5.4 This test may not necessarily provide correlation with package seal strength as typically measured using Test Methods F1140 or F88 (or equivalents).1.1 This test method covers the procedure for determining the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates.1.2 The test methods described herein are functionally similar to Test Methods F1140 with the exception of the use of restraining plates. Test Methods F1140 describes methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability to withstand pressurization stresses. Under Test Methods F1140 the stresses are not distributed uniformly to all areas of the package seal. Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods F1140 may not reliably detect the weakest area of the seal.1.3 The burst test internally and increasingly pressurizes a package until an area of the package seal around the perimeter “bursts” open in response to pressurization. By placing the package within restraining plates during pressurization, the dimensional stability of the package is maintained in a manner that results in stresses applied more uniformly along the perimeter of the package, where seals are normally placed. This allows the test to have a higher probability of detecting the weakest area of the seal and provide a measurement of the pressure required to “burst” open the package.1.4 This test only applies to flexible packages with seals placed around the perimeter of a flexible package (often referred to as a pouch). In particular it is intended as applicable to packages with seals that have a peelable seal feature (peeled open by end user to remove contents of package).1.4.1 Porous barrier materials' failure to reach adequate pressure to burst the package seals may be due to insufficient volume flow. See Appendix X4 for information.1.5 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, 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.1.6 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. Particular caution is advised where users of this procedure may be required to design and fabricate restraining plate fixtures. Reference Appendix X3 for further information regarding calculation of stress factors and structural design considerations.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The number and distribution of viable and non-viable cells within, or on the surface of, a biomaterial scaffold is one of several important characteristics that may determine in vivo product performance of cell/biomaterial constructs (see 5.7); therefore, there is a need for standardized test methods to quantify cell viability.5.2 There are a variety of static and dynamic methods to seed cells on scaffolds, each with different cell seeding efficiencies. In general, static methods such as direct pipetting of cells onto scaffold surfaces have been shown to have lower cell seeding efficiencies than dynamic methods that push cells into the scaffold interior. Dynamic methods include: injection of cells into the scaffold, cell seeding on biomaterials contained in spinner flasks or perfusion chambers, or seeding that is enhanced by the application of centrifugal forces. The methods described in this guide can assist in establishing cell seeding efficiencies as a function of seeding method and for standardizing viable cell numbers within a given methodology.5.3 As described in Guide F2315, thick scaffolds or scaffolds highly loaded with cells lead to diffusion limitations during culture or implantation that can result in cell death in the center of the construct, leaving only an outer rim of viable cells. Spatial variations of viable cells such as this may be quantified using the tests within this guide. The effectiveness of the culturing method or bioreactor conditions on the viability of the cells throughout the scaffold can also be evaluated with the methods described in this guide.5.4 These test methods can be used to quantify cells on non-porous or within porous hard or soft 3-D synthetic or natural-based biomaterials, such as ceramics, polymers, hydrogels, and decellularized extracellular matrices. The test methods also apply to cells seeded on porous coatings.5.5 Test methods described in this guide may also be used to distinguish between proliferating and non-proliferating viable cells. Proliferating cells proceed through the DNA synthesis (S) phase and the mitosis (M) phase to produce two daughter cells. Non-proliferating viable cells are in some phase of the cell cycle, but are not necessarily proceeding through the cell cycle culminating in proliferation.5.6 Viable cells may be under stress or undergoing apoptosis. Assays for evaluating cell stress or apoptosis are not addressed in this guide.5.7 While cell viability is an important characteristic of a TEMP, the biological performance of a TEMP is dependent on additional parameters. Additional tests to evaluate and confirm the cell identity, protein expression, genetic profile, lineage progression, extent of differentiation, activation status, and morphology are recommended.5.8 The main focus of this document is not scaffold toxicity or the toxicity of the scaffold raw materials. This document is meant to address the situation where a scaffold that is thought to be cytocompatible is cultured with cells and the user desires to assess the viability of cells within the construct. Prior to conducting the tests described herein, the raw materials used to make the scaffold should be assessed as described in Practice F748. This testing may include assessment of the release of toxic leachables from the raw materials.5.9 Methods that remove the cells from a 3-D scaffold may reduce the cell number and viability due to the manipulation required.5.10 Some scaffold constructs may prevent reliable measurements of cell viability within the scaffolds using the methods described herein. Scaffolds may limit diffusion of assay components into and out of the scaffolds. This is especially problematic for methods that require dyes to penetrate into the scaffold, that require detergents or other cell-lysing agents to diffuse into the construct, that require lysed-cell components to diffuse out of the constructs, or that require assay reactants to diffuse into or out of the scaffold. Diffusion in scaffolds and assay results may also be affected by dense cell populations in scaffolds, the generation of tissue-like structures by the cells within the scaffold, and the presence of cell-generated extracellular matrix (ECM) in the scaffold. The formation of tight junctions between cells and cell-ECM interactions may also limit diffusion, especially in the case of hard tissues such as bone.5.11 Assay results may be affected by interactions between assay components and the scaffold. Assay components may adsorb to the surface of the scaffold which would affect their participation in the assay and the resulting assay signal. Biochemical interactions between the scaffold and assay components may cause activation or inhibition of the assay chemistries.5.12 Different cell viability tests may measure different things and may not agree with one another. A large variety of cell viability assays have been developed to measure different aspects of the cell death process. Some of the common measurements include penetration of dyes into the cell, cell metabolic activity, cellular ATP, and leakage of intracellular components out of the cell. Each of these phenomena are related to the state of cell viability in different ways, and may represent different attributes of the cell death process. The mechanism of cell death will also affect the results for these different types of viability measurements. Necrosis, oxygen depravation, starvation, chemical toxicity, apoptosis, anoikis, and mechanical damage represent some of the causes of cell death. Each of these mechanisms may have different effects on the different aspects of cell death that are measured by cell viability assays.1.1 This guide is a resource of cell viability test methods that can be used to assess the number and distribution of viable and non-viable cells within porous and non-porous, hard or soft biomaterial scaffolds, such as those used in tissue-engineered medical products (TEMPs).1.2 In addition to providing a compendium of available techniques, this guide describes materials-specific interactions with the cell assays that can interfere with accurate cell viability analysis, and includes guidance on how to avoid or account for, or both, scaffold material/cell viability assay interactions.1.3 These methods can be used for 3-D scaffolds containing cells that have been cultured in vitro or for scaffold/cell constructs that are retrieved after implantation in living organisms.1.4 This guide does not propose acceptance criteria based on the application of cell viability test methods.1.5 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.

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4.1 The mission of an analytical laboratory is to provide quality analyses on nuclear fuel cycle materials. An analytical laboratory QA program is comprised of planned and systematic actions needed to provide confidence that this mission is conducted in an acceptable and consistent manner.4.2 The analytical laboratories involved in the analysis of nuclear fuel cycle materials are required to implement a documented QA program. Regulatory agencies may mandate some form of control requirements for all or a part of a laboratory's operation. A documented QA program is also necessary for those laboratory operations required to comply with ASME NQA-1 or ISO/IEC 17025, or the requirements of many accreditation bodies. Even when not mandated, laboratory QA programs should be established as a sound and scientific technical practice. This guide provides guidance for establishing and maintaining a QA program to control those analytical operations vital to ensuring the quality of chemical analyses.4.3 Quality assurance programs are designed and implemented by organizations to assure that the quality requirements for a process, product or service will be fulfilled. The quality system is complementary to technical requirements that may be specific to a process or analytical method. Each laboratory should identify applicable program requirements and use standards to implement a quality program that meets the appropriate requirement. This guide may be used to develop and implement an analytical laboratory QA program. Other useful implementation standards and documents are listed in Section 2 and Appendix X1.4.4 The guides for QA in the analytical laboratory within the nuclear fuel cycle have been written to provide guidance for each of the major activities in the laboratory and are displayed in Fig. 1. The applicable standard for each subject is noted in the following sections.FIG. 1 Essential Elements of Analytical Laboratory Quality Assurance System4.5 Although this guide describes “Recommended Practices” and “Recommendations” and uses suggestive rather than prescriptive language (for example, “should” as opposed to “shall”), the elements being addressed should not be interpreted as optional. An effective and comprehensive laboratory quality assurance/quality control program completely and adequately considers and includes all elements listed in Sections 5 – 17 of this guide.1.1 This guide covers the establishment and maintenance of a quality assurance (QA) program for analytical laboratories within the nuclear industry. References to key elements of ASME NQA-1 and ISO/IEC 17025 provide guidance to the functional aspects of analytical laboratory operations. When implemented as recommended, the practices presented in this guide will provide a comprehensive QA program for the laboratory. The practices are grouped by functions, which constitute the basic elements of a laboratory QA program.1.2 The essential, basic elements of a laboratory QA program appear in the following order:  SectionOrganization 5Quality Assurance Program 6Training and Qualification 7Procedures 8Laboratory Records 9Control of Records 10Management of Customer Requests and Commitments to Customers 11Control of Procurement 12Control of Measuring Equipment and Materials 13Control of Measurements 14Control of Nonconforming Work 15Candidate Actions 16Preventative Actions 171.3 Collection of samples and associated sampling procedures are outside the scope of this guide. The user may refer to sampling practices developed by Subcommittee C26.02.1.4 Nuclear laboratories are required to handle a variety of hazardous materials, including but not limited to radioactive samples and materials. The need for proper handling of these materials is discussed in 13.2.4. While this guide focuses on the nuclear laboratory QA program, proper handling of nuclear materials is essential for proper function of the QA program.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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6.1 The purpose of this test method is to establish impact attenuation for the installed playground surface at the time of testing.6.2 This test method provides a uniform means of quantifying the impact attenuation performance of installed playground surfaces.6.3 This test method is to be used as a reference for specifying the impact attenuation performance of an installed playground surface.6.4 This test method provides a uniform means of comparing the impact attenuation performance of installed playground surfaces with the performance requirements of this test method and with other performance requirements expressed in terms of drop height. Consequently, the test method is appropriately used to determine the actual impact attenuation performance of installed playground surfaces under ambient conditions of use.6.5 In combination with data relating impact test scores to head injury, the information generated by application of this test method is suitable to estimate the relative risk of a severe head injury due to a fall.6.6 Performance of this test does not satisfy the requirements to certify surfaces to the specification Specification F1292.1.1 This test method provides a means of determining impact attenuation performance of a playground using a test method that simulates the impact of a child's head with the playground surfaces.1.2 This test method is specific to surfacing materials used in conjunction with playground equipment, such as that described in Specifications F1148, F1487, F1918, CSA Z614 (Canada), and SS457 (Singapore).1.3 This test method establishes procedures for determining the impact attenuation value of playground surfaces as tested in the field and for comparison with the test performed under laboratory conditions in Specification F1292 and contract and warranty requirements. This test method does not establish the critical fall height for an installed playground surface.1.4 The field test required by this test method addresses the performance of playground surfaces as they are found in the field during a time when play by children 2-12 is anticipated.1.5 The impact attenuation test method and test methods established in this test method are specific to the risk of head injury. There is evidence that lowering impact attenuation values can reduce the risk of other kinds of serious injury (for example, long bone fractures).1.6 This test method relates only to the impact attenuation properties of playground surfacing materials and does not address other factors that contribute to fall-related injuries. While it is believed that conformance with the requirements of this test method will reduce the risk of severe injury and death from falls, adherence to this test method will not prevent all injuries and deaths.1.7 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.1.8 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 Hydration is a critical aspect of GCCM installation. GCCM installations are often hydrated with excess water to ensure that a saturated condition exists. Therefore, it is not generally possible to monitor and control exactly the water addition that absorbs and hydrates the cementitious materials due the practical methods of hydration in use.5.2 It is important to be able to distinguish the quality of cementitious material used in applications for GCCMs. A measurement of compressive strength properties of the cementitious material is often an accepted method to provide a measure of the cement strength and quality. The compressive strength properties will vary with the water/cementitious material ratio and, therefore, it is necessary to determine a practical value that approximates in-use hydration and not a water/cementitious material ratio that simply provides the maximum properties but cannot be expected as representative of actual use conditions.5.3 The compressive strength of the cementitious material can be affected by both over and under hydration.5.4 This method identifies a means to obtain a water/cementitious material ratio representative of that obtained by proper hydration of GCCMs to allow replication for laboratory compressive strength testing for use by GCCM designers, inspectors, and installers.1.1 The purpose of the proposed test method is to obtain a water/cementitious material ratio that allows for a practical measurement of the compressive strength of the cementitious material contained within a geosynthetic cementitious composite mat (GCCM). This water/cementitious material ratio should be generally representative of that achieved practically upon the hydration of a GCCM. Because GCCM materials do not involve mixing or the use of exact water hydration methods when employed in the field, this method is necessary to provide a quantitative estimate of the water/cementitious material ratio.1.2 This procedure determines the water/cementitious material ratio for a properly hydrated GCCM, which is then used to create cube or cylinder specimens for compressive strength testing as per the appropriate referenced ASTM test methods. Compressive strength results will then be representative of the strength of the inherent cementitious material found in the GCCM after normal GCCM hydration.1.3 The values in SI units are to be regarded as standard. Values in inch-pound units are in parentheses for information.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 This practice can be used in a single laboratory for trace analysis (that is, where: 1) there are concentrations near the lower limit of the method and 2) the measurements system’s capability to discriminate analyte presence from analyte absence is of interest). In these testing situations, a reliable estimate of the minimum level at which there is confidence that detection of the analyte by the method represents true presence of the analyte in the sample is key. Where within-laboratory detection is important to data use, the WDE procedure should be used to establish the within-laboratory detection capability for each unique application of a method.5.2 When properly applied, the WDE procedure ensures that the 99 %/95 % WDE has the following properties:5.2.1 Routinely Achievable Detection—The laboratory is able to attain detection performance routinely, using studied measurement systems, without extraordinary effort, and therefore at reasonable cost. This property is needed for a detection limit to be practically useful while scientifically sound. Representative equipment and analysts must be included in the study that generates the data to calculate the WDE.5.2.2 Inclusion of Routine Sources of Error—If appropriate data are used in calculation, the WDE practice will realistically account for sources of variation and bias common to the measurement process and routine for sample analysis. These sources include, but are not limited to: 1) intrinsic instrument noise, 2) some typical amount of carryover error, and 3) differences in analysts, sample preparation, and instruments (including signal-processing methods and software versions).5.2.3 Exclusion of Avoidable Sources of Error—The WDE practice excludes avoidable sources of bias and variation, (that is, those which can reasonably be avoided in routine field measurements). Avoidable sources would include, but are not limited to: 1) inappropriate modifications to the method, the sample, measurement procedure, or measurement equipment, and 2) gross and easily discernible transcription errors (provided there was a way to detect and either correct or eliminate such errors in routine sample testing).5.2.4 Low Probability of False Detection—Consistent with a measured concentration threshold (YC), the WCL is a true concentration that will provide a high probability (estimated at 99 %) of true non-detection (and thus a low estimated probability of false detection (α) equal to 1 %). Thus, when a sample with a real concentration of zero is measured, the probability of not detecting the analyte (that is, the probability that the measured value of the blank will be less than the WCL) would be greater than 99 %. To be most useful, this property must be demonstrated for the particular matrix being used, and not just for reagent-grade water.5.2.5 Low Probability of False Non-detection—Where appropriate data have been used for calculations, the WDE provides a true concentration at which there is a high estimated probability (at least 95 %) of true detection (and thus a low estimated probability of false non-detection (β) equal to 5 % at the WDE), with a simultaneously low estimated probability of false detection. Thus, when a sample with a true concentration at the WDE is measured, the probability of detection would be estimated to be at least 95 %. To be useful, this property must be demonstrated for the particular matrix being used, and not just for reagent-grade water.Note 1—The referenced probabilities, α and β, are key parameters for risk-based assessment of a detection limit.5.3 When this practice is utilized by a laboratory to develop these false-positive- and false-negative-control point estimates, from data representative of routine operations, the laboratory may confidently claim these levels of false-positive and false-negative control in the future, so long as the data used remain representative of that future operation. The laboratory may also qualify reported data using the appropriate point estimates (for example YC, YD, WCL, WDE) or censor data below the WCL as a valid basis for these data-reporting practices.5.3.1 The WDE Standard does not provide the basis for any prospective use of the test method by other laboratories for reliable detection of low-level concentrations, even for the same analyte and same media (matrix).5.3.2 The WDE values from a given laboratory may be used to compare the detection power of different methods for analysis of the same analyte in the same matrix by that laboratory.5.4 The WDE practice applies to measurement methods for which calibration error (that is, the error in the calibration of the measurement system) is minor relative to the combined other sources of variability. Some examples of other sources and when they may be dominant are:5.4.1 Sample preparation (dominant especially when calibration standards do not go through sample-preparation steps).5.4.2 Differences in analysts where a laboratory has more than one person who may perform each method step.5.4.3 Instrument differences (measurement equipment), which could take the form of differences in manufacturer, model, hardware, electronics, separation columns, sampling rate, chemical-processing rate, integration time, software algorithms, internal-signal processing and thresholds, effective sample volume, and contamination level.5.5 Reducing calibration error by use of allowable, though more stringent, calibration procedures (for example, multiple concentrations, replication, tight calibration-acceptance criteria, etc.) and through calibration verification (for example, analysis of a traceable standard from a second, independent source, calibration diagnostics) can reduce the magnitude of the calibration error.5.6 Alternative Data-Quality Objectives—Other values for α, β, confidence, etc. may be chosen as parameters; however, this procedure addresses only those stated here in.5.7 Collectively, the many sources of variation combine to cause within-laboratory measurements at any true concentration to be normally distributed. The assumption of normality is important for some of the statistics used; data normality should be assessed if there is reason to believe this assumption is not valid.5.8 If control of false negatives is not a data-quality objective, the WCL determined through this procedure provides a sound criterion for future determination of false-positive control; in such cases, the laboratory may confidently claim that true values above the WCL have a statistically significant difference from like-matrix zero-concentration samples (for example, from the method blank), but nothing more.5.9 Where as-measured values (for example, not corrected for bias), not true values are of interest, YC and YD may be used as these as-measured levels of the WCL and WDE.1.1 This practice provides a procedure for computing a 99 %/95 % Within-laboratory Detection Estimate (WDE) and the associated critical level/value (WCL). The WDE is the minimum concentration, with false positives and false negative appropriately controlled, such that values above these minimums are reliable detections. The WCL is the point at which only false positives are controlled appropriately. A false positive is the reporting of an analyte as present when the analyte is not actually present; false negatives are reports of analyte absence when the analyte is actually present. This practice is distinguished from the Interlaboratory Detection Estimate (IDE) practice in that the IDE Standard utilizes data from multiple, independent laboratories, while this practice is for use by a single laboratory. The IDE would be utilized where interlaboratory issues are of concern (for example, limits for published methods); this practice (and values derived from it) are applicable where the results from a single laboratory, single operator, single instrument, etc. are involved (for example, in understanding, censoring and reporting data).1.2 The establishment of a WDE involves determining the concentration below which the precision and bias of an analytical procedure indicates insufficient confidence in false-positive and false-negative control to assert detection of the analyte in the future analysis of an unknown number of samples. Most traditional approaches attempt to determine this detection “limit” by estimating precision at only a single, arbitrary point. The WDE approach is intended to be a more technically rigorous replacement for other approaches for estimating detection limits. The WDE practice addresses a number of critical issues that are ignored in other approaches.1.2.1 First, rather than making a single-point estimate of precision, the WDE protocol requires an estimate of precision at multiple points in the analytical range, especially in the range of the expected detection limit. These estimates are then used to create an appropriate model of the method’s precision. This approach is a more credible way to determine the point where relative precision has become too large for reliable detection. This process requires more data than has been historically required by single-point approaches or by processes for modeling the relationship between standard deviation and concentration.1.2.2 Second, unlike most other approaches, the WDE process accounts for analytical bias at the concentrations of interest. The relationship of true concentration to measured concentration (that is, the recovery curve) is established and utilized in converting from as-measured to true concentration.1.2.3 Third, most traditional approaches to detection limits only address the issue of false positives. Although false negatives may not be of concern in some data uses, there are many uses where understanding and/or control of false negatives is important. Without the false-negative-control information, data reported with just a critical-level value are incompletely described and the qualities of data at these levels incompletely disclosed.1.2.4 Fourth and last, the WDE standard utilizes a statistical-tolerance interval in calculations, such that future measurements may reasonably be expected to be encompassed by the WDE 90 % of the time. Many older approaches have used the statistical confidence interval, which is not intended to encompass individual future measurements, and has been misunderstood and misapplied. Procedures using the confidence interval cannot provide the stated control when the detection-limit value is applied to future sample results; such application is the primary use of these values.1.3 To summarize, the WDE is computed to be the lowest true concentration at which there is 90 % confidence that a single (future) measurement (from the studied laboratory) will have a true detection probability of at least 95 % and a true non-detection probability of at least 99 % (when measuring a blank sample). For the laboratory in the study, the critical value is the true concentration at which, on average, (with approximately 90 % confidence) will not be exceeded by 99 % of all measurements of samples with true concentration of zero (that is, blanks). These values are established by modeling the precision and establishing the recovery/bias over a range of concentrations, as well as by using a tolerance interval. The complexities of the WDE procedure may appear daunting, but the additional considerations are necessary if meaningfully estimates of the actual detection capabilities of analytical methods are to be made. The concepts are tractable by degreed chemists, and the use of the available ASTM DQCALC Excel-based software makes the data analysis and limit determinations easy.1.4 A within-laboratory detection estimate is useful in characterizing the concentration below which a method, for an analyte, as implemented in a specific laboratory, does not (with high confidence) discriminate the presence of the analyte from that of the absence of an analyte. As such an estimator, the WDE Standard (and the WDE and WCL values produced through its application) are useful where a trace-analysis testing method needs to be used.

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