4.1 After a model has been calibrated and used to draw conclusions about a physical hydrogeologic system (for example, estimating the capture zone of a proposed extraction well), a sensitivity analysis can be performed to identify which model inputs have the most impact on the degree of calibration and on the conclusions of the modeling analysis.4.2 If variations in some model inputs result in insignificant changes in the degree of calibration but cause significantly different conclusions, then the mere fact of having used a calibrated model does not mean that the conclusions of the modeling study are valid.4.3 This guide is not meant to be an inflexible description of techniques of performing a sensitivity analysis; other techniques may be applied as appropriate and, after due consideration, some of the techniques herein may be omitted, altered, or enhanced.1.1 This guide covers techniques that should be used to conduct a sensitivity analysis for a groundwater flow model. The sensitivity analysis results in quantitative relationships between model results and the input hydraulic properties or boundary conditions of the aquifers.1.2 After a groundwater flow model has been calibrated, a sensitivity analysis may be performed. Examination of the sensitivity of calibration residuals and model conclusions to model inputs is a method for assessing the adequacy of the model with respect to its intended function.1.3 After a model has been calibrated, a modeler may vary the value of some aspect of the conditions applying solely to the prediction simulations in order to satisfy some design criteria. For example, the number and locations of proposed pumping wells may be varied in order to minimize the required discharge. Insofar as these aspects are controllable, variation of these parameters is part of an optimization procedure, and, for the purposes of this guide, would not be considered to be a sensitivity analysis. On the other hand, estimates of future conditions that are not controllable, such as the recharge during a postulated drought of unknown duration and severity, would be considered as candidates for a sensitivity analysis.1.4 This guide presents the simplest acceptable techniques for conducting a sensitivity analysis. Other techniques have been developed by researchers and could be used in lieu of the techniques in this guide.1.5 This guide is written for performing sensitivity analyses for groundwater flow models. However, these techniques could be applied to other types of groundwater related models, such as analytical models, multi-phase flow models, non-continuum (karst or fracture flow) models, or mass transport models.1.6 This guide is one of a series on groundwater modeling codes (software) and their applications, such as Guide D5447 and Guide D5490. Other standards have been prepared on environmental modeling, such as Practice E978.1.7 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 and health practices and determine the applicability of regulatory limitations prior to use.1.9 This guide offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project's many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.

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5.1 Internal—The EMPM provides assessment results that are easy to understand and communicate. Areas requiring additional resources become apparent, and thus, can be more readily addressed. Improvement can be tracked in meaningful ways. Assessment detail allows attention to be drawn to processes of exceptional maturity and areas in which changes or additional resources, or both, are required to achieve process improvements.5.2 External—Meaningful comparisons to external requirements are enabled. Comparisons of equipment management between entities in different operational or business environments become meaningful and provide insight previously unavailable.1.1 This practice covers a process for the assessment and reporting of an entity’s overall equipment management process maturity (EMPM).1.2 The highest value is placed on continuous improvement as reflected in measured increases in maturity over time.1.3 The EMPM model is designed to be applicable and appropriate for all equipment-holding entities, however, the EMPM may not be the only acceptable assessment model available.1.4 It includes all aspects of equipment management.1.5 In addition to applicability to equipment and equipment management as defined in this practice, this practice may in whole or in part be effectively applied to intangible property, real property, and material.1.6 There is great variation across organizations regarding the internal departments that accomplish the various aspects of equipment management. Thus, all criteria are not applicable to all entities.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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5.1 In the battle to reduce medical device and implant-related infections, prevention of bacterial colonization of surfaces is a logical strategy. Bacterial colonization of a surface is a precursor to biofilm formation. Biofilm is the etiological agent of many implant and device-related infections and once established, microorganisms in biofilm can be up to 1000 times more tolerant to antibiotic therapy. Often the best treatment strategy is removal of the implant or device at a high socioeconomic cost. Catheter associated urinary tract infections (CAUTI) are the most prevalent of the device-related healthcare associated infections. Catheter associated infections account for 37 % of all hospital acquired infections (HAI) and 70 % of all nosocomial urinary tract infections (UTI) in the U.S. (2, 3). The Intraluminal Catheter Model (ICM) was developed to evaluate the ability of antimicrobial catheters to inhibit biofilm growth on the catheter lumen.5.2 The purpose of this test method is to direct a user in how to grow, sample, and analyze an E. coli biofilm in a urinary catheter under a constant flow of artificial urine. The test method incorporates operational parameters utilized in similar published methods (4). The E. coli biofilm that grows has a patchy appearance that varies across the catheter. Microscopically, the biofilm is heterogenous, with large clusters in some areas, and flat sheets of cells or even single cells in others. By 24 h, the biofilm is developed in the control catheters. If the goal is to monitor early stage biofilm development, then tubing and effluent samples need to be collected prior to the 24 h sample collection. Monitoring biofilm development requires sampling. The biofilm generated in the Intraluminal Catheter Model is suitable for comparison testing between antimicrobial and control catheters.1.1 This test method specifies the operational parameters required to assess the ability of antimicrobial urinary catheters to prevent or control biofilm growth. Efficacy is reported as the log reduction in viable bacteria when compared to a repeatable (1)2 Escherichia coli biofilm grown in the intra-lumen of a urinary catheter under a constant flow of artificial urine.1.2 The test method is versatile and may also be used for growing and/or characterizing biofilms and suspended bacteria of different species, although this will require changing the operational parameters to optimize the method based upon the growth requirements of the new organism.1.3 This test method may be used to evaluate surface modified urinary catheters that contain no antimicrobial agent.1.4 This test method describes how to sample and analyze catheter segments and effluent for viable cells. Biofilm population density is recorded as log colony forming units per surface area. Suspended bacterial population density is reported as log colony forming units per volume.1.5 Basic microbiology training is required to perform this test method.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard1.7 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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5.1 The procedures in this practice support the determination of the burn hazard potential for a heated surface. These procedures provide an estimate of the maximum skin contact temperature and must be used in conjunction with Guide C1055 to evaluate the surface hazard potential.5.2 The two procedures outlined herein are both based upon the same heat transfer principles. Method A uses a mathematical model to predict the contact temperature, while Method B uses a plastic rubber probe having similar heat transfer characteristics to the human finger to “measure” the contact temperature on real systems.5.3 These procedures serve as an estimate for the skin contact temperatures which might occur for the “average” individual. Unusual conditions of exposure, incorrect design assumptions, subject health conditions, or unforeseen operating conditions will potentially negate the validity of the estimations.5.4 These procedures are limited to direct contact exposure only. Conditions of personal exposure to periods of high ambient temperatures, direct flame exposure, or high radiant fluxes will potentially cause human injury in periods other than determined herein. Evaluation of exposures other than direct contact are beyond the scope of this practice.5.5 Cold Surface Exposure—No consensus criteria exists for the destruction of skin cells by freezing. If, at some future time, such criteria are developed, extrapolation of the techniques presented here will serve as a basis for cold surface exposure evaluation.1.1 This practice covers a procedure for evaluating the skin contact temperature for heated surfaces. Two complimentary procedures are presented. The first is a purely mathematical approximation that is used during design or for worst case evaluation. The second method describes the thermesthesiometer, an instrument that analogues the human sensory mechanism and is only used on operating systems.NOTE 1: Both procedures listed herein are intended for use with Guide C1055. When used in conjunction with that guide, these procedures can determine the burn hazard potential for a heated surface.1.2 A bibliography of human burn evaluation studies and surface hazard measurement is provided in the References at the end of Guide C1055. Thermesthesiometer and mathematical modeling references are provided in the References at the end of this practice (1-5).21.3 This practice addresses the skin contact temperature determination for passive heated surfaces only. The analysis procedures contained herein are not applicable to chemical, electrical, or other similar hazards that provide a heat generation source at the location of contact.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines, intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. This specification is based on the guideline elements model version 2 (GEM II) created at the Yale Center for Medical Informatics by health services researchers and informatics specialists, and designed to serve as a comprehensive XML-based guideline document representation.1.1 This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines. This specification is intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. It can be used to represent document content throughout the entire guideline life cycle. Information at both high and low levels of abstraction can be accommodated. This specification is based on the guideline elements model (GEM) created at the Yale Center for Medical Informatics and designed to serve as a comprehensive XML-based guideline document representation.1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C.1.3 Standard Guideline Schema—This specification defines a standard Schema for clinical practice guidelines. The Schema is included in Annex A1.1.4 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 and health practices and determine the applicability of regulatory requirements prior to use.

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4.1 Intended Use: 4.1.1 This guide may be used by various parties involved in sediment corrective action programs, including regulatory agencies, project sponsors, environmental consultants, toxicologists, risk assessors, site remediation professionals, environmental contractors, and other stakeholders.4.2 Updates to CSM: 4.2.1 The CSM should be updated as needed and refined to describe the physical properties, chemical composition and occurrence, biological features, and environmental conditions of the sediment corrective action project (Guide E1689).4.3 Reference Material: 4.3.1 This guide should be used in conjunction with other ASTM guides listed in 2.1 (especially Guides E3163, E3164, E3240, E3242, and E3344), as well as the material in the References section (including (1)).4.4 Flexible Site-Specific Implementation: 4.4.1 This guide provides a systematic but flexible framework to accommodate variations in approaches by regulatory agencies and by the user based on project objectives, site complexity, unique site features, regulatory requirements, newly developed guidance, newly published scientific research, changes in regulatory criteria, advances in scientific knowledge and technical capability, and unforeseen circumstances.4.5 Regulatory Frameworks: 4.5.1 This guide is intended to be applicable to a broad range of local, state, tribal, federal, or international jurisdictions, each with its own unique regulatory framework. As such, this guide does not provide a detailed discussion of the requirements or guidance associated with any of these regulatory frameworks, nor is it intended to supplant applicable regulations and guidance. The user of this guide will need to be aware of the regulatory requirements and guidance in the jurisdiction where the work is being performed.4.6 Systematic Project Planning and Scoping Process: 4.6.1 When applying this guide, the user should undertake a systematic project planning and scoping process to collect information to assist in making site-specific, user-defined decisions for a particular project, including assembling an experienced team of project professionals. These practitioners should have the appropriate expertise to scope, plan, and execute a sediment data acquisition and analysis program. This team may include, but is not limited to, project sponsors, environmental consultants, toxicologists, site remediation professionals, analytical chemists, geochemists, and statisticians.4.7 Other Considerations: 4.7.1 This guide does not provide a detailed description of all topics of a program to derive representative sediment background concentrations. It is meant to be used in conjunction with other guides (such as Guides E3163, E3164, E3240, E3242, and E3344) to do so.4.7.2 Sediment sampling and laboratory analyses are not covered in detail in this guide. Guides E3163 and E3164 contain extensive information concerning sediment sampling and laboratory analysis methodologies.4.7.3 Data quality objectives are not covered in this guide. Data quality objectives are described in (2).4.7.4 The selection of a background reference area(s) is not covered in detail in this guide but is extensively described in Guide E3344.4.7.5 Background study design considerations are not covered in detail in this guide, but are extensively described in other references, including Guide E3164 and (3).4.7.6 The use of data evaluation methodologies to obtain representative background data sets from candidate background data sets is not covered in detail in this guide but is discussed in more depth in Guide E3242.4.7.6.1 Identification and removal of high nondetect values from candidate background data sets are discussed in detail in Guide E3242.4.7.6.2 Identification and removal of outliers from candidate background data sets are discussed in detail in Practice E178, as well as Guide E3242.4.7.6.3 Geochemical methodologies used in evaluating candidate background data sets to obtain representative background data sets are discussed in detail in Guide E3242; their applications during reference-area selection are discussed in Guide E3344.4.7.6.4 Chemical forensics methodologies used in evaluating candidate background data sets to obtain representative background data sets are discussed in detail in Guide E3242; their applications during reference-area selection are discussed in Guide E3344.4.7.7 The use of statistical methods to calculate BTVs from representative background data sets and to compare such data sets to the site data sets are discussed in detail in Guide E3242.4.7.8 Geospatial analysis considerations are not thoroughly discussed in this guidance but are discussed in more depth relative to environmental evaluations in (4), which focuses on quality assurance concerns relative to geospatial analyses.4.7.9 In this guide, “sediment” (3.1.16) is defined as a matrix being found at the bottom of a water body. Upland soils of sedimentary origin are excluded from consideration as sediment in this guide.4.7.10 In this guide, only COC concentrations are considered. Residual background radioactivity is out of scope for this guide.4.8 Structure and Components of This Guide: The user of this guide should review the overall structure and components of this guide before proceeding with use, including:• Section 1 • Section 2 Referenced Documents• Section 3 Terminology• Section 4 • Section 5 Overview of Representative Background Concentrations• Section 6 Framework for Developing Representative Background Concentrations for Sediment Sites• Section 7 Conceptual Site Model Considerations When Developing Representative Background Concentrations for Sediment Sites• Section 8 Keywords• References  1.1 This guide provides an overarching framework for the development of representative sediment background concentrations at contaminated sediment sites. It is intended to inform, complement, and support but not supersede the guidelines established by local, state, tribal, federal, or international agencies.1.2 Technically defensible representative sediment background concentrations are critical for several purposes (Guide E3242) (1)2. These include sediment site delineation, establishing remedial goals, remedy selection, assessment of risks posed by representative background concentrations, and establishing appropriate post-remedial monitoring plans.1.3 As part of the overall framework presented in this guide, Guide E3240 provides a general discussion of how Conceptual Site Model (CSM) development fits into the risk-based corrective action framework for contaminated sediment sites. However, not all elements of a sediment CSM need to be considered when developing representative sediment background concentrations; those that do are discussed in detail in Section 7 of this guide.1.3.1 As additional data are collected and analyzed, the CSM should be updated as needed.1.3.2 This guide is related to several other guides. Guide E3344 describes how to select an appropriate background reference area(s). Guide E3164 covers the sampling methodologies used in the field to obtain sediment samples (whether from the sediment site or background reference area[s]), and Guide E3163 discusses appropriate laboratory methodologies to use for the chemical analysis of potential contaminants of concern (PCOCs) in sediment samples. Guide E3242 describes how to evaluate candidate background data to obtain representative background data sets (including statistical, geochemical, and forensic considerations) and then how to use them to calculate representative sediment background concentrations. Relevant content contained in Guides E3163, E3164, E3242, and E3344 is summarized herein, but the individual guides should be consulted for more detailed coverage of these topics.1.4 Representative sediment background concentrations are typically used in contaminated sediment corrective actions performed under various regulatory programs, including the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Although many of the references cited in this guide are CERCLA oriented, the guide is applicable to corrective actions performed under local, state, tribal, federal, and international corrective action programs. However, this guide does not provide a detailed description of the requirements or existing background guidance for each jurisdiction.1.5 This guide would optimally be applied at the start of any sediment corrective action program but can be initiated at other points in the program as well.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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