1.1 This specification covers requirements, test methods, materials, and marking for closed-cell cellular polypropylene (PP), open bottom, buried chambers of corrugated wall construction used for collection, detention, and retention of stormwater runoff. Applications include commercial, residential, agricultural, and highway drainage, including installation under parking lots and roadways.1.2 Chambers are produced in arch shapes with dimensions based on chamber rise, chamber span, and wall stiffness. Chambers are manufactured with integral feet that provide base support. Perforations to enhance water flow are permitted. Chambers must meet test requirements for arch stiffness, and flattening. Chamber end caps shall be produced of PP or polyethylene (PE) by a suitable manufacturing process provided that all other product requirements in this standard are met.1.3 Analysis and experience have shown that the successful performance of this product depends upon the type and depth of bedding and backfill, and care in installation. This specification includes requirements for the manufacturer to provide chamber installation instructions to the purchaser.1.4 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.1.5 This standard does not purport to address water quality issues or hydraulic performance requirements associated with its use. It is the responsibility of the user to ensure that appropriate engineering analysis is performed to evaluate the water quality issues and hydraulic performance requirements for each installation.1.6 The following safety hazards caveat pertains only to the test method portion, Section 6, of this specification: 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 The calculated error in the photovoltaic device current determined from the spectral mismatch parameter can be used to determine if a measurement will be within specified limits before the actual measurement is performed.5.2 The spectral mismatch parameter also provides a means of correcting the error in the measured device current due to spectral mismatch.5.2.1 The spectral mismatch parameter is formulated as the fractional error in the short-circuit current due to spectral and temperature differences.5.2.2 Error due to spectral mismatch is corrected by multiplying a reference cell’s measured short-circuit current by M , a technique used in Test Methods E948 and E1036.5.3 Because all spectral quantities appear in both the numerator and the denominator in the calculation of the spectral mismatch parameter (see 8.1), multiplicative calibration errors cancel, and therefore only relative quantities are needed (although absolute spectral quantities may be used if available).5.4 Temperature-dependent spectral mismatch is a more accurate method to correct photovoltaic current measurements compared with fixed-value temperature coefficients.31.1 This test method provides a procedure for the determination of a spectral mismatch parameter used in performance testing of photovoltaic devices.1.2 The spectral mismatch parameter is a measure of the error introduced in the testing of a photovoltaic device that is caused by the photovoltaic device under test and the photovoltaic reference cell having non-identical quantum efficiencies, as well as mismatch between the test light source and the reference spectral irradiance distribution to which the photovoltaic reference cell was calibrated.1.2.1 Examples of reference spectral irradiance distributions are Tables E490 or G173.1.3 The spectral mismatch parameter can be used to correct photovoltaic performance data for spectral mismatch error.1.4 Temperature-dependent quantum efficiencies are used to quantify the effects of temperature differences between test conditions and reporting conditions.1.5 This test method is intended for use with linear photovoltaic devices in which short-circuit is directly proportional to incident irradiance.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.4.2 This guide can be used by the following types of users:4.2.1 Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials.4.2.2 Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials.4.2.3 Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials.4.3 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound and hemostatic dressings, surgical implants or injectables (including in-situ forming), hybrid medical devices, TEMPs, injectable (including in-situ forming) or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in-vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of polymerizable collagens and collagen polymeric materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any specific research or medical application.4.4 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of polymerizable collagen, impurities profile, and comprehensive chemical, physical, and biological characterization and testing.4.5 The following documents or other relevant guidance documents from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of devices, biologics, drugs, and combination products should be considered when determining if the collagen supplied satisfies requirements for use in medical and research products, including TEMPs, therapeutic delivery vehicles, and 3D in-vitro tissue systems:FDA CFR:21 CFR 3: Product Jurisdiction: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=321 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=58 FDA/CDRH CFR and Guidances:21 CFR Part 803: Medical Device Reporting: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=80321 CFR 812: Investigational Device Exemptions: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=81221 CFR 814: Premarket Approval of Medical Devices: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=81421 CFR 820: Quality System Regulation: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=820Design Control Guidance for Medical Device Manufacturers: http://www.fda.gov/cdrh/comp/designgd.pdfPreproduction Quality Assurance Planning Recommendations for Medical Device Manufacturers (FDA 90-4236): http://www.fda.gov/cdrh/manual/appende.htmlThe Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program—Draft Guidance for Industry and FDA Staff: http://www.fda.gov/cdrh/comp/guidance/1602.pdf FDA/CDRH Search Engines:CDRH Guidance Search Engine: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/ search.cfmCDRH Premarket Approval (PMA) Search Engine: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/ pma.cfmCDRH 510(k) Search Engine: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/ pmn.cfmCDRH Recognized STANDARDS Search Engine: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ search.cfm FDA/CBER CFR and Guidances:21 CFR 312: Investigational New Drug Application: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=31221 CFR 314: Applications for FDA Approval to Market a New Drug: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=3121 CFR 610: General Biological Products Standards: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=61021 CFR 1271: Human Cells, Tissues and Cellular and Tissue-Based Products: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=1271Cellular & Gene Therapy Guidances and Other Publications: http://www.fda.gov/cber/genetherapy/gtpubs.htmHuman Tissue Guidances and Other Publications: http://www.fda.gov/cber/tissue/docs.htmCBER Product Approval Information: http://www.fda.gov/cber/efoi/approve.htm21 CFR 600, 601 BLA Regulations: http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfrv7_07.html21 CFR 210, 211 GMP Regulations: http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr210_07.html1.1 This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.1.2 This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produced through in vitro cell culture, with or without using recombinant technology; and (3) chemically synthesized collagen mimetic peptides. It should be noted that the format of collagen polymeric material products also will vary and may include injectable solutions that polymerize in situ as well as preformed sheets, particles, spheres, fibers, sponges, matrices/gels, coatings, films, and other forms.1.2.3 This guide may serve as a template for characterization and standardization of type I fibrillar collagen or other collagen types that demonstrate polymerization or self-assembly.1.3 This guide does not provide a significant basis for assessing the biological safety (biocompatibility) of polymerizable collagens and collagen polymeric materials. While the ability of collagen polymeric materials to guide cellular responses through provision of cellular adhesion and proteolytic domains as well as physical constraints (for example, structural, cell-matrix traction force) has been well documented through extensive clinical and basic research studies (1-5),2 users are directed to the ISO 10993 series for evaluating biological risks of medical devices. The biocompatibility and appropriateness of use for a specific application is the responsibility of the product manufacturer.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 The following precautionary caveat pertains only to the test method portion, Sections 6 and 7, of this guide: 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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5.1 Knowledge of migrants from plastic materials may serve many useful purposes, such as testing for compliance with food additive regulations. The procedure described in this test method is recommended as suitable for obtaining such data on many migrant(s)/plastic(s) combinations.1.1 This test method covers the use of the FDA migration cell in the extraction of components and permits quantitation of individual migrants from plastic materials by suitable extracting liquids, including liquid foods and food-stimulating solvents.1.2 This test method provides a two-sided, liquid extraction test for plastic materials that can be formed into film, sheet, or disks.1.3 This test method has been applied to a variety of migrant/polymer systems in contact with numerous foods and food simulants.2 Though most of the migrants examined were radiolabeled, the use of the FDA cell has been validated for migration studies of unlabeled sytrene from polystyrene.31.4 This test method has been shown to yield reproducible results under the conditions for migration tests requested by the FDA. However, if the data is to be submitted to the FDA, it is suggested that their guidelines be consulted.1.5 Because it employs two-sided extraction, this test method may not be suitable for multi-layered plastics intended for single-sided food contact use.1.6 The size of the FDA migration cell as described may preclude its use in determining total nonvolatile extractives in some cases.NOTE 1: For more information, see Practice D1898, the AOAC Methods of Analysis on Flexible Barrier Materials Exposed for Extraction, and the Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, December 2007.1.7 Analytical procedures must be available to quantitate the migrant(s) generated by this test method.1.8 The values stated in SI units are to be regarded as the standard.1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific hazards statements are given in Section 8.NOTE 2: There is no known ISO equivalent to this test method.1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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5.1 Rigid gas-filled closed-cell foam insulations include all cellular plastic insulations which rely on a blowing agent (or gas), other than air, for thermal resistance values. At the time of manufacture, the cells of the foam usually contain their highest percentage of blowing agent and the lowest percentage of atmospheric gases. As time passes, the relative concentrations of these gases change due primarily to diffusion. This results in a general reduction of the thermal resistance of the foam due to an increase in the thermal conductivity of the resultant cell gas mixture. These phenomena are typically referred to as foam aging.5.1.1 For some rigid gas-filled closed-cell foam insulation products produced using blowing agent gases that diffuse very rapidly out of the full-thickness foam product, such as expanded polystyrene, there is no need to accelerate the aging process.5.1.2 Physical gas diffusion phenomena occur in three dimensions. The one-dimensional form of the diffusion equations used in the development of this practice are valid only for planar geometries, that is, for specimens that have parallel faces and where the thickness is much smaller than the width and much smaller than the length.NOTE 3: Please see Appendix X3 for a discussion of the theory of accelerated aging via thin slicing.NOTE 4: Theoretical and experimental evaluations of the aging of insulation in radial forms, such as pipe insulation, have been made. (6) However, these practices have not evolved to the point of inclusion in the test standard.5.2 The change in thermal resistance due to the phenomena described in 5.1 usually occurs over an extended period of time. Information regarding changes in the thermal resistance of these materials as a function of time is required in a shorter period of time so that decisions regarding formulations, production, and comparisons with other materials can be made.5.3 Specifications C578, C591, C1029, C1126 and C1289 on rigid closed-cell foams measure thermal resistance after conditioning at 23 ± 1°C [73 ± 2°F] for 180 ± 5 days from the time of manufacture or at 60 ± 1°C [140 ± 2°F] for 90 days. This conditioning can be used for comparative purposes, but is not sufficient to describe long-term thermal resistance. This requirement demonstrates the importance of the aging phenomena within this class of products.5.4 The Prescriptive Method in Part A provides long-term thermal resistance values on a consistent basis for a variety of purposes, including product evaluation, specifications, or product comparisons. The consistent basis for these purposes is provided by a series of specific procedural constraints, which are not required in the Research Method described in Part B. The values produced by the Prescriptive Method correspond to the thermal resistance at an age of five years, which corresponds closely to the average thermal resistance over a 15-year service life (7, 8).5.4.1 It is recommended that any material standard that refers to C1303 to provide a product rating for long-term thermal resistance specify the Part A Test Method of C1303.5.5 The Research Method in Part B provides a relationship between thermal conductivity, age, and product thickness. The calculation methods given in Part B can be used to predict the resistance at any specific point in time as well as the average resistance over a specific time period.NOTE 5: The 5-year aged values produced in Part A can be derived from the Part B data only if all other Part A requirements are met.5.6 This test method addresses three separate elements relating to the aging of rigid closed-cell plastic foams.5.6.1 Specimen Preparation—Techniques for the preparation of thin flat specimens, including their extraction from the “as manufactured” product, and the measurement of specimen thickness are discussed.5.6.2 Measurement of the Thermal Resistance—Thermal resistance measurements, taken at scheduled times, are an integral part of the test method.5.6.3 Interpretation of Data—Procedures are included to properly apply the theory and techniques to achieve the desired goals.1.1 This test method covers a procedure for predicting the long-term thermal resistance (LTTR) of unfaced or permeably faced rigid gas-filled closed-cell foam insulations by reducing the specimen thickness to accelerate aging under controlled laboratory conditions (1-5) .2NOTE 1: See Terminology, 3.2.1, for the meaning of the word aging within this standard.1.2 Rigid gas-filled closed-cell foam insulation includes all cellular plastic insulations manufactured with the intent to retain a blowing agent other than air.1.3 This test method is limited to unfaced or permeably faced, homogeneous materials. This method is applied to a wide range of rigid closed-cell foam insulation types, including but not limited to: extruded polystyrene, polyurethane, polyisocyanurate, and phenolic. This test method does not apply to impermeably faced rigid closed-cell foams or to rigid closed-cell bun stock foams.NOTE 2: See Note 8 for more details regarding the applicability of this test method to rigid closed-cell bun stock foams.1.4 This test method utilizes referenced standard test procedures for measuring thermal resistance. Periodic measurements are performed on specimens to observe the effects of aging. Specimens of reduced thickness (that is, thin slices) are used to shorten the time required for these observations. The results of these measurements are used to predict the long-term thermal resistance of the material.1.5 The test method is given in two parts. The Prescriptive Method in Part A provides long-term thermal resistance values on a consistent basis that can be used for a variety of purposes, including product evaluation, specifications, or product comparisons. The Research Method in part B provides a general relationship between thermal conductivity, age, and product thickness.1.5.1 To use the Prescriptive Method, the date of manufacture must be known, which usually involves the cooperation of the manufacturer.1.6 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.1.7 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 Table of Contents: Section 1Reference Documents 2Terminology 3Summary of Test Method 4 5Part A: The Prescriptive Method 6 Applicability 6.1 Qualification Requirements 6.1.1 Facing Permeability 6.1.2 Apparatus 6.2 Sampling 6.3 Schedule 6.3.1 Specimen Preparation 6.4 Goal 6.4.1 Schedule 6.4.2 Replicate Test Specimen Sets 6.4.3 Specimen Extraction 6.4.4 Slice Flatness 6.4.5 Slice Thickness 6.4.6 Stack Composition 6.4.7 Storage Conditioning 6.5 Test Procedure 6.6 Thermal Resistance Measurement Schedule 6.6.1 Thermal Resistance Measurements 6.6.2 Product Density 6.6.3 Calculations 6.7Part B: The Research Method 7 Background 7.1 TDSL Apparatus 7.2 Sampling Schedule 7.3 Specimen Preparation 7.4 Storage Conditioning 7.5 Test Procedure 7.6 Calculations 7.7Reporting 8 Reporting for Part A, the Prescriptive Method 8.1 Reporting for Part B, the Research Method 8.2Precision and Bias 9Keywords 10Mandatory Information – Qualification Annex A1 Specimen Preparation A1.1 Homogeneity Qualification A1.2Thermal Conductivity Equivalence Test Procedure A1.3 Alternate Product Thickness Qualification A1.4Example Calculations A1.5Mandatory Information-Preparation of Test Specimens for Spray-Foam Products Annex A2Effect Of TDSL Appendix X1History of the Standard Appendix X2Theory of Foam Aging Appendix X3References 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 specification covers preformed expansion joint fillers made from closed-cell polyolefin materials having suitable compressibility and nonextruding characteristics.1.1.1 Type I, closed-cell polyethylene or blended polyethylene.1.2 These joint fillers are intended for use in concrete pavements in full-depth joints. There are several variations in size. A typical size measures 0.5 in. (12.7 mm) in thickness, 4.0 in. (101.6 mm) in width, and 10 ft (3.048 m) in length and will relieve stress or avoid potential distress in adjacent structures or pavements.1.3 The values stated in inch-pound units are to be regarded as the standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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5.1 Overview of Measurement System—Relative intensity measurements made by widefield epifluorescence microscopy are used as part of cell-based assays to quantify attributes such as the abundance of probe molecules (see ASTM F2997), fluorescently labeled antibodies, or fluorescence protein reporter molecules. The general procedure for quantifying relative intensities is to acquire digital images, then to perform image analysis to segment objects and compute intensities. The raw digital images acquired by epifluorescence microscopy are not typically amenable to relative intensity quantification because of the factors listed in 4.2. This guide offers a checklist of potential sources of bias that are often present in fluorescent microscopy images and suggests approaches for storing and normalizing raw image data to assure that computations are unbiased.5.2 Areas of Application—Widefield fluorescence microscopy is frequently used to measure the location and abundance of fluorescent probe molecules within or between cells. In instances where RIM comparisons are made between a region of interest (ROI) and another ROI, accurate normalization procedures are essential to the measurement process to minimize biased results. Example use cases where this guidance document may be applicable include:5.2.1 Characterization of cell cycle distribution by quantifying the abundance of DNA in individual cells (1).75.2.2 Measuring the area of positively stained mineralized deposits in cell cultures (ASTM F2997).5.2.3 Quantifying the spread area of fixed cells (ASTM F2998).5.2.4 Determining DNA damage in eukaryotic cells using the comet assay (ASTM E2186).5.2.5 The quantitation of a secondary fluorescent marker that provides information related to the genotype, phenotype, biological activity, or biochemical features of a colony or cell (ASTM F2944).1.1 This guidance document has been developed to facilitate the collection of microscopy images with an epifluorescence microscope that allow quantitative fluorescence measurements to be extracted from the images. The document is tailored to cell biologists that often use fluorescent staining techniques to visualize components of a cell-based experimental system. Quantitative comparison of the intensity data available in these images is only possible if the images are quantitative based on sound experimental design and appropriate operation of the digital array detector, such as a charge coupled device (CCD) or a scientific complementary metal oxide semiconductor (sCMOS) or similar camera. Issues involving the array detector and controller software settings including collection of dark count images to estimate the offset, flat-field correction, background correction, benchmarking of the excitation lamp and the fluorescent collection optics are considered.1.2 This document is developed around epifluorescence microscopy, but it is likely that many of the issues discussed here are applicable to quantitative imaging in other fluorescence microscopy systems such as fluorescence confocal microscopy. This guide is developed around single-color fluorescence microscopy imaging or multi-color imaging where the measured fluorescence is spectrally well separated.1.3 Fluorescence intensity is a relative measurement and does not in itself have an associated SI unit. This document does discuss metrology issues related to relative measurements and experimental designs that may be required to ensure quantitative fluorescence measurements are comparable after changing microscope, sample, and lamp configurations.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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