07.100.01 微生物学综合 标准查询与下载

ASTM F2944-20 自动菌落形成装置（CFU）分析的标准实施规程培养中细胞和菌落计数和表征的图像采集和分析方法

1.1 This practice, provided its limitations are understood, describes a procedure for quantitative measurement of the number and biological characteristics of colonies derived from a stem cell or progenitor population using image analysis. 1.2 This practice is applied in an in vitro laboratory setting. 1.3 This practice utilizes: (a) standardized protocols for image capture of cells and colonies derived from in vitro processing of a defined population of starting cells in a defined field of view (FOV), and (b) standardized protocols for image processing and analysis. 1.4 The relevant FOV may be two-dimensional or threedimensional, depending on the CFU assay system being interrogated. 1.5 The primary unit to be used in the outcome of analysis is the number of colonies present in the FOV. In addition, the characteristics and sub-classification of individual colonies and cells within the FOV may also be evaluated, based on extant morphological features, distributional properties, or properties elicited using secondary markers (for example, staining or labeling methods). 1.6 Imaging methods require that images of the relevant FOV be captured at sufficient resolution to enable detection and characterization of individual cells and over a FOV that is sufficient to detect, discriminate between, and characterize colonies as complete objects for assessment. 1.7 Image processing procedures applicable to twoand three-dimensional data sets are used to identify cells or colonies as discreet objects within the FOV. Imaging methods may be optimized for multiple cell types and cell features using analytical tools for segmentation and clustering to define groups of cells related to each other by proximity or morphology in a manner that is indicative of a shared lineage relationship (that is, clonal expansion of a single founding stem cell or progenitor). 1.8 The characteristics of individual colony objects (cells per colony, cell density, cell size, cell distribution, cell heterogeneity, cell genotype or phenotype, and the pattern, distribution and intensity of expression of secondary markers) are informative of differences in underlying biological properties of the clonal progeny. 1.9 Under appropriately controlled experimental conditions, differences between colonies can be informative of the biological properties and underlying heterogeneity of colony founding cells (CFUs) within a starting population. 1.10 Cell and colony area/volume, number, and so forth may be expressed as a function of cell culture area (square millimeters), or initial cell suspension volume (milliliters). 1.11 Sequential imaging of the FOV using two or more optical methods may be valuable in accumulating quantitative information regarding individual cells or colony objects in the sample. In addition, repeated imaging of the same sample will be necessary in the setting of process tracking and validation. Therefore, this practice requires a means of reproducible identification of the location of cells and colonies (centroids) within the FOV area/volume using a defined coordinate system. 1.12 To achieve a sufficiently large field-of-view (FOV), images of sufficient resolution may be captured as multiple image fields/tiles at high magnification and then combined together to form a mosaic representing the entire cell culture area. 1.13 Cells and tissues commonly used in tissue engineering, regenerative medicine, and cellular therapy are routinely assayed and analyzed to define the number, prevalence, biological features, and biological potential of the original stem cell and progenitor population(s). 1.13.1 Common applicable cell types and cell sources include, but are not limited to: mammalian stem and progenitor cells; adult-derived cells (for example, blood, bone marrow, skin, fat, muscle, mucosa) cells, fetal-derived cells (for 1 This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.43 on Cells and Tissue Engineered Constructs for TEMPs. Current edition approved April 1, 2020. Published June 2020. Originally approved in 2012. Last previous edition approved in 2012 as F2944–12. DOI: 10.1520/F2944–20. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. example, cord blood, placental/cord, amniotic fluid); embryonic stem cells (ESC) (that is, derived from inner cell mass of blastocysts); induced pluripotent cells (iPC) (for example, reprogrammed adult cells); culture expanded cells; and terminally differentiated cells of a specific type of tissue. 1.13.2 Common applicable examples of mature differentiated phenotypes which are relevant to detection of differentiation within and among clonal colonies include: hematopoietic phenotypes (erythrocytes, lymphocytes, neutrophiles, eosinophiles, basophiles, monocytes, macrophages, and so forth), adult tissue-specific progenitor cell phenotypes (oteoblasts, chondrocytes, adipocytes, and so forth), and other tissues (hepatocytes, neurons, endothelial cells, keratinocyte, pancreatic islets, and so forth). 1.14 The number of stem cells and progenitor cells in various tissues can be assayed in vitro by liberating the cells from the tissues using methods that preserve the viability and biological potential of the underlying stem cell and/or progenitor population, and placing the tissue-derived cells in an in vitro environment that results in efficient activation and proliferation of stem and progenitor cells as clonal colonies. The true number of stem cells and progenitors (true colony forming units (tCFU)) can thereby be estimated on the basis of the number of colony-forming units observed (observed colony forming units (oCFU)) to have formed (1-3)2 (Fig. A1.1). The prevalence of stem cells and/or progenitors can be estimated on the basis of the number of observed colony-forming units (oCFU) detected, divided by the number of total cells assayed. 1.15 The automated image acquisition and analysis approach (described herein) to cell and colony enumeration has been validated and found to provide superior accuracy and precision when compared to the current “gold standard” of manual observer defined visual cell and colony counting under a brightfield or fluorescent microscope with or without a hemocytometer (4), reducing both intraand inter-observer variation. Several groups have attempted to automate this and/or similar processes in the past (5, 6). Recent reports further demonstrate the capability of extracting qualitative and quantitative data for colonies of various cell types at the cellular and even nuclear level (4, 7). 1.16 Advances in software and hardware now broadly enable systematic automated analytical approaches. This evolving technology creates the need for general agreement on units of measurement, nomenclature, process definitions, and analytical interpretation as presented in this practice. 1.17 Standardized methods for automated CFU analysis open opportunities to enhance the value and utility of CFU assays in several scientific and commercial domains: 1.17.1 Standardized methods for automated CFU analysis open opportunities to advance the specificity of CFU analysis methods though optimization of generalizable protocols and quantitative metrics for specific cell types and CFU assay systems which can be applied uniformly between disparate laboratories. 1.17.2 Standardized methods for automated CFU analysis open opportunities to reduce the cost of colony analysis in all aspects of biological sciences by increasing throughput and reducing work flow demands. 1.17.3 Standardized methods for automated CFU analysis open opportunities to improve the sensitivity and specificity of experimental systems seeking to detect the effects of in vitro conditions, biological stimuli, biomaterials and in vitro processing steps on the attachment, migration, proliferation, differentiation, and survival of stem cells and progenitors. 1.18 Limitations are described as follows: 1.18.1 Colony Identification—Cell Source/Colony Type/ Marker Variability—Stem cells and progenitors from various tissue sources and in different in vitro environments will manifest different biological features. Therefore, the specific means to detect cells or nuclei and secondary markers utilized and the implementation of their respective staining protocols will differ depending on the CFU assay system, cell type(s) and markers being interrogated. Optimized protocols for image capture and image analysis to detect cells and colonies, to define colony objects and to characterize colony objects will vary depending on the cell source being utilized and CFU system being used. These protocols will require independent optimization, characterization and validation in each application. However, once defined, these can be generalized between labs and across clinical and research domains. 1.18.2 Instrumentation-Induced Variability in Image Capture—Choice of image acquisition components described above may adversely affect segmentation of cells and subsequent colony identification if not properly addressed. For example, use of a mercury bulb rather than a fiber-optic fluorescent light source or the general misalignment of optics could produce uneven illumination or vignetting of tiled images comprising the primary large FOV image. This may be corrected by applying background subtraction routines to each tile in a large FOV image prior to tile stitching. 1.18.3 CFU Assay System Associated Variation in Imaging Artifacts—In addition to the presentation of colony objects with unique features that must be utilized to define colony identification, each image from each CFU system may present non-cell and non-colony artifacts (for example, cell debris, lint, glass aberrations, reflections, autofluorescence, and so forth) that may confound the detection of cells and colonies if not identified and managed. 1.18.4 Image Capture Methods and Quality Control Variation—Variation in image quality will significantly affect the precision and reproducibility of image analysis methods. Variation in focus, illumination, tile registration, exposure time, quenching, and emission spectral bleeding, are all important potential limitations or threats to image quality and reproducibility. 2 The boldface numbers in parentheses refer to a list of references at the end of this standard. F2944 − 20 2 1.19 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.20 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. 1.21 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.

Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture

KS J 0011-2019 生物技术指南噬菌体M13和它的DNA鉴定

Biotechnology ― Guide for identification of bacteriophage M13 and its DNA

ASTM E3226-19 从环境表面取样的炭疽芽孢杆菌

1.1 This test method covers a standardized method of processing cellulose wipes in a biosafety level 3 (BSL3) laboratory in order to detect and provide a semi-quantitative estimate of Bacillus anthracis contamination after sampling of non-porous surfaces. Sampling may be conducted to characterize the extent of the contamination, or for area clearance after decontamination. 1.2 The laboratory procedures should be performed in a BSL3 laboratory by those trained for BSL3 microbiological techniques. 1.3 This test method is specific to B. anthracis, but could be adapted for use with other organisms. 1.4 The interlaboratory study was conducted with cellulose sponge wipes pre-moistened with neutralizing buffer. All reproducibility, sensitivity, and specificity data are based on the performance of these wipes. A review was conducted by subcommittee in 2019, and re-confirmed these ILS data are valid. 1.5 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Processing Cellulose Sponge-wipes to Detect Bacillus anthracis Spores Sampled from Environmental Surfaces

DB61/T 1262-2019 反刍动物全混合日粮中碳水化合物平衡指数（CBI）的测定

Determination of Carbohydrate Balance Index (CBI) in Total Mixed Diets for Ruminants

ASTM D5245-19 微生物分析用实验室玻璃器皿 塑料器皿和设备的清洁

1.1 In microbiology, clean glassware is crucial to ensure valid results. Previously used or new glassware must be thoroughly cleaned. Laboratory ware and equipment that are not chemically clean are responsible for considerable losses in personnel time and supplies in many laboratories. These losses may occur as down time when experiments clearly have been adversely affected and as invalid data that are often attributed to experimental error. Chemical contaminants that adversely affect experimental results are not always easily detected. This practice describes the procedures for producing chemically clean glassware. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For specific precautions, see Section 6, 5.7.3.1, and 8.3.1. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Cleaning Laboratory Glassware, Plasticware, and Equipment Used in Microbiological Analyses

ASTM E2888-12(2019) 用pH值灭活啮齿动物逆转录病毒的过程的标准实施规程

1.1 This practice assures 5 log10 inactivation of nondefective C-type retroviruses, which are endogenous to murine hybridoma and CHO cells and are potentially present in the production stream of biopharmaceutical processes that use rodent derived cell culture. 1.2 The process parameters specified in this practice consistently assure 5 log10 inactivation of murine retrovirus by adjusting the pH of a process solution after initial affinity capture chromatography purification. 1.3 This practice is applicable to mAb, IgG fusion, or other recombinant proteins produced from rodent cell lines (for example, CHO or murine hybridoma), which do not target retroviral proteins. Additionally, the low pH step is performed on a cell-free intermediate, post initial capture using protein A chromatography. 1.4 The 5 log10 inactivation of murine retrovirus claimed by using this practice will be utilized in conjunction with other clearance unit operations (for example, chromatography and virus retentive filtration) to assure sufficient total process clearance of murine retroviruses, which will be supportive of early phase regulatory filings. 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 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.

Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

ASTM F3294-18 用宽场荧光显微镜在细胞分析中进行定量荧光强度测量的标准指南

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.

Standard Guide for Performing Quantitative Fluorescence Intensity Measurements in Cell-based Assays with Widefield Epifluorescence Microscopy

ASTM E3179-18 用模拟土壤测定织物载体上紫外线杀菌照射抗流感病毒抗菌效果的标准试验方法

1.1 This test method defines test conditions to evaluate ultraviolet germicidal irradiation (UVGI) light devices (mercury vapor bulbs, light-emitting diodes, or xenon arc lamps) that are designed to kill/inactivate influenza virus deposited on inanimate carriers. 1.2 This test method defines the terminology and methodology associated with the ultraviolet (UV) spectrum and evaluating UVGI dose. 1.3 This test method defines the testing considerations that can reduce UVGI surface kill effectiveness (that is, soiling). 1.4 Protocols for adjusting the UVGI dose to impact the reductions in levels of viable influenza virus are provided (Annex A1). 1.5 This test method does not address shadowing. 1.6 The test method should only be used by those trained in microbiology and in accordance with the guidance provided by Biosafety in Microbiological and Biomedical Laboratories.2 1.7 This test method is specific to influenza viruses 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.9 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location. 1.10 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. 1.11 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.

Standard Test Method for Determining Antimicrobial Efficacy of Ultraviolet Germicidal Irradiation against Influenza Virus on Fabric Carriers with Simulated Soil

ASTM E3180-18 用菌落生物膜模型生长的由营养细胞和孢子组成的枯草芽孢杆菌生物膜定量的标准试验方法

1.1 This test method specifies the operational parameters required to grow and quantify a Bacillus subtilis biofilm comprised of vegetative cells and endospores (spores) using the colony biofilm method (CBM).2,3 The resulting biofilm is representative of static environments that can develop a sporulating biofilm rather than being representative of one particular environment. 1.2 This test method utilizes a modified CBM to grow the biofilm. The CBM uses a semipermeable membrane on an agar plate as the biofilm growth surface and nutrient source.2,3 In this test method, membranes are inoculated and incubated for a total of 8 days to promote sporulation within the biofilm. 1.3 This test method describes how to sample and analyze the biofilm for vegetative cells and spores. Biofilm population is expressed as total colony forming units (CFU) and spores per membrane. 1.4 Basic microbiology training is required to perform this test method. 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.

Standard Test Method for Quantification of a Bacillus subtilis Biofilm Comprised of Vegetative Cells and Spores Grown Using the Colony Biofilm Model

NY/T 3293-2018 黄曲霉生防菌活性鉴定技术规程

Technical regulations for identification of the activity of Aspergillus aflatoxin biocontrol bacteria

ASTM E2180-18 用于测定聚合物或疏水材料中加入的抗微生物剂活性的标准测试方法

1.1 This test method is designed to evaluate (quantitatively) the antimicrobial effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces. The method focuses primarily on assessing antibacterial activity; however, other microorganisms such as yeast and fungal conidia may be tested using this method. 1.2 The vehicle for the inoculum is an agar slurry which reduces the surface tension of the saline inoculum carrier and allows formation of a “pseudo-biofilm,” providing more even contact of the inoculum with the test surface. NOTE 1—This test method facilitates the testing of hydrophobic surfaces by utilizing cells held in an agar slurry matrix. This test method, as written, is inappropriate to determine efficacy against biofilm cells, which are different both genetically and metabolically than planktonic cells used in this test. 1.3 This method can confirm the presence of antimicrobial activity in plastics or hydrophobic surfaces and allows determination of quantitative differences in antimicrobial activity between untreated plastics or polymers and those with bound or incorporated low water-soluble antimicrobial agents. Comparisons between the numbers of survivors on preservativetreated and control hydrophobic surfaces may also be made. 1.4 The procedure also permits determination of “shelf-life” or long term durability of an antimicrobial treatment which may be achieved through testing both non-washed and washed samples over a time span. 1.5 Knowledge of microbiological techniques is required for these procedures. 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. 1 This test method is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents. Current edition approved May 1, 2018. Published May 2018. Originally approved in 2001. Last previous edition approved in 2018 as E2180 – 07(2017). DOI: 10.1520/E2180-18. 2 Price, D. L., Sawant, A. D., and Ahearn, D. G., “Assessment of the antimicrobial activity of an insoluble quaternary amine complex in plastics,” J. Industr. Microbiol, Vol 8, No. 2, 1991, pp. 83–89. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 2. Referenced Documents

Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials

ASTM E3135-18 用模拟土壤测定载体上微生物紫外线杀菌辐射抗菌效果的标准实施规程

1.1 This practice will define test conditions to evaluate ultraviolet germicidal irradiation (UVGI) light devices (mercury vapor bulbs, light-emitting diodes, or xenon arc lamps) that are designed to kill/inactivate microorganisms deposited on inanimate carriers. 1.2 This practice defines the terminology and methodology associated with the ultraviolet (UV) spectrum and evaluating UVGI dose. 1.3 This practice defines the testing considerations that can reduce UVGI surface kill effectiveness, that is, presence of a soiling agent. 1.4 This practice does not address shadowing. 1.5 This practice should only be used by those trained in microbiology and in accordance with the guidance provided by Biosafety in Microbiological and Biomedical Laboratories (5th edition), 2009, HHS Publication No. (CDC) 21-1112. 1.6 This practice does not recommend either specific test microbes or growth media. Users of this practice shall select appropriate test microbes and growth media based on the specific objectives of their UV antimicrobial performance evaluation test plan. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercurycontaining products. See the applicable product Safety Data Sheet (SDS) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, may be prohibited by local or national law. 1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Determining Antimicrobial Efficacy of Ultraviolet Germicidal Irradiation Against Microorganisms on Carriers with Simulated Soil

ASTM E3161-18 使用CDC生物膜反应器制备绿脓杆菌或金黄色葡萄球菌生物膜的标准实施规程

Standard Practice for Preparing a Pseudomonas aeruginosa or Staphylococcus aureus Biofilm using the CDC Biofilm Reactor

T/SZGIA 1.2-2018 基于高通量测序的环境微生物检测 第2部分：人粪便微生物宏基因组检测方法

本部分规定了采用高通量测序技术进行人粪便微生物宏基因组检测的方法。

Detection of environmental microorganisms based on high-throughput sequencing Part 2: Methodology of detecting human fecal microbiota using metagenomic sequencing

ASTM D6831-11(2018) 使用堆叠式 惯性微量天平采样和确定堆积气体中的颗粒物的标准测试方法

1.1 This test method describes the procedures for determining the mass concentration of particulate matter in gaseous streams using an automated, in-stack test method. This test method, an in-situ, inertial microbalance, is based on inertial mass measurement using a hollow tube oscillator. This test method is describes the design of the apparatus, operating procedure, and the quality control procedures required to obtain the levels of precision and accuracy stated. 1.2 This test method is suitable for collecting and measuring filterable particulate matter concentrations in the ranges 0.2 mg/m3 and above taken in effluent ducts and stacks. 1.3 This test method may be used for calibration of automated monitoring systems (AMS). If the emission gas contains unstable, reactive, or semi-volatile substances, the measurement will depend on the filtration temperature, and this test method (and other in-stack methods) may be more applicable than out-stack methods for the calibration of automated monitoring systems. 1.4 This test method can be employed in sources having gas temperature up to 200°C (392°F) and having gas velocities from 3 to 27 m/s. 1.5 This test method includes a description of equipment and methods to be used for obtaining and analyzing samples and a description of the procedure used for calculating the results. 1.6 This test method may also be limited from use in sampling gas streams that contain fluoride, or other reactive species having the potential to react with or within the sample train. 1.7 Appendix X1 provides procedures for assessment of the spatial variation in particulate matter (PM) concentration within the cross section of a stack or duct test location to determine whether a particular sampling point or limited number of sampling points can be used to acquire representative PM samples. 1.8 Appendix X2 provides procedures for reducing the sampling time required to perform calibrations of automated monitoring systems where representative PM samples can be acquired from a single sample point and certain other conditions are met. 1.9 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard. 1.10 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. 1.11 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.

Standard Test Method for Sampling and Determining Particulate Matter in Stack Gases Using an In-Stack, Inertial Microbalance

ASTM E2197-17e1 用于测定化学品的杀菌 杀病毒 杀真菌 分枝杆菌和杀芽孢活性的标准定量盘载体测试方法

1.1 This test method is designed to evaluate the ability of test substances to inactivate vegetative bacteria, viruses, fungi, mycobacteria, and bacterial spores (1-7) on disk carriers of brushed stainless steel that represent hard, nonporous environmental surfaces and medical devices. It is also designed to have survivors that can be compared to the mean of no less than three control carriers to determine if the performance standard has been met. For proper statistical evaluation of the results, the number of viable organisms in the test inoculum should be sufficiently high to take into account both the performance standard and the experimental variations in the results. 1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing wipes. 1.3 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (8). 1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions). 1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and metric units follow. 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.

Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals

ASTM D7847-17 微生物测试方法实验室研究标准指南

1.1 Microbiological test methods present challenges that are unique relative to chemical or physical parameters, because microbes proliferate, die off and continue to be metabolically active in samples after those samples have been drawn from their source. 1.1.1 Microbial activity depends on the presence of available water. Consequently, the detection and quantification of microbial contamination in fuels and lubricants is made more complicated by the general absence of available water from these fluids. 1.1.2 Detectability depends on the physiological state and taxonomic profile of microbes in samples. These two parameters are affected by various factors that are discussed in this guide, and contribute to microbial data variability. 1.2 This guide addresses the unique considerations that must be accounted for in the design and execution of interlaboratory studies intended to determine the precision of microbiological test methods designed to quantify microbial contamination in fuels, lubricants and similar low watercontent (water activity

Standard Guide for Interlaboratory Studies for Microbiological Test Methods

ASTM E2180-07(2017) 用于测定聚合物或疏水材料中加入的抗微生物剂活性的标准测试方法

1.1 This test method is designed to evaluate (quantitatively) the antimicrobial effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces. The method focuses primarily on assessing antibacterial activity; however, other microorganisms such as yeast and fungal conidia may be tested using this method. 1.2 The vehicle for the inoculum is an agar slurry which reduces the surface tension of the saline inoculum carrier and allows formation of a “pseudo-biofilm,” providing more even contact of the inoculum with the test surface. NOTE 1—This test method facilitates the testing of hydrophobic surfaces by utilizing cells held in an agar slurry matrix. This test method, as written, is inappropriate to determine efficacy against biofilm cells, which are different both genetically and metabolically than planktonic cells used in this test. 1.3 This method can confirm the presence of antimicrobial activity in plastics or hydrophobic surfaces and allows determination of quantitative differences in antimicrobial activity between untreated plastics or polymers and those with bound or incorporated low water-soluble antimicrobial agents. Comparisons between the numbers of survivors on preservativetreated and control hydrophobic surfaces may also be made. 1.4 The procedure also permits determination of “shelf-life” or long term durability of an antimicrobial treatment which may be achieved through testing both non-washed and washed samples over a time span. 1.5 Knowledge of microbiological techniques is required for these procedures. 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 and health 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. 1 This test method is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents. Current edition approved April 1, 2017. Published April 2017. Originally approved in 2001. Last previous edition approved in 2012 as E2180 – 07(2012). DOI: 10.1520/E2180-07R17. 2 Price, D. L., Sawant, A. D., and Ahearn, D. G., “Assessment of the antimicrobial activity of an insoluble quaternary amine complex in plastics,” J. Industr. Microbiol, Vol 8, No. 2, 1991, pp. 83–89. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States 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. 1 2. Referenced Documents

Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials

ASTM E2799-17 使用MBEC测定法测定铜绿假单胞菌生物膜消毒功效的标准测试方法

1.1 This test method specifies the operational parameters required to grow and treat a Pseudomonas aeruginosa biofilm in a high throughput screening assay known as the MBEC (trademarked)2 (Minimum Biofilm Eradication Concentration) Physiology and Genetics Assay. The assay device consists of a plastic lid with ninety-six (96) pegs and a corresponding receiver plate with ninety-six (96) individual wells that have a maximum 200 µL working volume. Biofilm is established on the pegs under batch conditions (that is, no flow of nutrients into or out of an individual well) with gentle mixing. The established biofilm is transferred to a new receiver plate for disinfectant efficacy testing.3,4 The reactor design allows for the simultaneous testing of multiple disinfectants or one disinfectant with multiple concentrations, and replicate samples, making the assay an efficient screening tool. 1.2 This test method defines the specific operational parameters necessary for growing a Pseudomonas aeruginosa biofilm, although the device is versatile and has been used for growing, evaluating and/or studying biofilms of different species as seen in Refs (1-4).5 1.3 Validation of disinfectant neutralization is included as part of the assay. 1.4 This test method describes how to sample the biofilm and quantify viable cells. Biofilm population density is recorded as log10 colony forming units per surface area. Efficacy is reported as the log10 reduction of viable cells. 1.5 Basic microbiology training is required to perform this assay. 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 ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility. 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 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.

Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay

ASTM E2562-17 使用CDC生物膜反应器在高剪切和连续流动条件下生长的绿脓杆菌生物膜定量的标准试验方法

1.1 This test method specifies the operational parameters required to grow a reproducible (1)2 Pseudomonas aeruginosa ATCC 700888 biofilm under high shear. The resulting biofilm is representative of generalized situations where biofilm exists under high shear rather than being representative of one particular environment. 1.2 This test method uses the Centers for Disease Control and Prevention (CDC) Biofilm Reactor. The CDC Biofilm Reactor is a continuously stirred tank reactor (CSTR) with high wall shear. Although it was originally designed to model a potable water system for the evaluation of Legionella pneumophila (2), the reactor is versatile and may also be used for growing and/or characterizing biofilm of varying species (3-5). 1.3 This test method describes how to sample and analyze biofilm for viable cells. Biofilm population density is recorded as log10 colony forming units per surface area. 1.4 Basic microbiology training is required to perform this test method. 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 and health 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.

Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor