07.100.10 (Medical microbiology) 标准查询与下载

ASTM E1536-00 用大容量试验法探测牛血清支原体污染物的标准实施规程

1.1 This practice covers the procedures used for detection of mycoplasma contamination in serum by direct microbiological culture.1.2 This practice does not cover procedures used for detection of mycoplasma in cell cultures.1.3 This practice does not cover indirect methods for detection of mycoplasma contamination.1.4 This practice does not cover methods for identification of mycoplasma cultures.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by the Large Volume Method

ASTM E1968-98 法医检定法中微晶体试验的标准指南

1.1 This guide describes some standard procedures applicable to the analysis of cocaine using multiple microcrystal tests. 1.2 These procedures are applicable to cocaine, which is present in solid dosage form or an injectable liquid form.. They are not typically applicable to the analysis of cocaine in biological samples.

Standard Guide for Microcrystal Testing in the Forensic Analysis of Cocaine

ASTM E1968-98(2003) 法医检定法中微晶体试验的标准指南

This technique produces a chemical-precipitation reaction between cocaine and the precipitating reagent. The habit and the aggregation of the crystals formed may be used to distinguish cocaine from other drugs. This technique can be utilized on cocaine present in either the salt or free base form. This technique does not distinguish between the salt and free base forms.1.1 This guide describes some standard procedures applicable to the analysis of cocaine using multiple microcrystal tests.1.2 These procedures are applicable to cocaine, which is present in solid dosage form or an injectable liquid form. They are not typically applicable to the analysis of cocaine in biological samples.

Standard Guide for Microcrystal Testing in the Forensic Analysis of Cocaine

ASTM E1326-98 细菌计数用的非常规微生物试验的评价

1.1 The purpose of this guide is to assist users and producers of nonconventional tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Conventional procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time and degree of accuracy. It is these limitations that have recently led to the marketing of a variety of non-conventional procedures, test kits and instruments. 1.2 A conventional test is one that is widely accepted and published as a standard microbiological method or related procedure. A new, nonconventional test method will attempt to provide the same information through the measurement of a different parameter. This guide is designed for comparing levels of bacteria recovered from samples by the Heterotrophic Plate Count Procedure to the equivalent units determined with a nonconventional test. 1.3 It is recognized that the Heterotrophic Plate Count does not recover all microorganisms present in a product or a system (1). When this problem occurs during the characterization of a microbiological population, alternate standard enumeration procedures may be necessary, as in the case of sulfate-reducing bacteria. At other times, chemical methods that measure the rates of appearance of metabolic derivatives or the utilization of contaminated product components might be indicated. In evaluating nonconventional tests, the use of these alternate standard procedures may be the only means available for establishing correlation. In such cases, this guide can serve as a reference for those considerations. 1.4 Since there are so many types of tests that could be considered nonconventional, it is impossible to recommend a specific test protocol with statistical analyses for evaluating the tests. Instead, this guide should assist in determining what types of tests should be considered to verify the utility and identify the limitations of the nonconventional test.

Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria

ASTM E1280-97(2003) 哺乳动物细胞诱变性用老鼠淋巴瘤鉴定实施

This guide is limited to procedures used solely for the testing of substances to determine their mutagenicity and does not apply to other methods and uses such as exploring mechanisms of mutation. Recent evidence suggests that this assay measures a dual genetic end point; therefore, some discussion of the relationships between mammalian cell mutagenicity testing results and the results observed both in pure gene mutational assays and in cytogenetic assays is necessary. However, it is not the intent of this guide to discuss other relationships between this mammalian cell mutagenicity testing results and the results observed in other tests for mutagenicity and carcinogenicity.1.1 The purpose and scope of this guide is to present background material and to establish criteria by which protocols and procedures for conducting the L5178Y/TK+/-3.7.2C mouse lymphoma mutagenicity assay (commonly referred to as the mouse lymphoma assay, (MLA)) can be properly understood and evaluated. This guide is also intended to aid researchers and others to gain a better understanding of the critical elements involved with mammalian cell mutagenicity testing. More specifically, this guide is intended to provide for researchers the accomplishment of the following goals:1.1.1 Provide an understanding of the critical procedures (steps) in the performance of this mammalian cell mutagenicity test.1.1.2 Provide generalized criteria by which researchers can evaluate if they are properly performing, utilizing, and interpreting this assay.1.1.3 Provide criteria by which individuals responsible for evaluating MLA data can determine if the experiments have been properly performed and interpreted.1.1.4 Provide a basis from which new procedures and developments in testing procedures can be evaluated.1.1.5 Provide an understanding of the types of genetic damage (that is, gene and chromosome mutation) that may be detected in this mammalian cell mutagenicity test.

Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity

ASTM E1881-97(2002) SIMS细胞培养分析的标准指南

1.1 This guide provides the Secondary Ion Mass Spectrometry (SIMS) analyst with a cryogenic method for analyzing individual tissue culture cells growing in vitro. This guide is suitable for frozen-hydrated and frozen-freeze-dried sample types. Included are procedures for correlating optical, laser scanning confocal and secondary electron microscopies to compliment SIMS analysis.1.2 This guide is not suitable for cell cultures that do not attach to the substrate.1.3 This guide is not suitable for any plastic embedded cell culture specimens.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Guide for Cell Culture Analysis with SIMS

ASTM E1280-97 哺乳动物细胞诱变性用老鼠淋巴瘤鉴定实施

1.1 The purpose and scope of this guide is to present background material and to establish criteria by which protocols and procedures for conducting the L5178Y/TK +/- 3.7.2C mouse lymphoma mutagenicity assay (commonly referred to as the mouse lymphoma assay, (MLA)) can be properly understood and evaluated. These guidelines are also intended to aid researchers and others to gain a better understanding of the critical elements involved with mammalian cell mutagenicity testing. More specifically, this guide is intended to provide for researchers the accomplishment of the following goals: 1.1.1 Provide an understanding of the critical procedures (steps) in the performance of this mammalian cell mutagenicity test. 1.1.2 Provide generalized criteria by which researchers can evaluate if they are properly performing, utilizing, and interpreting this assay. 1.1.3 Provide criteria by which individuals responsible for evaluating MLA data can determine if the experiments have been properly performed and interpreted. 1.1.4 Provide a basis from which new procedures and developments in testing procedures can be evaluated. 1.1.5 Provide an understanding of the types of genetic damage (that is, gene and chromosomal mutation) that may be detected in this mammalian cell mutagenicity test.

Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity

ASTM E1847-96(2008) 根据ASTM指南进行毒素试验统计分析的标准实施规程

1.1 This practice covers guidance for the statistical analysis of laboratory data on the toxicity of chemicals or mixtures of chemicals to aquatic or terrestrial plants and animals. This practice applies only to the analysis of the data, after the test has been completed. All design concerns, such as the statement of the null hypothesis and its alternative, the choice of alpha and beta risks, the identification of experimental units, possible pseudo replication, randomization techniques, and the execution of the test are beyond the scope of this practice. This practice is not a textbook, nor does it replace consultation with a statistician. It assumes that the investigator recognizes the structure of his experimental design, has identified the experimental units that were used, and understands how the test was conducted. Given this information, the proper statistical analyses can be determined for the data.1.1.1 Recognizing that statistics is a profession in which research continues in order to improve methods for performing the analysis of scientific data, the use of statistical methods other than those described in this practice is acceptable as long as they are properly documented and scientifically defensible. Additional annexes may be developed in the future to reflect comments and needs identified by users, such as more detailed discussion of probit and logistic regression models, or statistical methods for dose response and risk assessment.1.2 The sections of this guide appear as follows:TitleSectionReferenced DocumentsTerminologySignificance and UseStatistical MethodsFlow ChartFlow Chart CommentsKeywords ReferencesThis 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 Practice for Statistical Analysis of Toxicity Tests Conducted Under ASTM Guidelines

ASTM E1535-93(1998) 厌氧消化系统性能估计的标准试验方法

1.1 This test method is applicable to all anaerobic digestion systems. 1.2 This standard does not purport to address all of the safety problems, 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 Performance Evaluation of Anaerobic Digestion Systems

ASTM E1533-93 4-6-二醚基-2-2-苯胺基(DAPI)染色法间接检测细胞培养中菌质的标准实施规程

1.1 This practice covers procedures used for the detection of mycoplasma contamination by indirect DNA staining. 1.2 This practice does not cover direct methods for the detection of mycoplasma or other indirect methods such as enzymatical detection or DNA probes. 1.3 This practice does not cover methods for the identification of mycoplasma organisms. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.5 This standard does not purport to address all of the safety problems, 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 Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining

ASTM E1285-89(2000) 噬菌体λ(拉姆达)或它的脱氧核糖核酸的识别标准指南

1.1 This guide covers the procedures for identifying bacteriophage lambda used in biotechnology. 1.2 There are hundreds of lambda variants that can be used for biotechnology. These lambda variants are derived from wild type lambda and differ in genome size and genotype. 1.3 If the bacteriophage lambda is to be used to construct a recombinant molecule, then the same criteria as prescribed in Section 5 should be used to characterize the newly made DNA.

Standard Guide for Identification of Bacteriophage Lambda ([lambda]) or Its DNA

ASTM F895-84(2001)e1 琼脂扩散细胞培养屏蔽细胞毒素的试验方法

1.1 This test method is appropriate for materials in a variety of shapes and for materials which are not necessarily sterile. This test method would be appropriate in situations where the amount of material is limited. For example, small devices or powders could be placed on the agar and the presence of a zone of inhibition of cell growth could be examined. 1.1.1 This test method is not appropriate for leachables which do not diffuse through agar or agarose. 1.1.2 While the agar layer can act as a cushion to protect the cells from the specimen, there may be materials which are sufficiently heavy to compress the agar and prevent diffusion or to cause mechanical damage to the cells. This test method would not be appropriate for these materials. 1.2 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred, only that the L-929 is an established cell line, well-characterized and readily available, that has demonstrated reproducible results in several laboratories. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

ASTM F895-84(2006) 琼脂扩散细胞培养屏蔽细胞毒素的试验方法

This test method is useful for assessing the cytotoxic potential of new materials and formulations and as part of a quality control program for established medical devices and components. This test method assumes that assessment of cytotoxicity provides useful information to aid in predicting the potential clinical applications in humans. Cell culture methods have shown good correlation with animal assays and are frequently more sensitive to cytotoxic agents. This cell culture test method is suitable for incorporation into specifications and standards for materials to be used in the construction of medical devices that are to be implanted into the human body or placed in contact with tissue fluids or blood on a long-term basis. Some biomaterials with a history of safe clinical use in medical devices are cytotoxic. This test method does not imply that all biomaterials must pass this assay to be considered safe for clinical use (Practice F 748).1.1 This test method is appropriate for materials in a variety of shapes and for materials which are not necessarily sterile. This test method would be appropriate in situations where the amount of material is limited. For example, small devices or powders could be placed on the agar and the presence of a zone of inhibition of cell growth could be examined. 1.1.1 This test method is not appropriate for leachables which do not diffuse through agar or agarose. 1.1.2 While the agar layer can act as a cushion to protect the cells from the specimen, there may be materials which are sufficiently heavy to compress the agar and prevent diffusion or to cause mechanical damage to the cells. This test method would not be appropriate for these materials. 1.2 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred, only that the L-929 is an established cell line, well-characterized and readily available, that has demonstrated reproducible results in several laboratories. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

ASTM D4198-82(2003) 细菌分析和生长用的和膜过滤器一起使用的吸收性垫片的评价方法

These test methods are appropriate for qualifying absorbent pads used with membrane filters for bacteriological enumeration. 5.1.1 The test methods described are applicable to quality control testing of absorbent pads by the suppliers and users of these pads and to specification testing of absorbent pads intended for use with membrane filters in bacteriological enumeration. Other pure culture organisms and their appropriate culture medium may be substituted for the E. coli and M-FC media for specification testing, as required.1.1 These test methods cover the determination of the nutrient-holding capacity and the toxic or nutritive effect on bacterial growth of organisms retained on a membrane filter, when the absorbent pad being tested is used as a nutrient reservoir and medium supply source for the retained bacteria. 1.2 The tests described are conducted on 47-mm diameter disks, although other size disks may be employed for bacterial culture techniques. 1.3 This standard does not purport to address all of the safety problems, 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 Methods for Evaluating Absorbent Pads Used with Membrane Filters for Bacteriological Analysis and Growth

ASTM D4198-82(1998) 评估用于细菌分析和生长的膜过滤器的吸收垫的标准测试方法

1.1 These test methods cover the determination of the nutrient-holding capacity and the toxic or nutritive effect on bacterial growth of organisms retained on a membrane filter, when the absorbent pad being tested is used as a nutrient reservoir and medium supply source for the retained bacteria. 1.2 The tests described are conducted on 47-mm diameter disks, although other size disks may be employed for bacterial culture techniques. 1.3 This standard does not purport to address all of the safety problems, 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 Methods for Evaluating Absorbent Pads Used with Membrane Filters for Bacteriological Analysis and Growth