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5.1 Interlaminar delamination growth can be a critical failure mode in laminated CMC structures. Knowledge of the resistance to interlaminar delamination growth of a laminated CMC is essential for material development and selection, and for CMC component design. (See (1-8)3 which give GIc values of 20 J/m2 to 800 J/m2 for different CMC and carbon-carbon composite systems at ambient temperatures.)5.2 Conducting this test produces multiple values of GIc which are traditionally plotted against the delamination length at which that value was measured (see Fig. 2). The specific data of value to the test requestor will depend on the end use that motivated testing.5.2.1 The first increment of growth, initiated from a pre-implanted insert or machined notch, is sometimes described as the non-precracked (NPC) toughness. NPC toughness may be of interest, as it can represent manufacturing or processing defects, such as foreign object debris in a laminate or an error during machining.5.2.2 The next increment of growth, initiated from the sharp crack tip assumed to be present after the first increment, is sometimes defined as the precracked (PC) toughness. PC toughness may be of interest, as it is more representative of the resistance to delamination growth from a naturally occurring or damage-induced delamination.5.2.3 The remaining increments of growth, collectively forming an R-curve, provide information on how GIc evolves as the delamination advances. In unidirectional tape laminates, the R-curve is often increasing due to bridging of nested fibers across the delamination plane, artificially increasing GIc. For 2-D woven laminates for which there is little interply nesting, the R-curve may be flat.5.2.4 The increments of growth in which the R-curve is flat, and GIc has reached a steady state value defined as GIR, may be of interest and may also useful in design and analysis.5.3 This test method for measurement of GIc of CMC materials can serve the following purposes:5.3.1 To establish quantitatively the effect of CMC material variables (fiber interface coatings, matrix structure and porosity, fiber architecture, processing and environmental variables, conditioning/exposure treatments, etc.) on GIc and the interlaminar crack growth and damage mechanisms of a particular CMC material;5.3.2 To determine if a CMC material shows R-curve behavior where GIc changes with crack extension or reaches a stable value at a given amount of delamination growth. Fig. 2 shows R-curve behavior for a SiC-SiC composite (1);5.3.3 To develop delamination failure criteria and design allowables for CMC damage tolerance, durability or reliability analyses, and life prediction;NOTE 3: Test data can only reliably be used for this purpose if there is confidence that the test is yielding a material property and not a structural, geometry-dependent, property.5.3.4 To compare quantitatively the relative values of GIc for different CMC materials with different constituents and material properties, reinforcement architectures, processing parameters, or environmental exposure conditions; and5.3.5 To compare quantitatively the values of GIc obtained from different batches of a specific CMC material, to perform lot acceptance quality control, to use as a material screening criterion, or to assess batch variability.1.1 This test method describes the experimental methods and procedures for the determination of the critical mode I interlaminar strain energy release rate of continuous fiber- reinforced ceramic matrix composite (CMC) materials in terms of GIc. This property is also sometimes described as the mode I fracture toughness or the mode I fracture resistance.1.2 This test method applies primarily to ceramic matrix composite materials with a 2-D laminate structure, consisting of lay-ups of continuous ceramic fibers, in unidirectional tape or 2-D woven fabric architectures, within a brittle ceramic matrix.1.3 This test method determines the elastic strain energy released per unit of new surface area created as a delamination grows at the interlaminar interface between two lamina or plies. The term delamination is used in this test method to specifically refer to this type of growth, while the term crack is a more general term that can also refer to matrix cracking, intralaminar delamination growth, or fiber fracture.1.4 This test method uses a double cantilever beam (DCB) specimen to determine the critical mode I interlaminar strain energy release rate (GIc). A DCB test method has been standardized for polymer matrix composites (PMCs) under Test Method D5528. This test method addresses a similar procedure, but with modifications to account for the different physical properties, reinforcement architectures, stress-strain response, and failure mechanisms of CMCs compared to PMCs.1.5 This test is written for ambient temperature and atmospheric test conditions, but the test method can also be used for elevated temperature or environmental exposure testing with the use of an appropriate environmental test chamber, measurement equipment for controlling and measuring the chamber temperature, humidity, and atmosphere, high temperature gripping fixtures, and modified equipment for measuring delamination growth.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6.1 Values expressed in this test method are in accordance with the International System of Units (SI) and IEEE/ASTM SI 10.1.7 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. Specific hazard statements are given in Section 8.1.8 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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5.1 HACCP is a proactive management tool that serves to reduce hazards potentially expressed as adverse biological or environmental effects, for example, associated with chemical releases, changes in natural resource or engineering practices and their related impacts, and accidental or intentional releases of biological stressors such as invasive species.5.2 Sequential implementation of HACCP and feedback in the iterative HACCP process allows for technically-based judgments concerning, for example, natural resources or the use of natural resources. Implementing the HACCP process serves to reduce adverse effects potentially associated with a particular material or process, and provides guidance for testing and evaluation of products or processes, through a pre-emptive procedure focused on information most pertinent to a system’s characterization. For example, identification of CCPs assure that processes and practices can be managed to achieve hazard reduction. For different processes and situations, HA may be based on substantially different amounts and kinds of, for example, biological, chemical, physical, and toxicological data, but the identification of CCPs serving to reduce hazard is key to successful implementation of HACCP.5.3 HACCP should never be considered complete for all time, and continuing reassessment is a characteristic of HACCP evaluations, especially if there should be changes in, for example, production volumes of a material, or its use or disposal increases, new uses are discovered, or new information on biological, chemical, physical, or toxicological properties becomes available. Similarly, HACCP should be considered an ongoing process serving as a key component in engineering practices, for example, related to construction activities and land-use changes, and natural resource management practices, for example, related to habitat use, enhancement, and species introductions such as fish-stocking programs. Periodic review of a system’s performance will help assure that new circumstances and information receive prompt and appropriate attention.5.4 In many cases, consideration of adverse effects should not end with completion of the HA and identification of CCPs key to the development of control measures. Additional steps may subsequently include risk assessment, and decisions concerning acceptability of identified hazards and risks, and mitigation actions potentially applicable to the process or practice that initially motivated HACCP.1.1 This guide describes a stepwise procedure for using existing information, and if available, supporting field and laboratory data concerning a process, materials, or products potentially linked to adverse effects likely to occur in the environment as a result of an event associated with a process such as the dispersal of a potentially invasive species or the release of material (for example, a chemical or a physical substance) or its derivative products to the environment. Hazard Analysis-Critical Control Point (HACCP) evaluations were historically linked to food safety (Hulebak and Schlosser W. 2002 (1);2 Mortimer and Wallace 2013 (2)), but the process has increasingly found application in planning processes such as those occurring in health sciences ; Quattrin et al. 2008 (3); Hjarno et al. 2007 (4); Griffith 2006 (5) or; Noordhuizen and Welpelo 1996 (6)), in natural resource management (US Forest Service 2014 a,b,c (7, 8, 9), (US EPA, 2006 (10); see alsohttp://www.waterboards.ca.gov/water_issues/programs/swamp/ais/prevention_planning.shtml; (last accessed October 16, 2023)or in supporting field operations wherein worker health and natural resource management issues intersect.1.2 HACCP evaluation is a simple linear process or a network of linear processes that represents the structure of any event; the hazard analysis (HA) depends on the data quality and data quantity available for the evaluation process, especially as that relates to critical control points (CCPs) characterized in completing HACCP. Control measures target CCPs and serve as limiting factors or control steps in a process that reduce or eliminate the hazards that initiated the HACCP evaluation. The main reason for implementing HACCP is to prevent problems associated with a specific process, practice, material, or product.1.3 This guide assumes that the reader is knowledgeable in specific resource management or engineering practices used as part of the HACCP process. A list of general references is provided for HACCP and implementation of HACCP and similar methods, as those apply to environmental hazard evaluation, natural resource management, and environmental engineering practices (11-26).1.4 This guide does not describe or reference detailed procedures for specific applications of HACCP, but describes how existing information or other empirical data should be used when assessing the hazards and identifying CCPs potentially of use in minimizing or eliminating specific hazards. Specific applications of HACCP evaluation are included as annexes to this guide, which include implementation of HACCP in resource management practices related to control and mitigation of invasive species or disease agents primarily of concern for managing fish and wildlife.1.5 HACCP evaluation has a well developed literature in, for example, food science and technology, and in engineering applications (see, for example, (11, 12, 13, 15, 17)). As a resource management tool, HACCP is relatively recent in application to the analysis of hazards to aquatic, wetland, and terrestrial habitats and the organisms occupying those habitats. (see, for example, US Forest Service 2014 a,b,c (7, 8, 9); see also http://www.haccp-nrm.org/ last accessed June 16, 2014). Most of the guidance provided herein is qualitative rather than quantitative, although quantitative methods should be applied to any hazard analysis when possible. Uncertainties associated with the analysis should also be characterized and incorporated into the HACCP evaluation when possible (see, for example, (11, 27-38)).1.6 This standard provides guidance for assessing hazard within a generalized framework that may be extended to specific environmental settings, such as that detailed in E1023 for aquatic habitats (Guide for Assessing the Hazard of a Material to Aquatic Organisms and Their Uses). This standard does not provide guidance on how to account for socio-economic or political considerations that influence the specification of the acceptability of risk associated with the hazard, particularly when HACCP is implemented and CCPs are considered within contemporary risk-based decision-making processes. Judgments concerning acceptability are outside the scope of this guide, but available guidance from ASTM is applicable to this process (see E2348 Standard Guide for Framework for a Consensus-based Environmental Decision-making Process).1.7 This guide is arranged as follows:  Section 1Referenced Documents 2Descriptions of Terms Specific to This Standard 3Summary of Guide 4 5Basic Concepts of HACCP and Detailed Characterization of HACCP 6HACCP Applied to Prevention and Control of Invasive Species Annex A1HACCP-Derived Decontamination Procedures Mitigating Equipment-Mediated Transfers of Invasive Aquatic Biota, Principally Mussel Species Annex A2HACCP-Derived Decontamination Procedures for Controlling Equipment-Mediated Transfers of Disease Agents of Aquatic Biota, Principally Infectious Amphibian Diseases Annex A31.8 This standard does not purport to address all of the safety concerns, if any, associated with its use and the implementation of HACCP. 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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1.1 This test method covers the determination of the test period of frost immunity of concrete specimens as measured by the length of time of water immersion required to produce critical dilation when subjected to a prescribed slow-freezing procedure. 1.2 The values stated in SI units are to be regarded as the standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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1.1 This practice covers the evaluation of frost resistance of coarse aggregates in air-entrained concrete. It was developed particularly for use with normal weight aggregates not having vesicular, highly porous structure.1.2 The values stated in inch-pound units are to be regarded as the standard.

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1.1 This practice describes the operation and production control of metal powder bed fusion (PBF) machines and processes to meet critical applications such as commercial aerospace components and medical implants. The requirements contained herein are applicable for production components and mechanical test specimens using powder bed fusion (PBF) with both laser and electron beams.1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 This test method provides a prediction of the resistance to stable propagating pitting corrosion of stainless steels and related alloys in a standard medium (see Note 1). The CPT test can be used for product acceptance, alloy development studies, and manufacturing control. In the case of product acceptance, the supplier and user must agree upon the preconditioning of the specimen with regard to surface finish. The test is not intended for design purposes since the test conditions accelerate corrosion in a manner that does not simulate any actual service environment.5.2 Another method to determine the potential independent CPT with an electrochemical technique has been discussed in the literature (1-4). This test method involves a potentiodynamic (potential sweep) procedure performed on specimens at different temperatures. A comparison (2) of the test method described in this test method and the potentiodynamic technique has indicated no difference in the test result obtained.1.1 This test method covers a procedure for the evaluation of the resistance of stainless steel and related alloys to pitting corrosion based on the concept of the determination of a potential independent critical pitting temperature (CPT).1.2 This test method applies to wrought and cast products including but not restricted to plate, sheet, tubing, bar, forgings, and welds, (see Note 1).NOTE 1: Examples of CPT measurements on sheet, plate, tubing, and welded specimens for various stainless steels can be found in Ref (1).2 See the research reports (Section 14).1.3 The standard parameters recommended in this test method are suitable for characterizing the CPT of austenitic stainless steels and other related alloys with a corrosion resistance ranging from that corresponding to solution annealed UNS S31600 (Type 316 stainless steel) to solution annealed UNS S31254 (6 % Mo stainless steel).1.4 This test method may be extended to stainless steels and other alloys related to stainless steel that have a CPT outside the measurement range given by the standard parameters described in this test method. Appropriate test potential and solution must then be determined.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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5.1 This test method is designed to provide a basis for estimating one aspect of the fire exposure behavior of exposed insulation installed on the floor of an open attic. The test environment is intended to simulate attic floor exposure to radiant heat conditions. Radiant heat has been observed and defined in full-scale attic experiments.1.1 This test method covers a procedure for measuring the critical radiant flux of exposed attic floor insulation subjected to a flaming ignition source in a graded radiant heat energy environment inside a test chamber. The test specimen can be any attic floor insulation. This test method is not applicable to those insulations that melt or shrink away when exposed to the radiant heat energy environment or the ignition source.1.2 This test method measures the critical radiant flux at the farthest point to which the flame advances. It provides a means for relative classification of a fire test response standard for exposed attic floor insulation. The imposed radiant flux simulation levels of thermal radiation are likely to impinge on the surface of exposed attic insulation from roof assemblies heated by the sun and by heat or flames of an incidental fire which has the potential to involve an attic space. This test method is intended to simulate an important element of fire exposure that has the potential to develop in open attics, but is not intended for use in describing flame spread behavior of insulation installed other than on an attic floor.1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.1.4 This standard is used to measure and describe the response of materials, products, or assemblies to heat and flame under controlled conditions, but does not by itself incorporate all factors required for fire hazard or fire risk assessment of the material, products, or assemblies under actual fire conditions.1.5 Warning—Fire testing is inherently hazardous. Adequate safeguards for personnel and property shall be employed in conducting these tests.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 is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone.4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.4.3 The user is encouraged to use appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs, respectively.4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.1.1 This guide covers general guidelines for the in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this guide are segmental critical size defects which, by definition, will not fill with viable tissue without treatment. Thus, these models represent a stringent test of a material’s ability to induce or augment bone growth.1.2 Guidelines include a description and rationale of various animal models including rat (murine), rabbit (leporine), dog (canine), goat (caprine), and sheep (ovine). Outcome measures based on radiographic, histologic, and mechanical analyses are described briefly and referenced. The user should refer to specific test methods for additional detail.1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in the Referenced Documents (Section 2).1.4 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.1.5 Other preclinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.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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1. Scope 1.1 The purpose of this Standard is to facilitate identification, by class, of drugs in syringes filled by the user that are used in anaesthesia and critical care. 1.2 This Standard specifies design requirements for the size, shape, patte

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1 Scope and object This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Particular Standard specifies the safety requirements for VENTILATORS, as defined in 2.1.125, intended for use in critical care settings. Co

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5.1 This fire test response standard is designed to provide a basis for estimating one aspect of the fire exposure behavior of a floor-covering system installed in a building corridor. The test environment is intended to simulate conditions that have been observed and defined in full scale corridor experiments.5.2 The test is intended to be suitable for regulatory statutes, specification acceptance, design purposes, or development and research.5.3 The fundamental assumption inherent in the test is that critical radiant flux is one measure of the sensitivity to flame spread of floor-covering systems in a building corridor.5.4 The test is applicable to floor-covering system specimens that follow or simulate accepted installation practice. Tests on the individual elements of a floor system are of limited value and not valid for evaluation of the flooring system.5.5 In this procedure, the specimens are subjected to one or more specific sets of laboratory test conditions. If different test conditions are substituted or the end-use conditions are changed, it is not always possible by or from this test method to predict changes in the fire-test-response characteristics measured. Therefore, the results are valid only for the fire test exposure conditions described in this procedure.1.1 This fire-test-response standard covers a procedure for measuring the critical radiant flux of horizontally mounted floor-covering systems exposed to a flaming ignition source in a graded radiant heat energy environment in a test chamber. A specimen is mounted over underlayment, a simulated concrete structural floor, bonded to a simulated structural floor, or otherwise mounted in a typical and representative way.1.2 This fire-test-response standard measures the critical radiant flux at flame-out. It provides a basis for estimating one aspect of fire exposure behavior for floor-covering systems. The imposed radiant flux simulates the thermal radiation levels likely to impinge on the floors of a building whose upper surfaces are heated by flames or hot gases, or both, from a fully developed fire in an adjacent room or compartment. The standard was developed to simulate an important fire exposure component of fires that develop in corridors or exitways of buildings and is not intended for routine use in estimating flame spread behavior of floor covering in building areas other than corridors or exitways. See Appendix X1 for information on proper application and interpretation of experimental results from use of this test.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 The text of this standard references notes and footnotes that provide explanatory information. These notes and footnotes, excluding those in tables and figures, shall not be considered as requirements of this standard.1.5 This standard is used to measure and describe the response of materials, products, or assemblies to heat and flame under controlled conditions but does not by itself incorporate all factors required for fire-hazard or fire-risk assessment of materials, products, or assemblies under actual fire conditions.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.Specific hazard statements are given in Section 7.1.7 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 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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5.1 This fire-test-response standard is designed to provide a basis for estimating one aspect of the fire exposure behavior to exposed insulation installed on the floors of building attics. The test environment is intended to simulate conditions that have been observed and defined in full-scale attic experiments.5.2 The test is intended to be suitable for regulatory statutes, specification acceptance, design purposes, or development and research.5.3 The fundamental assumption inherent in the test is that critical radiant flux is one measure of the surface burning characteristics of exposed insulation on floors or between joists of attics.5.4 The test is applicable to attic floor insulation specimens that follow or simulate accepted installation practice.5.5 In this procedure, the specimens are subjected to one or more specific sets of laboratory fire test exposure conditions. If different test conditions are substituted or the anticipated end-use conditions are changed, caution should be used to predict changes in the performance characteristics measured by or from this test. Therefore, the results are strictly valid only for the fire test exposure conditions described in this procedure.5.5.1 If the test results obtained by this test method are to be considered in the total assessment of fire hazard in a building structure, then all pertinent established criteria for fire hazard assessment developed by Committee E-5 must be included in the consideration.1.1 This fire-test-response standard describes a procedure for measuring the critical radiant flux of exposed attic floor insulation subjected to a flaming ignition source in a graded radiant heat energy environment in a test chamber. The specimen is any attic floor insulation. This test method is not applicable to those insulations that melt or shrink away when exposed to the radiant heat energy environment or the pilot burner.1.2 This fire-test-response standard measures the critical radiant flux at the point at which the flame advances the farthest. It provides a basis for estimating one aspect of fire exposure behavior for exposed attic floor insulation. The imposed radiant flux simulates the thermal radiation levels likely to impinge on the floors of attics whose upper surfaces are heated by the sun through the roof or by flames from an incidental fire in the attic. This fire-test-response standard was developed to simulate an important fire exposure component of fires that develop in attics, but is not intended for use in estimating flame spread behavior of insulation installed other than on the attic floor.1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.1.4 The text of this standard references notes and footnotes that provide explanatory information. These notes and footnotes, excluding those in tables and figures, shall not be considered as requirements of this standard.1.5 This standard is used to measure and describe the response of materials, products, or assemblies to heat and flame under controlled conditions, but does not by itself incorporate all factors required for fire hazard or fire risk assessment of the materials, products, or assemblies under actual fire conditions.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 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the 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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1.1 This test method determines the minimum internal air pressure at which rapid crack propagation (RCP) can be sustained along a section of plastic pipe. This is termed the critical pressure.1.2 This technique achieves steady state RCP in a small specimen by restraining the decompression which normally accompanies fracture, and therefore indicates a lower critical pressure than that measured on the same pipe using full-scale tests. This test method has been called "Small Scale Steady State" or S4.1.3 This test method was developed for polyethylene pipe, and has been shown to correlate with the full-scale RCP test method. The user should determine if it is applicable to other plastic piping methods.1.4 The values stated in inch-pound units are to be regarded as the standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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