07.100.10 - Medical microbiology
ICS 07.100.10 Details
Medical microbiology
Medizinische Mikrobiologie
Microbiologie médicale
Medicinska mikrobiologija
General Information
Frequently Asked Questions
ICS 07.100.10 is a classification code in the International Classification for Standards (ICS) system. It covers "Medical microbiology". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 115 standards classified under ICS 07.100.10 (Medical microbiology). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.
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SIGNIFICANCE AND USE
4.1 Single-use systems (SUSs) used for biopharmaceutical manufacturing must maintain sterility and product quality of the fluid inside. Such articles or systems should therefore be validated as providing an effective barrier against microbial ingress. The microbial barrier properties of a SUS may be demonstrated using deterministic physical tests that have been correlated to microbial integrity. Such physical test methods are described in Test Method E3336. Two microbial test methods (aerosol exposure and immersion exposure) are described in this test method that can be used to demonstrate microbial integrity of a SUS or determine the MALL, the maximum defect size that does not allow microbial ingress, into a SUS.
4.2 It is important to note that the results of microbial ingress tests are heavily dependent on the conditions under which the test is performed and are not suitable for routine checking of a SUS due to the test’s destructive nature.
4.2.1 Any size defect may be forced to fail under sufficiently aggressive conditions (including a large enough sample size, high differential pressure, or high hydrostatic pressure, for example) that would not ordinarily reflect normal use conditions. Thus, it is necessary to clearly define the relevant conditions for a test through a risk assessment of both the actual SUS claims and its final use (Practice E3244). Once that is established, the size of defect that can be detected under those conditions can be determined, if required, using defined defects.
4.2.2 “Relevant conditions” refers to worse-case actual use conditions but does not mean that a SUS must be tested under theoretically absolute (extreme) “worst-case” conditions.
4.2.3 Testing may be performed on individual components or entire systems. Considerations for defining “relevant conditions” and testing design should be based on a risk assessment for the SUS intended use and should include:
4.2.3.1 A channel created by a defect or breach through the...
SCOPE
1.1 The microbial test method outlined in this test method applies to microbial ingress risk assessment of a single-use system (SUS) or its individual components that require integrity testing either by the assembly supplier or the end user of the assembly based on a potential risk of a breach to the product or manufacturing process.
1.2 The aim of microbial ingress testing of sterile SUSs used in biopharmaceutical manufacturing is two-fold:
1.2.1 Firstly, it is used to evaluate the ability of a SUS fluid path to remain sterile after a SUS has been challenged by microbial exposure. Microbial exposure is achieved either by directly placing a SUS into a container of microbial challenge solution, or by delivering an aerosolized microbial challenge onto a SUS that is placed inside a test chamber designed to generate and deliver the aerosol. The choice of the test challenge organism should be justified based on a risk assessment of the SUS and conditions of use.
1.2.2 Additionally, microbial ingress testing can be used to determine the maximum allowable leakage limit (MALL) that does not allow microbial ingress under specific test conditions. The defect size that can be detected by specific physical integrity testing methods (see Test Method E3336) can be correlated to this MALL in order to claim microbial integrity. Test articles bearing calibrated defects over a range of dimensions, including up to a defect size expected to consistently allow microbial ingress as a positive control (defect-based positive control), may be tested to determine the MALL.
1.3 Both purposes for microbial ingress testing as described in 1.2.1 and 1.2.2 can either be conducted by liquid immersion or aerosol exposure. For the purpose described in 1.2.2, the type of exposure should be determined according to the SUS’s use-case conditions and a risk assessment.
1.4 The method used to create a breach, hole or defect in single-use film or...
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SIGNIFICANCE AND USE
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.
SCOPE
1.1 This test method provides a protocol for quantitative analysis of the effect of nanoparticulate materials in physiologic solution (isotonic, pH 7.2 ± 0.2) on granulocyte-macrophage colony-forming units (CFU-GM).
1.2 CFU-GM reflects the number of viable bone marrow cells which differentiate into granulocytes and macrophages. A decrease in CFU-GM count is indicative of a test substance’s toxicity to bone marrow and is commonly used for the identification of drug products with myelosuppressive properties, a form of immunosuppression.
1.3 This test method employs murine bone marrow hematopoietic stem cells which proliferate and differentiate to form discrete cell clusters or colonies which are counted.
1.4 This test method is part of the in vitro preclinical characterization cascade for nanoparticulate materials for systemic administration in medical applications.
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.
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SIGNIFICANCE AND USE
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 and their 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.
SCOPE
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 represent potential target organs following systemic administration.
1.2 This test method is part of an 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 In-vitro osteoblast differentiation assays are one approach to screen progenitor stem cells for their capability to become osteoblasts. The extent of calcium deposits or mineralized matrix that form in vitro may be an indicator of differentiation to a functional osteoblast; however, 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 practice 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, XO. 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 ensure that the images have not been underexposed or overexposed. Intensity and area do not correlate directly to calcium content.
5.3 XO enables the monitoring of calcium deposits repeatedly throughout the life of the culture without detriment to the culture. There is no interference on subsequent measurements of the mineralized area due to dye accumulation from repeated application (1).3 Calcium 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 XO (that is, 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 practice may be applied to cultures of any cells capable of producing calcium 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 ...
SCOPE
1.1 This practice defines a method for the estimation of calcium content at multiple time points in living cell cultures that have been cultured under conditions known to promote mineralization. The practice involves applying a fluorescent calcium-chelating dye that binds to the calcium phosphate mineral crystals present in the live cultures followed by image analysis of fluorescence microscopy images of the stained cell cultures. Quantification of the positively stained areas provides a relative measure of the calcium content in the cell culture plate. A precise correlation between the image analysis parameters and calcium content is beyond the scope of this practice.
1.2 Calcium deposition in a secreted matrix is one of several features that characterize bone formation (in vitro and in vivo), and is therefore a parameter that may indicate bone formation and osteoblast function (that is, osteoblastic differentiation). Calcium deposition may, however, be unrelated to osteoblast differentiation status if extensive cell death occurs in the cell cultures or if high amounts of osteogenic medium components that lead to artifactual calcium-based precipitates are used. Distinguishing between calcium deposition associated with osteoblast-produced mineralized matrix and that from pathological or artifactual deposition requires additional structural and chemical characterization of the mineralized matrix and biological characterization of the cell that is beyond the scope of this practice.
1.3 The parameters obtained by image analysis are expressed in relative fluorescence units or area percentage (area%), for example, fraction of coverage of the area analyzed.
1.4 Units—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 responsibili...
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1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.
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SIGNIFICANCE AND USE
5.1 This guide should be used by producers and potential producers of non-culture tests to determine the accuracy, selectivity, specificity, and precision 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. Guide E1488 recommends other statistical tools for evaluating the suitability and applicability of proposed new test methods.
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 diff...
SCOPE
1.1 The purpose of this guide is to assist users and producers of non-culture microbiological 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. Moreover, any given culture test method typically recovers only a portion 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, under specified growth conditions. Non-culture test methods attempt to provide the same or complimentary information through the measurement of a different parameter. This guide is designed to assist investigators in assessing the accuracy and precision of non-culture methods intended for the determination of microbial population densities or activities.
1.3 It is recognized that the Heterotrophic Plate Count (HPC) does not recover all microorganisms present in a product or a system (1, 2).2 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, the utilization of contaminated product components or genetic profile of the microbial population might be indicated. In evaluating non-culture tests, it is possible that the use of these alternative standard procedures might be...
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SIGNIFICANCE AND USE
5.1 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.
5.2 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).
5.3 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.
SCOPE
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
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SIGNIFICANCE AND USE
4.1 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.
4.2 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 when only chemical toxicities are being considered.
Note 1: The results obtained using this method may not predict in vivo behavior which can be influenced by multiple factors such as those arising from site of application or physical properties that may result from design and fabrication.
4.3 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 have direct contact with tissue, tissue fluids, or blood. However, care should be taken when testing materials that are absorbable, include an eluting or degradable coating, are liquid or gelatinous in nature, are irregularly shaped solid materials, or have a high density or mass, to make sure that the method is applicable. If leachables from the test sample are capable of diffusing through the agar layer, agarose-based methods such as Test Method F895 may be considered as an alternate method, depending on sample characteristics, or in cases where investigators wish to further evaluate the cytotoxic response of cells underlying the test sample.
SCOPE
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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
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SIGNIFICANCE AND USE
5.1 This technique involves a chemical-precipitation reaction between cocaine and the precipitating reagent. The habit and the aggregation of the crystals formed could be used to distinguish cocaine from other drugs (6).
5.2 This technique can be utilized on cocaine present in either the salt or free base form.
5.3 This technique does not distinguish between the salt and free base forms.
SCOPE
1.1 This practice describes procedures applicable to the analysis of cocaine using multiple microcrystal tests (1-6).2
1.2 These procedures are applicable to cocaine, which is present in solid 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 These procedures could generate observations indicating a positive test for cocaine or its enantiomers which could be incorporated into the analytical scheme as defined by the laboratory.
1.5 This standard cannot replace knowledge, skills, or abilities acquired through appropriate education, training, and experience (see Practice E2326) and is to be used in conjunction with professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.
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.
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SIGNIFICANCE AND USE
5.1 This technique involves a chemical-precipitation reaction between the phencyclidine or its analogues and the precipitating reagent. The habit and the aggregation of the crystals formed could be used to distinguish phencyclidine or its analogues from other drugs.
5.2 This technique can be utilized on phencyclidine or its analogues present in either the salt or free base form.
5.3 This technique does not distinguish between salt and free base forms.
SCOPE
1.1 This practice describes procedures applicable to the analysis of phencyclidine and its analogues using microcrystal tests (1-8).2
1.2 These procedures are applicable to phencyclidine and its analogues which are present in solid form or in a liquid form. They are not typically applicable to the analysis of phencyclidine and its analogues 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 These procedures could generate observations indicating a positive test for phencyclidine and its analogues which could be incorporated into the analytical scheme as defined by the laboratory.
1.5 This standard cannot replace knowledge, skills, or abilities acquired through appropriate education, training, and experience (see Practice E2326) and is to be used in conjunction with sound professional judgment by individuals with such discipline-specific knowledge, skills, and abilities.
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.
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SIGNIFICANCE AND USE
5.1 The propensity of a material to stimulate delayed contact hypersensitivity must be assessed before clinical application of devices containing this material. Delayed hypersensitivity may occur anywhere in the body. Systemic delayed hypersensitivity may have a complex set of reactions and consequences depending on the actual tissue/organ site of reaction. Although the reactions are seldom life-threatening, severe tissue and organ damage my result over time. Skin is the usual test site to determine the propensity of a material to cause delayed hypersensitivity.
5.2 The standard historical test methods have involved the use of guinea pigs with a cutaneous application and observation of the reaction site. The use of the murine local lymph node assay results in a numerical quantitation of stimulation, rather than subjective evaluation and could be used to determine dose responses.
5.3 This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
SCOPE
1.1 This practice provides a methodology to use a combination of in vivio and in situ procedures for the evaluation of delayed contact hypersensitivity reactions.
1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. This practice may be used for testing metals, with the exception of nickel-containing metals, unless the unique physicochemical properties of the materials may interfere with the ability of LLNA to detect sensitizing substances.
1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation in the lymph nodes draining the site of test article administration on the ears of mice.
1.4 The LLNA has been validated only for low-molecular-weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates.
1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply a single source. Appropriate materials and reagents may be obtained from many commercial supply houses.
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 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.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
- Standard58 pagesEnglish languagee-Library read for1 day
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
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SIGNIFICANCE AND USE
4.1 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.
4.2 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.
4.3 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.
4.4 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).
SCOPE
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.
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SIGNIFICANCE AND USE
4.1 This classification was developed to permit the addition of descriptive symbols and values for further new formulations with improved properties without complete reorganization of the standard and to facilitate the incorporation of future new test methods to keep pace with changing industry requirements.
SCOPE
1.1 This classification provides guidance to engineers and users in the selection of practical vinyl chloride plastics for medical applications and further provides a method for specifying these materials by use of a simple line call-out designation. This classification excludes vinyl chloride plastics used in long-term implants.
1.2 Use is made of a classification scheme based on the premise that the composition of vinyl chloride plastics, copolymers, fillers, plasticizers, stabilizers, and other additives in these systems can be arranged into characteristic material designations.
1.3 In all cases where the provisions of this classification system would conflict with those of the detailed specification for a particular device, the latter shall take precedence.
Note 1: For cases in which the vinyl chloride plastic may be used for purposes where the requirements are too specific to be completely described by this classification system, it is advisable for the purchaser to consult the supplier to secure adjustment of the properties to suit the actual conditions to which the device is to be subjected.
1.4 The biocompatibility of vinyl chloride plastics as a class of materials has not been established. Since many compositions and formulations fall under this class, it is essential that the fabricators/device manufacturers assure the safety and efficacy of the specific composition or formulation, in its intended application, using state-of-the-art test methods.
1.5 This classification is to assist the interface between the material supplier and the device manufacturer (fabricator) who purchases a formulated vinyl chloride plastic for a component. For those device manufacturers (fabricators) who do their own formulating, compounding, extrusion, molding, and so forth, this classification does not apply.
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.
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Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.
- Amendment10 pagesEnglish languagee-Library read for1 day
Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 5/1999) (CC/990525)
- Amendment3 pagesEnglish languagee-Library read for1 day
Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 5/1999) (CC/990525)
2020-01-20: Originator of XML version: NEN (on behalf of NEN, ASI, DS, SFS, SIS, SN)
- Amendment3 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.
- Standard13 pagesEnglish languagee-Library read for1 day
This European Standard provides terms for different classifications of culture media used in microbiology (bacteriology and mycology).
- Standard4 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.
- Standard13 pagesEnglish languagee-Library read for1 day
This European Standard provides terms for different classifications of culture media used in microbiology (bacteriology and mycology).
- Standard4 pagesEnglish languagee-Library read for1 day
This document describes the minimum requirements for bacteriophage preparation processing including the assessment of the titer and quality control. This document applies to data processing of bacteriophage isolation, culture, purification and storage. This document applies to the quality evaluation/assessment of bacteriophage used for therapy.
- Draft18 pagesEnglish languagesale 15% off
- Draft18 pagesEnglish languagesale 15% off
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
- Standard27 pagesEnglish languagee-Library read for1 day
ISO - Taking over of an ISO Technical Corrigendum
- Corrigendum3 pagesEnglish languagee-Library read for1 day
ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.
- Standard44 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 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.
5.2 Environmental Testing for Legionella in the Absence of Illnes...
SCOPE
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 water system may be contaminated with the bacterium known as legionella (see 6.1); and (2) to the identification of one or more cases of Legionnaires' disease or Pontiac fever (see 6.3 – 6.5). Comprehensive and explicit recommendations to limit legionella multiplication in water systems, disinfect potential sources of human exposure to legionella, and prevent health-care associated infections are beyond this guide's scope.
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 and health practices and determine the applicability of regulatory limitations prior to use. See 7.3 and 8.5 for specific hazard statements.
WITHDRAWN RATIONALE
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 water system may be contaminated with the bacterium known as legionella; and (2) to the identification of one or more cases of Legionnaires' disease or Pontiac fever.
Formerly under the jurisdiction of Committee D22 on Air Quality, this guide was withdrawn in January 2024 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
- Guide17 pagesEnglish languagesale 15% off
- Guide17 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide applies to the determination of the safety of non-metallic materials used in contact with biotechnology product containing solutions. Process materials leach low level of residues into water, cell culture media, buffers, and other product containing solutions. This document offers guidance on determining the safety of these materials (process materials) for use. The goal is to prevent toxic extractables from entering process streams and ultimately contaminating the final product in unacceptable levels.
4.2 The purpose of this guide is to describe tests to qualify materials with respect to any extractable substances so as to prevent unintentional introduction of a potential source of objectionable substances. An extractable material is objectionable if it is toxic, interacts with product constituents, interferes with required assays, or otherwise affects the process stream so as to adversely affect critical quality parameters, for example, purity, safety, efficacy, identity, strength of the final product or its successful production. All organizations producing pharmaceutical products should consider the points in this guide when qualifying process materials for use in their production processes.
4.3 This guide outlines the application of the process material tests primarily in ASTM or USP. Typical process materials include high molecular weight polymers and solids such as hoses, filters, filter housings, containers, valve diaphragms, gaskets, o-rings, chromatography resins, and chromatographic columns.
4.4 The battery of tests described in this guide is intended to cover a wide variety of potential attributes of materials and to characterize possible extractables.
4.5 The material specification will vary depending on the impact on the final product and the point in the process that the product solution contacts the material. Tighter specifications should be considered for extractables for final product purification process materials than f...
SCOPE
1.1 This guide covers procedures and test methods for process component qualification by the end user. The goal is to assess the safety impact of extractables from non-metallic process components used in contact with bioprocessing solutions. This encompasses the impact of extractables on the safety of the final product as it passes through the various stages of the manufacturing process. This guide is not designed for evaluation of metallic materials, final product container/closures or those components intentionally added to the product or production streams during the manufacturing process. Testing of solids and extracts is specified in other ASTM standards. Materials must be qualified by specific use.
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 There is no companion guide available.
1.4 Safety/Fire Hazards: Extractions with organic solvents will be infrequent under this guide, but, when used must be treated as potential fire/explosion hazards.
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.
WITHDRAWN RATIONALE
This guide covers procedures and test methods for process component qualification by the end user. The goal is to assess the safety impact of extractables from non-metallic process components used in contact with bioprocessing solutions. This encompasses the impact of extractables on the safety of the final product as it passes through the various stages of the manufacturing process. This guide is not designed for evaluation of metallic materials, final product container/closures or those components intentionally added to the product or production streams during the manufacturi...
- Guide5 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 The use of statistical analysis will enable the investigator to make better, more informed decisions when using the information derived from the analyses.
4.1.1 The goals when performing statistical analyses, are to summarize, display, quantify, and provide objective measures for assessing the relationships and anomalies in data. Statistical analyses also involve fitting a model to the data and making inferences from the model. The type of data dictates the type of model to be used. Statistical analysis provides the means to test differences between control and treatment groups (one form of hypothesis testing), as well as the means to describe the relationship between the level of treatment and the measured responses (concentration effect curves), or to quantify the degree of uncertainty in the end-point estimates derived from the data.
4.1.2 The goals of this practice are to identify and describe commonly used statistical procedures for toxicity tests. Fig. 1, Section 6, following statistical methods (Section 5), presents a flow chart and some recommended analysis paths, with references. From this guideline, it is recommended that each investigator develop a statistical analysis protocol specific to his test results. The flow chart, along with the rest of this guideline, may provide both useful direction, and service as a quality assurance tool, to help ensure that important steps in the analysis are not overlooked.
FIG. 1 Flow Chart for Practice for Statistical Analysis
FIG. 1 Flow Chart for Practice for Statistical Analysis (continued)
FIG. 1 Flow Chart for Practice for Statistical Analysis (continued)
FIG. 1 Flow Chart for Practice for Statistical Analysis (continued)
SCOPE
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:
Title
Section
Referenced Documents
2
Terminology
3
Significance and Use
4
Statistical Methods
5
Flow Chart
6
Flow Chart Comments
7
Keywords
8
References
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.
WITHDRAWN RATIONALE
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...
- Standard10 pagesEnglish languagesale 15% off
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
- Standard27 pagesEnglish languagee-Library read for1 day
ISO - Taking over of an ISO Technical Corrigendum
- Corrigendum3 pagesEnglish languagee-Library read for1 day
ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.
- Standard44 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
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.
SCOPE
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.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
WITHDRAWN RATIONALE
The purpose and scope of this guide was 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)) could be properly understood and evaluated.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in November 2014. This standard is being withdrawn without replacement due to its limited use by industry.
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SIGNIFICANCE AND USE
Mycoplasmas of bovine origin are prevalent contaminants of cell cultures. Contamination can be detected by the large volume method.3 ,4
Heat inactivated serum need not be tested for mycoplasmas. Heating serum to 56°C for 30 min will kill mycoplasmas.
Mycoplasmas may be present in any particular lot of serum but may not be detected because of inadequate sample size; thus, negative test results do not provide absolute assurance that the test serum is free of mycoplasmas.
SCOPE
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.
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.
WITHDRAWN RATIONALE
This practice covers the procedures used for detection of mycoplasma contamination in serum by direct microbiological culture.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
- Standard2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
This guide is intended for use in a biotechnology laboratory whenever the necessity arises for identifying a biological preparation believed to contain primarily HSV or its DNA. The characterization criteria used for the identification shall be performed by an individual trained in molecular virology.
This guide is not meant to be used in a clinical laboratory for the identification of HSV isolated from patient specimens.
SCOPE
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 and 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 herpes virus 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. Biosafety 2 level facilities are recommended (). Safety guidelines shall be adhered to according to NCCLS M29-T2 and other recommendations ().
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.
WITHDRAWN RATIONALE
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.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this guide was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
- Guide3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
Mycoplasma contamination of cell cultures is a common problem that can affect the growth, metabolism, and function of cultured animal cells. The ability to detect mycoplasma in cell cultures provides an opportunity to ensure that cells are free of contamination, and to replace those that are not. For additional information, see Practices E 1531, E 1532, and E 1536. Strict adherence to established, well-tested procedures is necessary. This practice was developed by Task Group E48.01.02 to assist in developing and maintaining an established regimen for mycoplasma detection by indirect 4′-6-Diamidino-2-Phenylindole (DAPI) fluorochrome staining.
This practice is intended for use in examining cultured animal cells for the presence of mycoplasma contamination.
This practice is not intended for use in the detection of mycoplasma contamination in serum, culture media, or systems other than cultures of animal cells.
All cell cultures to be examined for mycoplasma should undergo a minimum of two passages in antibiotic-free tissue culture medium before testing.
SCOPE
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.
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.
WITHDRAWN RATIONALE
This practice covers procedures used for the detection of mycoplasma contamination by indirect DNA staining.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
Mycoplasma hyorhinis, cultivar α strains (1)3 do not grow on any of the standard media used for mycoplasma cultivation. These strains, which are found as contaminants in cell cultures, are detected by indirect methods.
A specialized medium has been described but it is not yet in wide use (2).
This practice should be used in conjunction with Practice E 1531.
All cell cultures to be examined for mycoplasma should undergo a minimum of two passages in antibiototic-free tissue culture medium before testing.
SCOPE
1.1 This practice covers the use of cell cultures and DNA-binding flurorochrome techniques to detect mycoplasma contamination of cell cultures.
1.2 This practice does not cover axenic cultivation or identification of mycoplasmas.
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.
WITHDRAWN RATIONALE
This practice covers the use of cell cultures and DNA-binding flurorochrome techniques to detect mycoplasma contamination of cell cultures.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this practice was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
- Standard2 pagesEnglish languagesale 15% off
ABSTRACT
This guide covers laboratory characterization procedures for identifying bacteriophage lambda or its DNA and assumes that the reader has basic knowledge in virology and molecular biology. Bacteriohage lambda is a temperate bacteriophage with an icosahedral hear and a single, non-contractile tail ending in a single tail fiber. The lambda genome consists of a single molecule of linear double-stranded DNA and has cohesive ends. The naturally preferred hosts is Escherichia coli K12. Hundreds of lambda variants derived from wild type lambda can be used in biotechnology and differ in genome size and genotype. These are used primarily as DNA vectors for cloning DNA fragments. Judging uncontaminated, pure lambda should be done through restriction enzyme analysis DNA characterization and the presence and identification of lambda DNA is accomplished by polymerase chain reaction. The primers used for detection of bacteriophage lambda should be chosen based on the reason for detection.
SCOPE
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.
WITHDRAWN RATIONALE
This guide covers the procedures for identifying bacteriophage lambda used in biotechnology.
Formerly under the jurisdiction of Committee E55 on Manufacture of Pharmaceutical Products, this guide was withdrawn in August 2014. This standard was withdrawn without replacement due to its limited use by the industry.
- Guide2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
This test method will yield data that will form a performance profile for an anaerobic digester facility. The significance of this profile is that it can be compared directly to another facility’ performance profile and yield a measurement of expected facility performance under field conditions.
This test method will also yield data that can be used to verify the operation of a system to a regulatory agency.
The single black box technique applied to performance evaluation examines only the overall input/output relationship. This implies that the operation of the facility during the tests will be conducted to achieve design conditions in accordance with established procedures.
SCOPE
1.1 This test method is applicable to all anaerobic digestion systems.
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.
WITHDRAWN RATIONALE
This test method is applicable to all anaerobic digestion systems.
Formerly under the jurisdiction of Committee E48 on Biotechnology, this test method was withdrawn in May 2011 with no replacement because it evaluates the performance of process and is no longer relevant.
- Standard4 pagesEnglish languagesale 15% off
- Standard15 pagesEnglish languagee-Library read for1 day
- Standard15 pagesEnglish languagee-Library read for1 day
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
- Standard16 pagesEnglish languagesale 15% off
- Standard17 pagesFrench languagesale 15% off