07.100.10 (Medical microbiology) 标准查询与下载

ASTM E1326-15 细菌计数用的非常规微生物试验的评价

5.1 This guide should be used by producers and potential producers of non-culture tests to determine the accuracy, selectivity, specificity, and reproducibility of the tests, as defined in Practice E691. Results of such studies should identify the limitations and indicate the utility or applicability of the non-culture test, or both, for use on different types of samples. 5.2 Non-culture test users and potential users should employ this guide to evaluate results of the non-culture test as compared to their present methods. Practices D5245 and D5465 should be reviewed in regards to the microbiological methods employed. If culture methods have not been used for monitoring the systems, then guidelines are included for obtaining microbiological expertise. 5.3 Utilization of a non-culture test can reduce the time required to determine the microbiological status of the system and detect microbe that are not detected by culture testing. Consequently, non-culture tests can contribute to the improvement in the overall operating efficiency of microbial contamination condition monitoring and diagnostic efforts, and microbicide performance evaluations. 5.4 Detecting microbial contamination levels that exceed predetermined upper control limits indicates the need for an addition of an antimicrobial agent or other corrective maintenance action. By accurately determining this in a shorter time period than is possible than by culture methods, treatment with antimicrobial agents may circumvent more serious problems than if the treatment were postponed until culture results were available. If the antimicrobial treatment program relied on an inaccurate non-culture test, then unnecessary loss of product and problems associated with inappropriate selection or improper dosing with antimicrobial agents would exist. 5.5 Since many methods based on entirely different chemical and microbiological principles are considered, it is not possible to establish a unique design and recommend a specific method of statistical analyses for the comparisons to be made. It is only possible to present guides that should be followed while performing the experiments. It is also recommended that a statistician be involved in the study. 1.1 The purpose of this guide is to assist users and producers of non-culture tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time and degree of accuracy. Moreover any given culture test method typically recovers only a fraction of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments. 1.2 Culture test methods estimate microbial population densities based on the ability of mircoorganisms in a sample to proliferate in or on a specified growth medium, u......

Standard Guide for Evaluating Non-culture Microbiological Tests Used for Enumerating Bacteria

ASTM F2997-13 采用荧光图像分析量化祖细胞成骨培养钙沉积的标准实施规程

5.1 In-vitro osteoblast differentiation assays are one approach to screen progenitor stem cells for their capability to become osteoblasts. The extent of calcified deposits or mineralized matrix that form in-vitro may be an indicator of differentiation to a functional osteoblast; however, gene expression of osteogenic genes or proteins is another important measurement to use in conjunction with this assay to determine the presence of an osteoblast. 5.2 This test method provides a technique for staining, imaging, and quantifying the fluorescence intensity and area related to the mineralization in living cell cultures using the non-toxic calcium-chelating dye, xylenol orange. The positively stained area of mineralized deposits in cell cultures is an indirect measure of calcium content. It is important to measure the intensity to assure that the images have not been underexposed or overexposed. Intensity does not correlate directly to calcium content as well as area. 5.3 Xylenol orange enables the monitoring of calcified deposits repeatedly throughout the life of the culture without detriment to the culture. There is no interference on subsequent measurements of mineralized area due to dye accumulation from repeated application (1).3 Calcified deposits that have been previously stained may appear brighter, but this does not impact the area measurement. Calcein dyes may also be used for this purpose (1) but require a different procedure for analysis than xylenol orange (i.e., concentration and filter sets) and are thus not included here. Alizarin Red and Von Kossa are not suitable for use with this procedure on living cultures since there is no documentation supporting their repeated use in living cultures without deleterious effects. 5.4 The test method may be applied to cultures of any cells capable of producing calcified deposits. It may also be used to document the absence of mineral in cultures where the goal is to avoid mineralization. 5.5 During osteoblast differentiation assays, osteogenic supplements are provided to induce or assist with the differentiation process. If osteogenic supplements are used in excess, a calcified deposit may occur in the cell cultures that is not osteoblast-mediated and thus is referred to as dystrophic, pathologic, or artifactual (2). For example, when higher concentrations of beta-glycerophosphate are used in the medium to function as a substrate for the enzyme alkaline phosphatase secreted by the cells, there is a marked increase in free phosphate, which then precipitates with Ca++ ions in the media to form calcium phosphate crystals independently of the differentiation status of the progenitor cell. Alkaline phosphatase production is associated with progenitor cell differentiation, and is frequently stimulated by dexamethasone addition to the medium, which enhances the formation of calcified deposits. These kinds of calcified/mineral deposits are thus considered dystrophic, pathologic, or artifactual because they were not initiated by a mature osteoblast. The measurement obtained by using this practice may thus result in a potentially false interpretation of the differentiation status of osteoprogenitor cells if used in isolation without gene or protein expression data (3,4). 5.6x00a............

Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis

ASTM E1881-12 用次级离子质谱法 (SIMS) 对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 complement 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 F895-11 细胞培养及毒素屏蔽的标准试验方法

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 F748).1.1 This test method is appropriate for materials in a variety of shapes and for materials that are not necessarily sterile. This test method would be appropriate in situations in which 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 that 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 that 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 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 E1968-11 在对可卡因进行法医分析时所进行的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 (6). 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 (1-5). 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. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard cannot replace knowledge, skill, or ability acquired through appropriate education, training, and experience and should be used in conjunction with sound professional judgment. 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 Guide for Microcrystal Testing in the Forensic Analysis of Cocaine

ASTM D5952-08 军团菌的水系统检查和可能爆发军团病(军团病或庞蒂亚克热)调查的标准指南

Water systems may be inspected (see Section 7) and tested (see Section 8) for legionella under three circumstances (1) in the absence of reported legionellosis (see 5.2); (2) when a single legionellosis case has been reported (see 5.3); and (3) when two or more legionellosis cases are reported in a limited time period and geographic region (see 5.4). Following are factors building owners and operators need to understand when considering testing water systems for legionella in the absence of illness (see 5.2) and for single legionellosis cases (see 5.3). Refer also to the CDC 2003 Guidelines for Preventing Health-Care Associated Pneumonia, and the CDC 2000 Guidelines for Preventing Opportunistic Infections Among Hematopoietic Stem Cell Transplant Recipients, and the WHO Legionella and the Prevention of Legionellosis. Detection of legionella in a water system is not sufficient to identify the system as a health hazard. However, failure to detect legionella does not indicate, conclusively, that the bacterium is not present (see 6.2.4) or that the water system may not pose a potential health hazard. Methods to detect legionella vary in sensitivity and specificity (see 6.2), and laboratories vary in their skill and experience in the isolation and identification of legionella. Isolation of apparently identical legionellae from clinical and environmental samples (see 6.2.1, 6.6.2.4, and Section 8) may suggest that a water system was the source of the legionella responsible for a patient''s infection (see 5.3.2). However, cases of Legionnaires'' disease due to different legionella serogroups or species need not necessarily have different sources of exposure because a system may be contaminated by more than one legionella. Timely inspection, testing, and treatment of possible legionella sources may reduce legal liabilities for facility owners and operators. Refer also to the APHA Public Health Law Manual. Environmental Testing for Legionella in the Absence of Illness: Concerned employers, building owners and operators, facility managers, and others seek to prevent real and potential health hazards, if possible. Water system operators may identify undesirable situations by monitoring routinely for legionella and may be able to implement control measures before the bacterium reaches an amount sufficient to cause human illness (see 6.2.4.2). The CDC 2000 Guidelines for Preventing Opportunistic Infections Among Hematopoietic Stem Cell Transplant Recipients advises that because transplant recipients are at much higher risk for disease and death from legionellosis compared with other hospitalized persons, periodic culturing for legionella in water samples from a center''s potable water supply could be regarded as part of an overall strategy for the prevention of Legionnaires'' disease in transplant centers and other facilities housing persons at high risk of infection if exposed (see 6.4.2). There is some evidence that environmental legionella surveillance should be considered a proactive strategy for the prevention of hospital-acquired Legionnaires’ disease (1). However, the optimal methodology (that is, frequency or number of sites) for environmental surveillance cultures in transplant centers has not been determined, and the cost-effectiveness of such a strategy has not been evaluated for either transplant centers or other health-care settings nor for institutional, commercial, or residential buildings. Some experts advise against testing water systems for legionella in the absence of illness, particularly in buildings other than hospitals or health-care facilities, given that absolute exclusion of this bacterium from water systems may not be necessary to prevent legionellosis nor may it be achiev.......

Standard Guide for the Inspection of Water Systems for Legionella and the Investigation of Possible Outbreaks of Legionellosis (Legionnaires'' Disease or Pontiac Fever)

ASTM E2525-08(2013) 评估形成小鼠粒细胞巨噬细胞集的纳米粒子材料作用的标准试验方法

5.1 Stem cells of hematopoietic origin are pluripotential and may be particularly sensitive to the effects of stimulation by nanoparticulate materials. 5.2 The effect of particles on macrophage responses has an extensive history and can be assessed by Practice F1903. The test method described here will assess the effect on stem cells which can be progenitor cells to the macrophage line. 1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution on granulocyte-macrophage colony-forming units. 1.2 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted. 1.3 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration in medical applications. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies

ASTM E2526-08 测定猪肾细胞和人类肝癌细胞中纳米粒子材料的细胞毒性的标准试验方法

Assessing the propensity of a nanomaterial to cause cytotoxicity to the cells of a target organ can assist in preclinical development. The standard historical cytotoxicity testing of materials and extracts of materials has used fibroblasts and is well documented in Practice F 813, Test Method F 895, and ISO 10993-5. The use of macrophages and micron size particles has also provided information on cytotoxicity and stimulation using Practice F 1903. This test method adds to the cytotoxicity test protocols by using target organ cells. Two quantitative assays measuring LDH leakage and MTT reduction are used to estimate cytotoxicity. This test method may not be predictive of events occurring in all types of nanomaterial applications and the user is cautioned to consider the appropriateness of the test for various types of nanomaterial applications. This procedure should only be used to compare the cytoxicity of a series of related nanomaterials. Meaningful comparison of unrelated nanomaterials is not possible without additional characterization of physicochemical properties of each individual nanomaterial in the assay matrix.1.1 This test method provides a methodology to assess the cytotoxicity of suspensions of nanoparticulate materials in porcine proximal tubule cells (LLC-PK1) and human hepatocarcinoma cells (Hep G2) which represents potential target organs following systemic administration 1.2 This test method is part of the in vitro preclinical characterization cascade. 1.3 This test method consists of a protocol utilizing two methods for estimation of cytotoxicity, 3-(4,5-Dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide (MTT) reduction and lactate dehydrogenase (LDH) release. 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 Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells

ASTM E2526-08(2013) 评估猪肾细胞和人类肝癌细胞中纳米粒子材料细胞毒素的标准试验方法

5.1 Assessing the propensity of a nanomaterial to cause cytotoxicity to the cells of a target organ can assist in preclinical development. 5.2 The standard historical cytotoxicity testing of materials and extracts of materials has used fibroblasts and is well documented in Practice F813, Test Method F895, and ISO 10993-5. The use of macrophages and micron size particles has also provided information on cytotoxicity and stimulation using Practice F1903. 5.3 This test method adds to the cytotoxicity test protocols by using target organ cells. Two quantitative assays measuring LDH leakage and MTT reduction are used to estimate cytotoxicity. 5.4 This test method may not be predictive of events occurring in all types of nanomaterial applications and the user is cautioned to consider the appropriateness of the test for various types of nanomaterial applications. This procedure should only be used to compare the cytoxicity of a series of related nanomaterials. Meaningful comparison of unrelated nanomaterials is not possible without additional characterization of physicochemical properties of each individual nanomaterial in the assay matrix. 1.1 This test method provides a methodology to assess the cytotoxicity of suspensions of nanoparticulate materials in porcine proximal tubule cells (LLC-PK1) and human hepatocarcinoma cells (Hep G2) which represents potential target organs following systemic administration 1.2 This test method is part of the in vitro preclinical characterization cascade. 1.3 This test method consists of a protocol utilizing two methods for estimation of cytotoxicity, 3-(4,5-Dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide (MTT) reduction and lactate dehydrogenase (LDH) release. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells

ASTM F813-07 直接接触细胞培养评估医疗器械材料的标准实施规程

This practice is useful for assessing cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical materials and medical devices. This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays and are frequently more sensitive to toxic moieties. This cell culture test method is suitable for adoption in specifications and standards for materials for use in the construction of medical devices that are intended to be implanted in the human body or placed in contact with tissue, tissue fluids, or blood on a long-term basis. However, care should be taken when testing materials that are resorbable to be sure the method is applicable. Since cells in this direct contact test method are not protected by an overlying agarose layer, they are more susceptible to potential mechanical damage imparted by the overlying test sample. Investigators wishing to evaluate the cytotoxic response of cells underlying the test sample should consider agarose-based methods similar to Test Method F 895. Alternatively, dependent on sample characteristics, extraction methods such as Practice F 619 may also be considered.1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared.1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F 748.1.5 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 a well-characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.1.6 Since the test sample is not removed at the time of microscopic evaluation and underlying cells may be affected by the specific gravity of the test sample, this practice is limited to evaluation of cells outside the perimeter of the overlying test sample.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 Direct Contact Cell Culture Evaluation of Materials for Medical Devices

ASTM E2125-07 苯环哌啶及其相似物的司法分析中微晶体测试的标准指南

The technique produces a chemical-precipitation reaction between the phencyclidine or its analogues and the precipitating reagent. The habit and the aggregation of the crystals formed may be used to distinguish phencyclidine or its analogues from other drugs. The technique can be utilized on phencyclidine or its analogues present in either the salt or free base form. The technique does not distinguish between salt and free base forms.1.1 This guide describes some standard procedures applicable to the analysis of phencyclidine and its analogues using microcrystal tests.1.2 These procedures are applicable to phencyclidme and its analogues which are present in solid dosage form or in a liquid form. They are not typically applicable to the analysis of phencyclidine and its analogues in biological samples.1.3 This guide offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a projects many unique aspects. The word "Standard" in the title of this document means only that the document has been approved through the ASTM consensus process.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 Microcrystal Testing in the Forensic Analysis of Phencyclidine and Its Analogues

ASTM F813-07(2012) 医疗器械材料直接接触细胞培养评价的标准实施规程

1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices. 1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared. 1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques. 1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748. 1.5 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 a well-characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories. 1.6 Since the test sample is not removed at the time of microscopic evaluation and underlying c......

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

ASTM E1326-06 评估细菌计数的非常规微生物试验标准指南

This guide should be used by producers and potential producers of nonconventional tests to determine the accuracy, selectivity, specificity, and reproducibility of the tests, as defined in Practices E 691 and D 3870. Results of such studies should identify the limitations and indicate the utility or applicability of the nonconventional test, or both, for use on different types of samples. Nonconventional test users and potential users should employ this guide to evaluate results of the nonconventional test as compared to their present methods. Practices D 5245 and D 5465 should be reviewed in regards to the conventional microbiological methods employed. If conventional methods have not been used for monitoring the systems, then guidelines are included for obtaining microbiological expertise. Utilization of a nonconventional test may reduce the time required to determine the microbiological status of the system and enable an improvement in the overall operating efficiency. In many cases, the findings of a significantly high level of bacteria indicates the need for an addition of an antimicrobial agent. By accurately determining this in a shorter time period than by conventional methods, treatment with antimicrobial agents may circumvent more serious problems than if the treatment were postponed until conventional results were available. If the antimicrobial treatment program relies on an inaccurate nonconventional test, then unnecessary loss of product and problems associated with inappropriate selection or improper dosing with antimicrobial agents would exist. Since many methods based on entirely different chemical and microbiological principles are considered, it is not possible to establish a unique design and recommend a specific method of statistical analyses for the comparisons to be made. It is only possible to present guides that should be followed while performing the experiments. It is also recommended that a statistician be involved in the study. 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 Count 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 to assist investigators in assessing the accuracy and precision of nonconventional methods intended for the determination of microbial population densities or activities. 1.3 It is recognized that the Heterotrophic Plate Count does not recover all microorganisms present in a product or a system (, ). When this problem occurs during the characterization of a microbiological population, alternative 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 alternative standard procedures may be the only means available for establishing correlation. In such cases, this guide can serve as a reference......

Standard Guide for Evaluating Nonconventional Microbiological Tests Used for Enumerating Bacteria

ASTM E1881-06 用次级离子质谱法(SIMS)进行细胞培养分析的标准指南

The presence of cell growth medium complicates a direct analysis of cells with SIMS. Attempts to wash out the nutrient medium results in the exposure of cells to unphysiological reagents that may also alter their chemical composition. This obstacle is overcome by using a sandwich freeze-fracture method (1). This cryogenic method has provided a unique way of sampling individual cells in their native state for SIMS analysis. The procedure described here has been successfully used for imaging Na+ and K+ ion transport (3), calcium alterations in stimulated cells (4,5), and localization of therapeutic drugs and isotopically labeled molecules in single cells (6). The frozen freeze-dried cells prepared according to this method have been checked for SIMS matrix effects (7). Ion image quantification has also been achieved in this sample type (8). The procedure described here is amenable to a wide variety of cell cultures and provides a way for studying the response of individual cells for chemical alterations in the state of health and disease and localization of isotopically-labeled molecules and theraputic drugs in cell culture models.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 complement 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.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 D5952-02 军用住处的可中断调查和军用住处的检验水系统用标准指南

1.1 This guide covers appropriate responses for employers, building owners and operators, facility managers, health and safety professionals, public health authorities, and others: (1) to a concern that a manmade water system may be contaminated with the bacteria known as legionellae (see 6.1); and (2) to the identification of one or more cases of Legionnaires' disease or Pontiac fever due to inhalation of airborne legionellae (see 6.3-6.5). Comprehensive and explicit recommendations to limit legionella multiplication in water systems and to disinfect potential sources of human exposure to legionellae are beyond this guide's scope. 1.2 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. See 7.3 and 8.5 for specific hazard statements.

Standard Guide for Inspecting Water Systems for Legionellae and Investigating Possible Outbreaks of Legionellosis (Legionnaires' Disease or Pontiac Fever)

ASTM E2125-01 苯环哌啶及其相似物的司法分析中微晶体测试的标准指南

1.1 This guide describes some standard procedures applicable to the analysis of phencyclidine and its analogues using microcrystal tests.1.2 These procedures are applicable to phencyclidme and its analogues which are present in solid dosage form or in a liquid form. They are not typically applicable to the analysis of phencyclidine and its analogues in biological samples.

Standard Guide for Microcrystal Testing in the Forensic Analysis of Phencyclidine and Its Analogues

ASTM E1285-01 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 (955;) or Its DNA

ASTM F813-01 医疗器械材料直接接触细胞培养评估标准实践

1.1 This practice describes a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices. 1.2 This method may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared. 1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques. 1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F 748. 1.5 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. 1.6 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.

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

ASTM E1286-00 单纯疱疹病毒或它的脱氧核糖核酸的识别用标准指南

1.1 This guide covers laboratory characterization procedures sufficient to identify purified specimens of HSV types 1 and 2 (HSV-1 and HSV-2) or HSV-1 DNA and HSV-2 DNA used in biotechnology. For cases in which identification of HSV DNA specimens is required, the characterization criteria of 6.2 and 6.3 of this guide are sufficient.1.2 This guide does not cover the identification of HSV in HSV-infected host cells. To apply this guide to such a case, it would first be necessary to isolate the virus from such samples using standard techniques of HSV purification. This guide does not cover characterization of segments of HSV DNA or of vectors containing HSV DNA segments.1.3 This guide does not cover the specific methodology used in the identification characterization. It does not address the question of degree of purity required for herpesvirus preparations: this would vary depending on the particular biotechnology use of the virus.1.4 Warning--Laboratory work involving herpes simplex viruses can be hazardous to personnel. Precaution: Biosafety 2 level facilities are recommended (1). Safety guidelines shall be adhered to according to NCCLS M29-T2 and other recommendations (1).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 Guide for Identification of Herpes Simplex Virus or its DNA

ASTM E1532-00 用二苯甲酰胺与DNA结合荧光染料法检测细胞培养中支原体污染物的标准实施规程

1.1 This practice covers procedures used for the detection of mycoplasma contamination by DNA staining. 1.2 This practice does not cover cultivation methods for the detection of mycoplasma or other methods such as biochemical detection, hybridization methodology, histochemical stains, or immunochemical methods. 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 Detection of Mycoplasma Contamination of Cell Cultures by Use of the Bisbenzamide DNA-Binding Fluorochrome