07.100.01 微生物学综合 标准查询与下载

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

T/SZGIA 2-2016 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

本标准规定了检测对象、检测要求、样品采集、保存与运输的要求；检测步骤包括实验室必须要满足的条件；以及DNA的质量判定标准；文库构建以及高通量测序流程；数据信息分析和数据质量控制的要求。其中数据质量控制规定了质量要求和数量要求，质量要求测序完成后，每个DNA样品对应的有效可用数据质量值应符合如下要求：Q20≥90%，该样品测序结果90%以上的碱基质量值大于20；Q30≥80%，该样品测序结果80%以上的碱基质量值大于30。而数量要求：为了完成后续物种注释，功能分析等数据分析步骤，要求每个样品测序短序列数目（

Detection of environmental microorganisms based on high-throughput sequencing

GOST R 57682-2017 微生物产品 黄原胶技术 规格

Microbiological products. Xanthan technical. Specifications

ASTM E2197-17 测定液体化学杀菌剂的杀菌, 杀病毒, 杀真菌, 杀分枝杆菌和杀孢子活性的标准定量圆盘载体试验方法

5.1 The design of this test eliminates any loss of viable organisms through wash off, thus making it possible to produce statistically valid data using many fewer test carriers than needed for methods based on simple MPN estimates. 5.2 The stringency in the test is provided by the use of a soil load, the microtopography of the brushed stainless steel carrier surface, and the smaller ratio of test substance to surface area typical for many disinfectant applications. Thus, the test substance being assessed is presented with a reasonable challenge while allowing for efficient recovery of the test organisms from the inoculated carriers. The metal disks in the basic test are also compatible with a wide variety of actives. 5.3 The design of the carriers makes it possible to place onto each a precisely measured volume of the test organism (10 μL) as well as the control fluid or test substance (50 μL). 5.4 The inoculum is placed at the center of each disk whereas the volumes of the test substance covers nearly the entire disk surface, thus virtually eliminating the risk of any organisms remaining unexposed. 5.5 In all tests, other than those against viruses, the addition of 10 mL of an eluent/diluent gives a 1:200 dilution of the test substance immediately at the end of the contact time. While this step in itself may be sufficient to arrest the microbicidal activity of most actives, the test protocol permits the addition of a specific neutralizer to the eluent/diluent, if required. Except for viruses, the membrane filtration step also allows processing of the entire eluate from the test carriers and, therefore, the capture and subsequent detection of even low numbers of viable organisms that may be present. Subsequent rinsing of the membrane filters with saline also reduces the risk of carrying any inhibitory residues over to the recovery medium. Validation of the process of neutralization of the test substance is required by challenge with low numbers of the test organism. 5.6 In tests against viruses, addition of 1 mL of buffer at the end of the contact time achieves a 1:20 dilution of the test substance while keeping the volume of the eluate reasonably small to allow for the titration of most or all of the eluate in cell cultures. Confirmation of neutralization of the test substance is required by challenge of a residual disinfection load with low numbers of infective units of the test virus. Since the virus assay system is indirect, an additional step is required to demonstrate that prior exposure of the appropriate cell line to any residual disinfectant or disinfectant/neutralizer mixture does not interfere with the detection of a low level of virus challenge (See Appendix). Note 1: In 5.5 and 5.6, volumes of 10 mL and 1 mL are recommended instead of 9.95 mL and 950 μL, respectively, for ease of dispensing the eluent. 5.7 The soil load in this test is a mixture of three types of proteins (high molecular weight proteins, low molecular weight peptides, and mucous material)

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

T/SZGIA 1-2016 基于高通量测序的微生物检测方法 第1部分：基本规程

本标准规定了采用高通量测序技术进行环境微生物检测的方法，包括样本的采集、保存，实验室工 作条件，样本处理程序、质量控制及关键分析步骤。

High-throughput sequencing-based microbial detection methods Part 1: Basic procedures

GOST R 57233-2016 微生物产品. 验收规范和取样方法

Microbiological products. Acceptance regulations and methods of sampling

GOST R 57234-2016 微生物产品. 包装, 标记, 运输和存放

Microbiological products. Packing, marking, transportation and storage

ASTM F2149-16 自动细胞分析-枚举和获得单细胞悬液的电子感应区方法的标准试验方法

3.1 The electrical sensing zone method for cell counting is used in tissue culture, government research, and hospital, biomedical, and pharmaceutical laboratories for counting and sizing cells. The method may be applicable to a wide range of cells sizes and cell types, with appropriate validation (10). 3.2 The electrical sensing zone methodology was introduced in the mid-1950s (9). Since this time, there have been substantial improvements which have enhanced the operator's ease of use. Among these are the elimination of the mercury manometer, reduced size, greater automation, and availability of comprehensive statistical computer programs. 3.3 This instrumentation offers a rapid result as contrasted to the manual counting of cells using the hemocytometer standard counting chamber. The counting chamber is known to have an error of 10 to 308201;%, as well as being time-consuming (11). In addition, when counting and sizing porcine hepatocytes, Stegemann et al concluded that the automated, electrical sensing zone method provided greater accuracy, precision, and speed, for both counts and size, compared to the conventional microscopic or the cell mass-based method (7). 1.1 This test method, provided the limitations are understood, covers a procedure for both the enumeration and measurement of size distribution of most all cell types. The instrumentation allows for user-selectable cell size settings and is applicable to a wide range of cell types. The method works best for spherical cells, and may be less accurate if cells are not spherical, such as for discoid cells or budding yeast. The method is appropriate for suspension as well as adherent cell cultures (1).2 Results may be reported as number of cells per milliliter or total number of cells per volume of cell suspension analyzed. Size distribution may be expressed in cell diameter or volume. 1.2 Cells commonly used in tissue-engineered medical products (2) are analyzed routinely. Examples are chondrocytes (3), fibroblasts (4), and keratinocytes (5). Szabo et al. used the method for both pancreatic islet number and volume measurements (6). In addition, instrumentation using the electrical sensing zone technology was used for both count and size distribution analyses of porcine hepatocytes placed into hollow fiber cartridge extracorporeal liver assist systems. In this study

Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions

ASTM F1608-16 用于多孔包装材料的微生物排序的标准试验方法 (曝光室法)

5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following: 5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions. 5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package. 5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems). 5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions. 1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material. 1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3. 1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards. 1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC......

Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

DB65/T 3824-2015 有机物料腐熟剂使用技术规程

Technical regulations for the use of decomposing agents for organic materials

GOST R 55234.4-2014 风险管理的实践环节. 生物风险减少的人员要求

Practical aspects of management of risk. Requirements to the personnel for biorisk decrease

GOST R 55234.3-2013 风险管理的实践方面. 基于风险的检验和维护程序

Practical aspects of management of risk. Risk-Based Inspection and Maintenance Procedures

GOST R 55234.2-2013 风险管理的实践方面. 生物危害管理

Practical aspects of management of risk. Biorisk management

KS J ISO 7954-2012 微生物学 酵母菌和霉菌计数通用指南 25℃菌落计数技术

Microbiology－General guidance for enumeration of yeasts and moulds－Colony count technique at 25 ℃

KS J ISO 8914-2012 微生物学 副溶血弧菌检测通用指南

Microbiology－General guidance for the detection of Vibrio parahaemolyticus

DB46/T 219-2012 橡胶树小蠹虫防治技术规程

适用于海南省橡胶树小蠹虫防治。

Technical regulations on rubber tree bark beetle control

BS CWA 16393:2012 实验室生物安全管理.实施CWA 15793:2008标准的导则

Laboratory biorisk management. Guidelines for the implementation of CWA 15793:2008

DS/CWA 15793:2011 实验室生物风险管理

The scope of this laboratory biorisk management system agreement is to set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.This CWA will enable organizations to: a) establish and maintain a biorisk management system to control or minimize risk to acceptable levels in relation to employees, the community and others as well as the environment which could be directly or indirectly exposed to biological agents or toxins;b) provide assurance that the requirements are in place and implemented effectively;c) seek and achieve certification or verification of

Laboratory biorisk management

ASTM D6831-11 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

The measurement of particulate matter is widely performed to characterize emissions from stationary sources in terms of total emission rates to the atmosphere for regulatory purposes. This test method is particularly well suited for use in performance assessment and optimization of particulate matter control systems, continuous particulate matter emissions monitoring systems and the measurement of low concentration particulate matter laden gas streams in the range of 0.2 mg/m3 to 50 mg/m3.1.1 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 method, an in-situ, inertial microbalance, is based on inertial mass measurement using a hollow tube oscillator. This 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 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 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 200C 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 Stack temperatures limitation for this test method is approximately 200C (392F).1.7 This test method may be 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.1.8 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.

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

BS CWA 15793:2011 实验室生物危害管理

Laboratory biorisk management