07.100.99 - Other standards related to microbiology

Evaluation of bactericidal activity of a non-porous antimicrobial surface used in a dry environment

ISO 7581:2023(Main)

This document specifies the test conditions and the levels of activity to determine the bactericidal activity of non-porous surfaces used in a dry environment. It defines a protocol to validate the bactericidal character of a surface and to measure its performance. It is not intended to be used to substantiate cleaning or disinfecting properties. This document is applicable to surfaces claiming to have an activity against vegetative bacteria. The obligatory test conditions are defined in this document. It does not apply to porous surfaces. It does not refer to methods for testing the toxicological and ecotoxicological properties of the surfaces. This document is used to measure bactericidal action, not bacteriostatic activity of a surface.

Standard
24 pages
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Standard
25 pages
French language
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05-Dec-2023
07.100.99
ISO/TC 330

Standard Practice for Enumeration of Mycobacteria in Metalworking Fluids by Direct Microscopic Counting (DMC) Method

ASTM E2564-23(Practice)

SIGNIFICANCE AND USE
5.1 Measurement of mycobacterial cell count densities is an important step in establishing a possible relationship between mycobacteria and occupational health-related allergic responses, for example, hypersensitivity pneumonitis (HP) in persons exposed to aerosols of metalworking fluids. It is known that the viable mycobacteria count underestimates the total mycobacterial levels by not counting the non-culturable, possibly dead or moribund population that is potentially equally important in the investigation of occupational health-related problems. The direct microscopic counting method (DMC) described here gives a quantitative assessment of the total numbers of acid-fast bacilli. It involves using acid-fast staining to selectively identify mycobacteria from other bacteria, followed by enumeration or direct microscopic counting of a known volume over a known area. Although other microbes—particularly the Actinomycetes—also stain acid-fast, they are differentiated from the mycobacteria because of their morphology and size. Non-mycobacteria, acid-fast microbes are 50 to 100 times larger than mycobacteria. This practice provides quantitative information on the total (culturable and non-culturable viable, and non-viable) mycobacteria populations. The results are expressed quantitatively as mycobacteria per mL of metalworking fluid sample.
5.2 The DMC method using the acid-fast staining technique is a semi-quantitative method with a relatively fast turnaround time.
5.3 The DMC method can also be employed in field survey studies to characterize the changes in total mycobacteria densities of metalworking fluid systems over a long period of time.
5.4 The sensitivity detection limit of the DMC method depends on the MF and the sample volume (direct or centrifuged, etc.) examined.
SCOPE
1.1 This practice describes a direct microscopic counting method (DMC) for the enumeration of the acid-fast stained mycobacteria population in metalworking fluids. It can be used to detect levels of total mycobacteria population, including culturable as well as non-culturable (possibly dead or moribund) bacterial cells. This practice is recommended for all water-based metalworking fluids (Classification D2881).
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For additional safety information, see Laboratory Safety: Principle and Practices, 4th Edition.2
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard
4 pages
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Standard
4 pages
English language
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30-Sep-2023
07.100.99
75.100
E34

ASTM D7818-23(Test Method)

Standard Test Method for Enumeration of Proteolytic Bacteria in Fresh (Uncured) Hides and Skins

SIGNIFICANCE AND USE
4.1 This test method enumerates proteolytic bacteria. Proteolytic bacteria have been known to cause damage to hides and skins.
SCOPE
1.1 This test method covers the enumeration of bacteria that can hydrolyze protein/collagen in fresh (uncured) hides and skins. This test method is applicable to uncured hides and skins.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard
7 pages
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Standard
7 pages
English language
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31-Aug-2023
07.100.99
D31

ASTM D7816-23(Test Method)

Standard Test Method for Enumeration of Halophilic and Proteolytic Bacteria in Raceway Brine, Brine-Cured Hides and Skins

SIGNIFICANCE AND USE
4.1 This test method enumerates salt tolerant (halophilic) bacteria, and proteolytic bacteria that are also salt tolerant. Under the conditions of this test method those bacteria are equated as halophilic organisms. Salt tolerant proteolytic bacteria have been known to cause damage to hides and skins in raceway brine.
SCOPE
1.1 This test method covers the enumeration of bacteria that can tolerate high salt concentrations or can hydrolyze protein/collagen, or both. This test method is applicable to raceway brine, brine-cured hides and skins, and pre-charge raceway liquor.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard
7 pages
English language
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Standard
7 pages
English language
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31-Aug-2023
07.100.99
D31

Safety of toys - Part 12: Microbiological safety

ISO 8124-12:2023(Main)

This document specifies acceptable criteria for microbiological cleanliness and adequacy of preservation of the specified toy materials. The requirements in this document apply to all toys that are, contain or are supplied with aqueous materials (e.g. paste, putty, liquid or gel). In addition, this document applies to toys that are or include a cosmetic (including those intended for use on a toy as well as on the child). Powders and similar substances intended to be mixed with water are also within the scope of this document. The cleanliness and preservation effectiveness requirements are applicable to a toy as it is initially received by the consumer in an unopened and undamaged container and do not apply after a toy is subjected to reasonably foreseeable conditions of normal use and abuse, unless specifically noted otherwise. The microbial limits and test methods contained in this document are inappropriate to apply to products that are consumer complaint returns, as there is no way to establish what conditions the toys have been subject to before being returned. The following are excluded from the scope of this document: - materials that are inaccessible during normal use or reasonably foreseeable abuse; - powder or powder-like materials intended to show biological phenomena, e.g. shrimp eggs, seeds, soil; - food.

Standard
7 pages
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ASTM E2471-23(Test Method)

Standard Test Method for Using Seeded-Agar for the Screening Assessment of Antimicrobial Activity In Carpets

SIGNIFICANCE AND USE
5.1 This test method provides for rapid screening of antimicrobial treatments located in or on the carpet face fiber or incorporated into the backing structure of the carpet (or both).
5.2 This test method simulates actual use conditions that may occur on carpets (for example, food and beverage spills, soiling from foot traffic, prolonged moisture exposure).
5.3 This test method provides a means to screen for activity and durability of an antimicrobial treatment under conditions of organic loading.
5.4 This test method provides for the simultaneous assessment of multiple carpet components for antimicrobial activity.
5.5 Carpets may be cleaned prior to testing with this test method in order to assess the durability of the antimicrobial effect.
SCOPE
1.1 This test method is designed to evaluate (qualitatively) the presence of antimicrobial activity in or on carpets. Use this test method to qualitatively evaluate both antibacterial and antifungal activity.
1.2 Use half strength (nutrient and agar) tryptic soy agar as the inoculum vehicle for bacteria and half strength potato dextrose agar as the inoculum vehicle for mold conidia. Use of half strength agars may reduce undue neutralization of an antimicrobial due to excessive organic load.
1.3 This test method simultaneously evaluates (both visual and stereo-microscopic) antimicrobial activity both at the fiber layer and at the primary backing layer of carpet.
1.4 Use this test method to assess the durability of the antimicrobial treatments on new carpets, and on those repeatedly shampooed or exposed to in-use conditions.
1.5 Knowledge of microbiological techniques is required for the practice of this test method.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard
5 pages
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Standard
5 pages
English language
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31-May-2023
07.100.99
97.150
E35

Pulp, paper and board - Microbiological examination - Part 2: Enumeration of bacteria, yeast and mould on surface

ISO 8784-2:2023(Main)

This document specifies a method for determining the bacteria, yeast and mould population on the surface of paper and paperboard. The enumeration relates to specific media. This document is applicable to all kinds of paper and paperboard, to dry market pulp in sheet form and to packaging material.

Standard
5 pages
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Standard
6 pages
French language
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Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure

ASTM E2315-23(Guide)

SIGNIFICANCE AND USE
5.1 This procedure may be used to assess the in vitro reduction of a microbial population of test organisms after exposure to a test material.
SCOPE
1.1 This guide covers an example of a method that measures the changes in a population of aerobic microorganisms within a specified sampling time when antimicrobial test materials are present.
1.1.1 Several options for organism selection and growth, inoculum preparation, sampling times and temperatures are provided.
1.1.2 When the technique is performed as a specific test method, it is critical that the above mentioned variables have been standardized.
1.1.3 Antimicrobial activity of specific materials, as measured by this technique, can vary significantly depending on variables selected.
1.1.4 Test Method E2783 may be referenced as an example of using fixed conditions and set variables to evaluate antimicrobial efficacy of water-miscible compounds.
1.1.5 This guide serves as a general teaching document for evaluating the antimicrobial activity using a variety of conditions to offer the flexibility needed in test conditions to cover a broad range of microorganisms and test substances.
1.1.6 It is important to understand the limitations of in vitro tests, especially comparisons of results from tests performed with different parameters. As an example, test results of microorganisms requiring growth supplements or special incubation conditions may not be directly comparable to organisms evaluated without those stated conditions.
1.2 Knowledge of microbiological techniques is required for this procedure.
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, 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.

Guide
5 pages
English language
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Guide
5 pages
English language
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31-Mar-2023
07.100.99
E35

ASTM D6329-98(2023)(Guide)

Standard Guide for Developing Methodology for Evaluating the Ability of Indoor Materials to Support Microbial Growth Using Static Environmental Chambers

SIGNIFICANCE AND USE
4.1 The static chambers have several different applications:
4.1.1 The static chambers can be used to compare the susceptibility of different materials to the colonization and amplification of various microorganisms under defined conditions.
4.1.2 Chambers operated at high relative humidities may be used to perform worst case scenario screening tests on materials by providing an atmosphere where environmental conditions may be favorable for microbial growth.
4.1.3 Use of multiple chambers with different environmental parameters, such as a range of relative humidities, permits the evaluation of multiple microenvironments and allows investigation of materials under differing environmental conditions.
4.1.4 Drying requirements for wetted materials may also be investigated. This information may be relevant for determining material resistance to microbial growth after becoming wet. These conditions may simulate those where materials are subjected to water incursion through leaks as well as during remediation of a building after a fire.
4.1.5 Growth rates of microorganisms on the material may also be investigated. Once it has been established that organisms are able to grow on a particular material under defined conditions, investigations into the rate of organism growth may be performed. These evaluations provide base line information and can be used to evaluate methods to limit or contain amplification of microorganisms.
4.2 These techniques should be performed by personnel with training in microbiology. The individual must be competent in the use of sterile technique, which is critical to exclude external contamination of materials.
SCOPE
1.1 Many different types of microorganisms (for example, bacteria, fungi, viruses, algae) can occupy indoor spaces. Materials that support microbial growth are potential indoor sources of biocontaminants (for example, spores and toxins) that can become airborne indoor biopollutants. This guide describes a simple, relatively cost effective approach to evaluating the ability of a variety of materials to support microbial growth using a small chamber method.
1.2 This guide is intended to assist groups in the development of specific test methods for a definite material or groups of materials.
1.3 Static chambers have certain limitations. Usually, only small samples of indoor materials can be evaluated. Care must be taken that these samples are representative of the materials being tested so that a true evaluation of the material is performed.
1.4 Static chambers provide controlled laboratory microenvironment conditions. These chambers are not intended to duplicate room conditions, and care must be taken when interpreting the results. Static chambers are not a substitute for dynamic chambers or field studies.
1.5 A variety of microorganisms, specifically bacteria and fungi, can be evaluated using these chambers. This guide is not intended to provide human health effect data. However, organisms of clinical interest, such as those described as potentially allergenic, may be studied using this approach.
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.

Guide
6 pages
English language
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31-Dec-2022
07.100.99
D22

ASTM E3371-22(Test Method)

Standard Test Method for Measuring the Ability of a Synthetic Polymeric Material to Resist Bacterial Adherence

SIGNIFICANCE AND USE
5.1 This method can be used to evaluate the effectiveness of incorporated or bound anti-adherent agents in synthetic polymeric materials and polymeric coatings intended to reduce the attachment of bacteria to the substrate surface.
5.2 The synthetic polymeric substrate surface may be tested repeatedly over time for assessment of persistent ability of a material to resist bacterial adherence.
5.3 This method is to quantify the degree of bacteria colonization of a surface to assess a materials ability to resist bacterial adherence because biofilm formation can contribute to material degradation and malfunction.
SCOPE
1.1 This method is designed to evaluate (quantitatively) the number of bacteria attached to the flat, two-dimensional surfaces of synthetic polymeric materials and polymeric coatings on various substrates that may or may not contain bound or incorporated anti-adherent agents. The method focuses on assessing the ability of the surface to reduce bacterial attachment. Other microorganisms such as yeast and fungal conidia may be tested using this method.
1.2 This test method quantitatively determines the differences in bacterial adherence seen between synthetic polymeric surfaces that allow bacterial adherence and those that do not, comparing the number of organisms recovered from the control surface to the number recovered from the test specimen surface after the contact time. Knowledge of microbiological techniques is required for these procedures.
1.3 This test method specifies proper methods for measuring the ability of a synthetic polymeric material to resist adherence against specified organism. Due to individual sensitivities, the result of one test organism might not be applicable for other organisms.
1.4 This test method is designed to measure the potential ability to resist bacterial adherence of a non-porous surface compared directly to a polyester control panel known to support bacterial adherence under specific testing conditions.
1.5 Antimicrobial treated non-porous surfaces may demonstrate ability to resist bacterial adherence in this method. This method does not purport to differentiate between anti-adherence and antimicrobial activity nor is it designed to reflect specific end-use or environmental conditions. Any product that demonstrates ability to resist bacterial adherence in this method should be measured for antimicrobial activity using a separate test technique such as Test Method E2180 or ISO 22196.
1.6 The method focuses on assessing the ability of synthetic polymeric materials and polymeric coatings on various substrates to reduce bacterial attachment. The specimen with absorbing or adhesive surfaces may be unable to be disinfected properly before testing, or may trap inoculated organism during recovery process and thus lead to a false result. This method does not apply to specimens with absorbent or adhesive surfaces.
1.7 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.
1.8 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.

Standard
7 pages
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30-Sep-2022
07.100.99
83.080.01
E35

Standard Practice for In vitro production of Clostridioides difficile Spores

ASTM E3011-22(Practice)

SIGNIFICANCE AND USE
5.1 This practice describes a procedure for producing spore suspensions of C. difficile ATCC 700792, C. difficile ATCC 43598, or C. difficile ATCC 43599. The spore suspensions may be used in antimicrobial efficacy testing, or other laboratory testing requiring C. difficile spores. A spore crop is considered acceptable if the titer is >8 log10 spores/mL, purity of 95 %, and is resistant to 2.5M HCl after 10 min of exposure.
SCOPE
1.1 This practice is designed to propagate spores of Clostridioides difficile using liver broth.
1.2 It is the responsibility of the user of this practice to determine whether Good Laboratory Practices are required and follow when appropriate.
1.3 This practice should only be performed by those trained in microbiological techniques.
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 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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3 pages
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Standard
3 pages
English language
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30-Sep-2022
07.100.99
E35

ASTM E3364-22(Test Method)

Standard Test Method for Evaluating the Performance of Antimicrobials in or on Polymeric Porous and Nonporous Materials Against Staining by Streptomyces species (A Pink Stain Organism)

SIGNIFICANCE AND USE
5.1 Methods such as D3273 Standard Test Method for Resistance to Growth of Mold on the Surface of Interior Coatings in an Environmental Chamber and D3274 Standard Test Method for Evaluating the Degree of Surface Disfigurement of Paint Films by Fungal or Algal Growth or Soil or Dirt Accumulation provide means for assessing mold and algal staining on paints. The Test Method E1428 Evaluating the Performance of Antimicrobials in or on Polymeric Solids Against Staining by Streptomyces species (A Pink Stain Organism) is used for solid polymeric materials, but is not appropriate for all antimicrobial technologies.
5.2 This test method provides a technique for evaluating antimicrobials in or on polymeric materials against staining by Streptomyces species and should assist in the prediction of performance of treated articles under actual field conditions.
SCOPE
1.1 This test method is intended to assess susceptibility of polymer materials, as well as products that may directly contact the treated polymer, to staining by the Actinomycete Streptomyces species.
1.2 This test method is also suitable for evaluating dark-pigmented test samples since the bacterial growth inhibition can be assessed.
1.3 Familiarity with microbiological techniques is required. This test method should not be used by persons without at least basic microbiological training.
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.

Standard
4 pages
English language
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30-Sep-2022
07.100.99
E35

Standard Guide for Conducting Terrestrial Plant Toxicity Tests

ASTM E1963-22(Guide)

SIGNIFICANCE AND USE
5.1 Terrestrial phytotoxicity tests are useful in assessing the effects of environmental samples or specific chemicals as a part of an ecological risk assessment (3-6, 12, 13).
5.2 Though inferences regarding higher-order ecological effects (population, community, or landscape) may be made from the results, these tests evaluate responses of individuals of one or more plant species to the test substance.
5.3 This guide is applicable for: (a) establishing phytotoxicity of organic and inorganic substances; (b) determining the phytotoxicity of environmental samples; (c) determining the phytotoxicity of sludges and hazardous wastes, (d) assessing the impact of discharge of toxicants to land, and (e) assessing the effectiveness of remediation efforts.
SCOPE
1.1 This guide covers practices for conducting plant toxicity tests using terrestrial plant species to determine effects of test substances on plant growth and development. Specific test procedures are presented in accompanying annexes.
1.2 Terrestrial plants are vital components of ecological landscapes. The populations and communities of plants influence the distribution and abundance of wildlife. Obviously, plants are the central focus of agriculture, forestry, and rangelands. Toxicity tests conducted under the guidelines and annexes presented herein can provide critical information regarding the effects of chemicals on the establishment and maintenance of terrestrial plant communities.
1.3 Toxic substances that prevent or reduce seed germination can have immediate and large impacts to crops. In natural systems, many desired species may be sensitive, while other species are tolerant. Such selective pressure can result in changes in species diversity, population dynamics, and community structure that may be considered undesirable. Similarly, toxic substances may impair the growth and development of seedlings resulting in decreased plant populations, decreased competitive abilities, reduced reproductive capacity, and lowered crop yield. For the purposes of this guide, test substances include pesticides, industrial chemicals, sludges, metals or metalloids, and hazardous wastes that could be added to soil. It also includes environmental samples that may have had any of these test substances incorporated into soil.
1.4 Terrestrial plants range from annuals, capable of completing a life-cycle in as little as a few weeks, to long-lived perennials that grow and reproduce for several hundreds of years. Procedures to evaluate chemical effects on plants range from short-term measures of physiological responses (for example, chlorophyll fluorescence) to field studies of trees over several years. Research and development of standardized plant tests have emphasized three categories of tests: (1) short-term, physiological endpoints (that is, biomarkers); (2) short-term tests conducted during the early stages of plant growth with several endpoints related to survival, growth, and development; and (3) life-cycle toxicity tests that emphasize reproductive success.
1.5 This guide is arranged by sections as follows:
Section
Title
1
Scope
2
Referenced Documents
3
Terminology
4
Summary of Phytotoxicity Tests
5
Significance and Use
6
Apparatus
7
Test Material
8
Hazards
9
Test Organisms
10
Sample Handling and Storage
11
Calibration and Standardization
12
Test Conditions
13
Interference and Limitations
14
Quality Assurance and Quality Control
15
Calculations and Interpretation of Results
16
Precision and Bias
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 saf...

Guide
21 pages
English language
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Guide
21 pages
English language
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31-Jul-2022
07.100.99
E50

Pulp, paper and board - Microbiological examination - Part 3: Enumeration of yeast and mould based on disintegration

ISO 8784-3:2022(Main)

This document specifies a method for determining the total number of colony-forming units of yeast and mould in dry market pulp, paper and paperboard after disintegration. The enumeration relates to specific media.

Standard
9 pages
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Standard
9 pages
French language
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Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using ex vivo Porcine Skin

ASTM E2897-22(Guide)

SIGNIFICANCE AND USE
5.1 The guide may be used to demonstrate the effectiveness of topical antimicrobial products using pigskin as a surrogate for human skin and the cup scrub technique for sampling.
5.2 The techniques described can be used to simulate Test Method E1174 and will use the pigskin substrate to overcome limitations posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test tubes.
5.3 Use of the pigskin surrogate offers less expensive and higher throughput screening.
SCOPE
1.1 This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a surrogate model.
1.2 Knowledge of microbiological techniques is required for these procedures.
1.3 This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations.
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.

Guide
4 pages
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Guide
4 pages
English language
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31-Mar-2022
07.100.99
71.100.35
E35

ASTM E3285-22(Test Method)

Standard Test Method for Evaluation of Contact-Mediated Microbial Transference

SIGNIFICANCE AND USE
4.1 This test method utilizes filter paper as a medium for evaluating touch-transfer of bacteria to material surfaces. Sample surfaces are exposed to filter papers saturated with a Staphylococcus aureus suspension, followed by recovery of the bacteria from the surface with Replicate Organism Detection and Counting (RODAC) plates. This test method reports the log10 reduction of bacterial transfer on an intended test surface compared to a control surface. The test and control surfaces can differ by texture, coating, treatment, or any other desired variables, as long as they are the same material.
SCOPE
1.1 This test method is designed to evaluate the contact-mediated microbial transference on two-dimensional material surfaces. Material surfaces intended to reduce microorganism adherence or contamination may be evaluated using this test method. Additionally, this test method can be utilized on a wide variety of material surfaces for other downstream processes.
1.2 This test method is designed to quantify the fomite transfer of bacteria on material surfaces through touch-transfer, be inexpensive, require limited training in practice, and be adaptable to many surfaces or microorganisms. Non-porous surfaces are contaminated with inoculated filter paper as a carrier and surface contamination is quantified by sampling with Replicate Organism Detection and Counting (RODAC) plates.
1.3 Basic microbiology training is required to perform this test method.
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.

Standard
5 pages
English language
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14-Mar-2022
07.100.99
E35

Textiles - Determination of antibacterial activity of textile products (ISO 20743:2021)

EN ISO 20743:2021(Main)

SIST EN ISO 20743:2021

This document specifies quantitative test methods to determine the antibacterial activity of all antibacterial textile products including nonwovens.
This document is applicable to all textile products, including cloth, wadding, thread and material for clothing, bedclothes, home furnishings and miscellaneous goods, regardless of the type of antibacterial agent used (organic, inorganic, natural or man-made) or the method of application (built-in, after-treatment or grafting).
This document covers three inoculation methods for the determination of antibacterial activity:
a) absorption method (an evaluation method in which the test bacterial suspension is inoculated directly onto specimens);
b) transfer method (an evaluation method in which test bacteria are placed on an agar plate and transferred onto specimens);
c) printing method (an evaluation method in which test bacteria are placed on a filter and printed onto specimens).
NOTE Based on the intended application and on the environment in which the textile product is to be used, and also on the surface properties of the textile properties, the user can select the most suitable inoculation method.
This document also specifies the colony plate count method and the adenosine triphosphate (ATP) luminescence method for measuring the enumeration of bacteria.

Standard
41 pages
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22-Jun-2021
30-Dec-2021
07.100.99
59.080.01
CEN/TC 248

Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity

SIST EN 12353:2022(Main)

EN 12353:2021

This document specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this document is established.
NOTE 1   Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.
NOTE 2   European Standards (EN) where this document is referenced are listed in the Bibliography.
NOTE 3   A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.

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KDS

Standard Practice for Collection of Fungal Material from Surfaces by Swab

ASTM D7789-21(Practice)

SIGNIFICANCE AND USE
4.1 This practice provides a procedure for collecting surface material using a sterile swab.
4.2 A swab sample collected according to this practice is intended to be used to assess fungal material on surfaces.
4.3 A swab sample collected from an area with defined dimensions can be used to quantify fungal material per unit area or for qualitative analysis.
4.4 A swab sample collected from point(s) of interest can be used for qualitative analysis or to quantify fungal material per sample.
4.5 A swab sample collected according to this practice can be analyzed by direct microscopy, culture, or biochemical analysis.
SCOPE
1.1 The purpose of this practice is to describe the procedures for collection of surface samples using sterile swabs.
1.2 The purpose of this practice is to support the field investigator in differentiating fungal materials from non-fungal material such as scuffs, soot deposits, stains, pigments, dust, efflorescence, adhesives, dust, and water stains.
1.3 This practice does not address building occupant exposures, or occupant health risks.
1.4 The samples collected by this practice are appropriate for culture, direct microscopy, and biochemical analysis, or combination thereof.
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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D22

Standard Practice for Determination of Endotoxin Concentrations in Water-Miscible Metalworking Fluids

ASTM E2657-21(Practice)

SIGNIFICANCE AND USE
5.1 The determination of endotoxin concentrations in MWF is a parameter that can be used in decision-making for prudent fluid management practices (fluid draining, cleaning, recharging, or biocide dosages).
5.2 This standard provides a practice for analysts who perform quantitative endotoxin analyses of water-miscible MWF.
SCOPE
1.1 This practice covers quantitative methods for the sampling and determination of bacterial endotoxin concentrations in water-miscible metalworking fluids (MWF).
1.2 Users of this practice need to be familiar with the handling of MWF.
1.3 This practice gives an estimate of the endotoxin concentration in the sampled MWF.
1.4 This practice replaces Method E2250.
1.5 This practice seeks to minimize interlaboratory variation of endotoxin data but does not ensure uniformity of results.
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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E34

Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method

ASTM F3504-21(Practice)

SIGNIFICANCE AND USE
5.1 In-vitro cell proliferation assays are used to screen the capability of cells to proliferate and self-renew within scaffolds for regenerative medicine and tissue-engineering applications. The cell proliferation in vitro, in conjunction with other characteristics of the cells such as gene expression, can be used to determine if the cells have maintained their properties.
5.2 Cell proliferation may be an important parameter to test as a quality attribute of a cell-scaffold construct. This test helps to assess cell colonization within a scaffold.
5.3 This method provides a technique for vital assessment and quantification of the fluorescence intensity related to dye metabolism by living and proliferating cells. This method assumes that viable cells will have an active metabolism, which is required to support life-associated cellular processes such as the conversion of nutrient sources into energy and proliferation. There may be cells that are not actively proliferating, yet are still viable within the construct. The methods described within this practice enable nondestructive testing for monitoring the cell proliferation kinetics throughout the culture period by repeated analysis at multiple time points on the same test sample with minimal toxicity. This standard practice is written only for resazurin dye, a non-cytotoxic reagent that should not affect cell viability and proliferation at low concentration. This is a distinct advantage over many other reagents used to measure cell number, such as measurements of the intracellular components (such as DNA, protease, or ATP) which require cell lysis and can therefore only be used for endpoint analysis.
5.4 Resazurin, which has low fluorescence, may be metabolized by cells into resorufin, which is highly fluorescent. An increase in fluorescence caused by the conversion to resorufin may correlate with increased dehydrogenase activity, which may correlate with an increase in cell number and therefore proliferatio...
SCOPE
1.1 This practice describes how to conduct a nondestructive proliferation test for mammalian cells based on metabolic activity that can be used to assess the number of viable cells within three-dimensional (3D) scaffolds for regenerative medicine and in tissue-engineered medical products (TEMPs).
1.2 This practice provides a detailed explanation of the resazurin cell metabolic activity method in terms of reagent concentrations, incubation times, cell culture media composition, calibration curve, controls, assay linearity, and limitations of the assay.
1.3 This practice describes factors that can interfere with accurate cell proliferation assessment.
1.4 Since the assay has washing steps, it is limited to assessing cells that are immobilized, such as by adhesion to a culture dish, adhesion to a scaffold, or encapsulation in a hydrogel.
1.5 The assay is limited to cell types that can metabolize resazurin to provide a signal in the assay.
1.6 This document does not propose acceptance criteria for a cell-based product based on the application of a cell proliferation test method.
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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F04

ASTM D7817-12(2021)(Test Method)

Standard Test Method for Enumeration of Yeast and Mold in Raceway Brine, Brine-Cured Hides and Skins

SIGNIFICANCE AND USE
4.1 This test method enumerates salt tolerant yeast and mold, and under the conditions of this test method those are equated as halophilic organisms. Salt tolerant yeast and mold have been known to cause damage to hides and skins in raceway brine.
SCOPE
1.1 This test method covers the enumeration of yeast and mold. This test method is applicable to raceway brine, brine-cured hides and skins, and pre-charge raceway liquor.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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D31

ASTM D7910-14(2021)(Practice)

Standard Practice for Collection of Fungal Material From Surfaces by Tape Lift

SIGNIFICANCE AND USE
4.1 This practice defines a consistent procedure for collecting surface material using clear, transparent, single sided adhesive collection medium, typically tape (also known as tape lift).
4.2 A tape lift sample collected according to this practice is intended to be used to assess the material present at one specific location on a surface for fungal content.
4.3 A tape lift sample collected from a point of interest can be used for qualitative analysis or to quantify fungal material per sample or per unit area. Note that the recovery efficiency of material from the surface sampled is unknown and a likely source of uncertainty for quantitative analyses.
4.4 A tape lift sample collected according to this practice can be analyzed by direct microscopy.
4.5 This practice may help supplement consistency in mold sampling during an indoor air quality investigation.
SCOPE
1.1 This practice describes the protocols for collection of surface samples using tape lifts and their delivery to the laboratory.
1.2 The purpose of this practice is to support the field investigator in differentiating fungal materials from non-fungal material such as scuffs, soot deposits, stains, pigments, dust, efflorescence, adhesives, and water stains.
1.3 The samples collected by this practice are appropriate for either qualitative or quantitative analysis by direct microscopy.
1.4 This practice does not address building occupant exposures, or occupant health risks.
1.5 This practice does not address the development of a formal hypothesis or the establishment of sampling objectives.
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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D22

ASTM D7819-12(2021)(Test Method)

Standard Test Method for Enumeration of Yeast and Mold on Fresh (Uncured) Hides and Skins

SIGNIFICANCE AND USE
4.1 This test method enumerates yeast and mold. Yeast and mold have been known to cause damage to hides and skins.
SCOPE
1.1 This test method covers the enumeration of yeast and mold on fresh (uncured) hides and skins. This test method is applicable to uncured hides and skins.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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D31

ASTM D7658-17(2021)(Test Method)

Standard Test Method for Direct Microscopy of Fungal Structures from Tape

SIGNIFICANCE AND USE
5.1 The significance of this test method is to standardize the analysis of the detection of removable fungal structures lifted from a surface with tape to improve consistency between laboratories and analysts.
5.2 This test method is intended to ensure consistent data to the end user.
5.3 Fungal structures are identified and semi-quantified regardless of whether they would or would not grow in culture.
5.4 It must be emphasized that the detector in this test method is the analyst, and therefore results are subjective, depending on the experience, training, qualification, optical acuity, and mental fatigue of the analyst.
5.5 This test method can be used to assess the presence and characteristics of fungal material on a surface.
SCOPE
1.1 This test method uses optical microscopy for the detection, semi-quantification, and identification of fungal structures in tape lift preparations.
1.2 This test method describes the preparation techniques for tape-lift matrices, the procedure for confirming the presence of fungal structures, and the reporting of observed fungal structures
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, 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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D22

SIST EN ISO 20743:2021(Main)

Textiles - Determination of antibacterial activity of textile products (ISO 20743:2021)

EN ISO 20743:2021

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ITEK

Textiles - Determination of antibacterial activity of textile products

ISO 20743:2021(Main)

This document specifies quantitative test methods to determine the antibacterial activity of all antibacterial textile products including nonwovens. This document is applicable to all textile products, including cloth, wadding, thread and material for clothing, bedclothes, home furnishings and miscellaneous goods, regardless of the type of antibacterial agent used (organic, inorganic, natural or man-made) or the method of application (built-in, after-treatment or grafting). This document covers three inoculation methods for the determination of antibacterial activity: a) absorption method (an evaluation method in which the test bacterial suspension is inoculated directly onto specimens); b) transfer method (an evaluation method in which test bacteria are placed on an agar plate and transferred onto specimens); c) printing method (an evaluation method in which test bacteria are placed on a filter and printed onto specimens). NOTE Based on the intended application and on the environment in which the textile product is to be used, and also on the surface properties of the textile properties, the user can select the most suitable inoculation method. This document also specifies the colony plate count method and the adenosine triphosphate (ATP) luminescence method for measuring the enumeration of bacteria.

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ASTM E3218-21(Test Method)

Standard Test Method for Quantitative Method for Testing Antimicrobial Agents against Spores of C. difficile on Hard, Nonporous Surfaces

SIGNIFICANCE AND USE
5.1 The test method was designed to determine the LR in spores on a hard, non-porous surface after exposure to a test chemical in a closed system.
5.2 Each test includes three control carriers (exposed to phosphate buffered saline with Tween-80), three test system control carriers (exposed to 1500 ppm ± 150 ppm sodium hypochlorite), and ten treated carriers (per test chemical/concentration/contact time combination).
SCOPE
1.1 This test method covers a standardized approach to quantitatively determine the effectiveness of antimicrobial chemicals in treating hard, non-porous surfaces contaminated with spores of C. difficile (ATCC 43598) grown in accordance with Practice E2839.
1.2 This test method is based on principles established for Test Method E2197 and an Organisation for Economic Co-operation and Development Guidance Document.2
1.3 Training in basic microbiology and aseptic technique are required to perform this assay.
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 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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E35

Standard Practice for Production and Storage of Spores of C. difficile for Use in Efficacy Evaluation of Antimicrobial Agents

ASTM E2839-21(Practice)

SIGNIFICANCE AND USE
5.1 This practice describes a procedure for preparing and storing a suspension of C. difficile spores that meets the following acceptance criteria: (1) spore titer of approximately 5.0×108 spores/mL, (2) spore purity of ≥95 %, and (3) a mean log10 reduction (LR) value >5.0 for 3 carriers exposed to 5000 ppm and a mean LR of E3218.
SCOPE
1.1 This practice specifies the procedures for producing and storing standardized suspensions of Clostridioides difficile spores for the evaluation of the sporicidal activity of antimicrobial formulations using the Quantitative Method for Testing Antimicrobial Agents against Spores of C. difficile on Hard, Non-porous Surfaces or other procedures.
1.2 This practice may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology.
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, 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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E35

Geosynthetics - Method for determining the microbiological resistance by a soil burial test

EN 12225:2020(Main)

SIST EN 12225:2021

This document specifies a method for the determination of the microbiological resistance of geosynthetics including those of natural fibres and biodegradable polymers by a soil burial test.
NOTE Experience and exhumation of geosynthetics which had performed successfully, in some cases for more than two decades, indicate that geosynthetics made out of synthetic materials are generally resistant against microbial initiated decay. It can therefore be expected that most of these products commercially available at the present time will pass the soil burial test successfully and it is probably not necessary to submit them all to this test independent of their function. However, if the requirements for appropriate functioning of the geosynthetics demand proof of microbiological resistance or if they are manufactured from newly developed polymers whose resistance is in any doubt, the soil burial test can provide additional information.

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305/2011
CEN/TC 189

ASTM D7463-21(Test Method)

Standard Test Method for Adenosine Triphosphate (ATP) Content of Microorganisms in Fuel, Fuel/Water Mixtures, and Fuel Associated Water

SIGNIFICANCE AND USE
5.1 This test method measures the concentration of ATP present in the sample. ATP is a constituent of all living cells including bacteria and fungi. Consequently, the presence of ATP is a reliable indicator of microbial contamination in fuel systems. ATP is not associated with matter of non-biological origin.
5.2 This test method differs from Test Method D4012 as follows:
5.2.1 By providing for the rapid determination of ATP present in a fuel (petroleum) sample, a fuel and water mixture sample, fuel-associated bottom water sample, and extracellular ATP freely available in the fuel or aqueous sample matrix;
5.2.2 By providing for a method to capture, extract, and quantify ATP using self-contained test device and luminometer;
5.2.3 By providing a method of quantifying ATP present in fuel or water matrices in generally less than 10 min; and
5.2.4 By providing for the rapid separation of the ATP from chemical interferences that have previously prevented the use of ATP determinations in complex fluids containing hydrocarbons and other organic molecules.
5.3 This test method does not require the use of hazardous materials and does not generate biohazard waste.
5.4 This test method can be used to estimate viable microbial biomass, to evaluate the efficacy of antimicrobial pesticides, and to monitor microbial contamination in fuel storage and distribution systems.
SCOPE
1.1 This test method provides a protocol for capturing, concentrating, and testing the adenosine triphosphate (ATP) present in a fuel system sub-sample (that is, test specimen) associated with:
1.1.1 Microorganisms and hydrophilic particles found in liquid fuels as described in Table X6.1, or
1.1.2 Microorganisms and hydrophilic particles found in mixture of fuel and associated bottom water or just associated bottom water.
1.1.3 ATP detected by this bioluminescence test can be derived from cellular ATP, extra-cellular ATP, or some combination of both.
1.1.4 Cellular and extra-cellular ATP utilized to perform ATP bioluminescence are captured and concentrated from a fuel system sample into an aqueous test specimen (that is, sub-sample) for testing. For example, for a fuel system sample that does not contain any visible fuel associated bottom water, the aqueous test specimen is the capture solution itself described in 8.2.1.1. For fuel system samples that are a mixture of fuel and associated bottom water (that is, free water), the test specimen is an aliquant of the capture solution and associated bottom water.
1.2 The ATP is measured using a patented bioluminescence enzyme assay, whereby light is generated in amounts proportional to the concentration of ATP in the sample. The light is produced and measured quantitatively using dedicated ATP test pens2 and a dedicated luminometer2 and reported in (instrument specific) Relative Light Units.
1.3 This test method is equally suitable for use in the laboratory or field.
1.4 Although bioluminescence is a reliable and proven technology, this method does not differentiate ATP from bacteria or fungi.
1.5 For water or capture solution samples, the concentration range of ATP detectable by this test method is 1 × 10–11  M to 3 × 10–8  M which is equivalent to 1 × 10–14  moles/mL to 3 × 10–11  moles/mL for water samples or capture solution. Assuming testing on fuel phase is performed on a 500 mL volume of fuel the equivalent concentrations is fuel would be: 6 × 10–11 M to 2 × 10–14 M.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6.1 There is one exception—Relative Light Unit (RLU) as defined in 3.1.19.
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 r...

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D02

Geosynthetics - Method for determining the microbiological resistance by a soil burial test

SIST EN 12225:2021(Main)

EN 12225:2020

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305/2011
ITEK

Standard Practice for Manual Sampling of Liquid Fuels, Associated Materials and Fuel System Components for Microbiological Testing

ASTM D7464-20(Practice)

SIGNIFICANCE AND USE
5.1 Representative samples of fuel products and associated substances are required for the determination of microbial contamination in fuels and fuel systems in order to accurately assess the biodeterioration risk posed to the fuel, fuel-system components or both. Uncontrolled microbial contamination can affect fuel specification properties adversely.6 As discussed in Guide D6469, microbes can cause a variety of operational problems, including filter plugging and microbially influenced corrosion (MIC), the latter of which causes valve failure, tank and pipeline failure.
5.2 These practices for microbiological sampling decrease the risk of contaminating samples with extraneous microbes, thereby increasing the probability that the original microbial population in the sample does not change significantly between the time of sampling and the time of testing.
5.3 The objective of sampling for microbiological testing is to obtain representative samples that are likely to reflect the degree and nature of microbial contamination in the system from which the samples are collected. Manual 477 addresses the rationale for and design of microbial contamination programs. Recognizing that microbiological contamination is not distributed uniformly throughout fuel systems, both the number and types of samples collected will normally be different from the samples collected per Practice D4057 in order to determine whether product meets specifications.
5.4 The physical, chemical and microbiological property tests to be performed on a sample will dictate the sampling procedures, the sample quantity required, and many of the sample handling requirements.
5.5 Fuel systems are not normally designed to facilitate optimal microbiological sampling. Consequently, the selection of sampling device and sample source reflect compromises between accessibility and suitability for meeting the sample collection objective.
5.6 The guidance provided in Practice D4057 generally applies to ...
SCOPE
1.1 This practice covers aspects of sample device preparation and sample handling that prevent samples from becoming contaminated with microorganisms not originally contained within the sample.
1.2 This practice also covers sample handling considerations that reflect the perishability of samples collected for microbiological testing.
1.3 This practice supplements Practice D4057 by providing guidance specific to the manual sampling of fuels when samples are to be tested for microbial contamination.
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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D02

Workplace exposure - Measurement of airborne microorganisms and microbial compounds - General requirements

EN 13098:2019(Main)

SIST EN 13098:2019

This document specifies general requirements for the measurement of microorganisms and microbial compounds.
This document provides also guidelines for the assessment of workplace exposure to airborne microorganisms including the determination of total number and culturable number of microorganisms and microbial compounds in the workplace atmosphere.
This document does not apply to the measurement of viruses.

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13.040.30
CEN/TC 137

ASTM D7391-20(Test Method)

Standard Test Method for Categorization and Quantification of Airborne Fungal Structures in an Inertial Impaction Sample by Optical Microscopy

SIGNIFICANCE AND USE
5.1 This test method is used to estimate and categorize the number and type of fungal structures present on an inertial impactor sample.
5.2 Fungal structures are identified and quantified regardless of whether they would or would not grow in culture.
5.3 It must be emphasized that the detector in this test method is the analyst, and therefore results are subjective, depending on the experience, training, qualification, and mental and optical fatigue of the analyst.
SCOPE
1.1 This test method is a procedure that uses direct microscopy to analyze the deposit on an inertial impaction sample.
1.2 This test method describes procedures for categorizing and enumerating fungal structures by morphological type. Typically, categories may be as small as genus (for example, Cladosporium) or as large as phylum (for example, basidiospores).
1.3 This test method contains two procedures for enumerating fungal structures: one for slit impaction samples and one for circular impaction samples. This test method is applicable for impaction air samples, for which a known volume of air (at a rate as recommended by the manufacturer) has been drawn, and is also applicable for blank impaction samples.
1.4 Enumeration results are presented in fungal structures/sample (fs/sample) and fungal structures/m3 (fs/m3).
1.5 The range of enumeration results that can be determined with this test method depends on the size of the spores on the sample trace, the amount of particulate matter on the sample trace, the percentage of the sample trace counted, and the volume of air sampled.
1.6 This test method addresses only the analysis of samples. The sampling process and interpretation of results is outside the scope of this test method.
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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D22

Plastics - Evaluation of the action of microorganisms (ISO 846:2019)

EN ISO 846:2019(Main)

SIST EN ISO 846:2019

This document specifies methods for determining the deterioration of plastics due to the action of fungi and bacteria and soil microorganisms. The aim is not to determine the biodegradability of plastics or the deterioration of natural fibre composites.
The type and extent of deterioration can be determined by
a)    visual examination and/or
b)    changes in mass and/or
c)    changes in other physical properties.
The tests are applicable to all plastics that have an even surface and that can thus be easily cleaned. The exceptions are porous materials, such as plastic foams.
This document uses the same test fungi as IEC 60068-2-10. The IEC method, which uses so-called "assembled specimens", calls for inoculation of the specimens with a spore suspension, incubation of the inoculated specimens and assessment of the fungal growth as well as any physical attack on the specimens.
The volume of testing and the test strains used depend on the application envisaged for the plastic.

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CEN/TC 249

Workplace exposure - Measurement of airborne microorganisms and microbial compounds - General requirements

SIST EN 13098:2019(Main)

EN 13098:2019

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KAZ

Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds

ASTM F2739-19(Guide)

SIGNIFICANCE AND USE
5.1 The number and distribution of viable and non-viable cells within, or on the surface of, a biomaterial scaffold is one of several important characteristics that may determine in vivo product performance of cell/biomaterial constructs (see 5.7); therefore, there is a need for standardized test methods to quantify cell viability.
5.2 There are a variety of static and dynamic methods to seed cells on scaffolds, each with different cell seeding efficiencies. In general, static methods such as direct pipetting of cells onto scaffold surfaces have been shown to have lower cell seeding efficiencies than dynamic methods that push cells into the scaffold interior. Dynamic methods include: injection of cells into the scaffold, cell seeding on biomaterials contained in spinner flasks or perfusion chambers, or seeding that is enhanced by the application of centrifugal forces. The methods described in this guide can assist in establishing cell seeding efficiencies as a function of seeding method and for standardizing viable cell numbers within a given methodology.
5.3 As described in Guide F2315, thick scaffolds or scaffolds highly loaded with cells lead to diffusion limitations during culture or implantation that can result in cell death in the center of the construct, leaving only an outer rim of viable cells. Spatial variations of viable cells such as this may be quantified using the tests within this guide. The effectiveness of the culturing method or bioreactor conditions on the viability of the cells throughout the scaffold can also be evaluated with the methods described in this guide.
5.4 These test methods can be used to quantify cells on non-porous or within porous hard or soft 3-D synthetic or natural-based biomaterials, such as ceramics, polymers, hydrogels, and decellularized extracellular matrices. The test methods also apply to cells seeded on porous coatings.
5.5 Test methods described in this guide may also be used to distinguish between prolifer...
SCOPE
1.1 This guide is a resource of cell viability test methods that can be used to assess the number and distribution of viable and non-viable cells within porous and non-porous, hard or soft biomaterial scaffolds, such as those used in tissue-engineered medical products (TEMPs).
1.2 In addition to providing a compendium of available techniques, this guide describes materials-specific interactions with the cell assays that can interfere with accurate cell viability analysis, and includes guidance on how to avoid or account for, or both, scaffold material/cell viability assay interactions.
1.3 These methods can be used for 3-D scaffolds containing cells that have been cultured in vitro or for scaffold/cell constructs that are retrieved after implantation in living organisms.
1.4 This guide does not propose acceptance criteria based on the application of cell viability test methods.
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.

Guide
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Guide
8 pages
English language
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F04

SIST EN ISO 846:2019(Main)

Plastics - Evaluation of the action of microorganisms (ISO 846:2019)

EN ISO 846:2019

Standard
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IPMA

Standard Practice for Producing High Titers of Viable and Semi-Purified Spores of Clostridium difficile using a Liquid Medium

ASTM E2895-19(Practice)

SIGNIFICANCE AND USE
5.1 The quantity and quality of the spores produced by this practice may be used to assess environmental surface disinfectants for sporicidal activity (4). The method is applicable to standard as well as clinically isolated toxigenic and non-toxigenic strains of C. difficile.
SCOPE
1.1 This practice describes the production and semipurification of C. difficile spores (also called endospores) primarily for use in testing the sporicidal activities of environmental surface disinfectants (Test Methods E2111and E2197); such spores can also be used to study their structure, chemistry and germination.
1.2 While the practice described is based on the use of 500-mL volumes of the liquid culture medium in an anaerobic incubator, anaerobic jars with smaller volumes of the same medium can also be used.
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practice (GLP) regulations are required and to follow them when appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR; Part 58 for FDA submissions).
1.4 Warning—This standard may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard
6 pages
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Standard
6 pages
English language
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31-Mar-2019
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E35

Standard Practice for Collection of Culturable Airborne Fungi or Bacteria on Agar Plates by Inertial Impaction Systems

ASTM D8068-19(Practice)

SIGNIFICANCE AND USE
4.1 This practice is intended for the collection of airborne particles on agar plates using inertial impaction for the purpose of culturing fungi or bacteria.
4.2 This practice is valuable when species level identification or quantity of culturable aerosolized fungi and bacteria are important factors for the indoor air quality investigation.
4.3 It is the responsibility of the user to assure that they are in compliance with all local, state, and federal regulations governing the inspection of buildings for fungal and bacterial colonization and the collection of associated samples.
4.4 This practice is intended to provide the user with a basic understanding of the equipment, materials, and instructions necessary to effectively collect air samples on agar plates using an inertial impactor.
4.5 This practice is intended to minimize systematic sampling variations between different data sets.
SCOPE
1.1 The purpose of this practice is to describe procedures for the collection of culturable airborne fungal spores or fragments or bacteria on agar plates using inertial impaction sampling techniques.
1.2 This practice does not include collection of culturable fungi or bacteria by devices not using agar plates.
1.3 This practice presumes that the user has a fundamental understanding of field investigative techniques related to the scientific process, and sampling plan development and implementation. It is important to establish the related hypothesis to be tested and the supporting analytical methodology needed in order to identify the sampling media to be used and the laboratory conditions for analysis.
1.4 This practice does not address the development of a formal hypothesis or the establishment of appropriate and defensible investigation and sampling objectives. It is presumed the investigator has the experience and knowledge base to address these issues.
1.5 This practice does not provide the user sufficient information to allow for interpretation of the analytical results from sample collection. It is the user's responsibility to seek or obtain the information and knowledge necessary to interpret the sample results reported by the laboratory.
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.

Standard
4 pages
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Standard
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28-Feb-2019
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D22

Plastics - Evaluation of the action of microorganisms

ISO 846:2019(Main)

This document specifies methods for determining the deterioration of plastics due to the action of fungi and bacteria and soil microorganisms. The aim is not to determine the biodegradability of plastics or the deterioration of natural fibre composites. The type and extent of deterioration can be determined by a) visual examination and/or b) changes in mass and/or c) changes in other physical properties. The tests are applicable to all plastics that have an even surface and that can thus be easily cleaned. The exceptions are porous materials, such as plastic foams. This document uses the same test fungi as IEC 60068-2-10. The IEC method, which uses so-called "assembled specimens", calls for inoculation of the specimens with a spore suspension, incubation of the inoculated specimens and assessment of the fungal growth as well as any physical attack on the specimens. The volume of testing and the test strains used depend on the application envisaged for the plastic.

Standard
26 pages
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Standard
27 pages
French language
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Surface active agents - Microbiology - Microbiological test methods for liquid hand dishwashing

ISO 21703:2019(Main)

This document provides microbiological test methods for enumeration and detection of aerobic mesophilic bacteria, detection of Escherichia coli and Pseudomonas aeruginosa in liquid hand dishwashing.

Standard
19 pages
English language
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Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017)

EN ISO 16212:2017(Main)

SIST EN ISO 16212:2017

ISO 16212:2017 gives general guidelines for enumeration of yeast and mould present in cosmetics by counting the colonies on selective agar medium after aerobic incubation.
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic products to which ISO 16212:2017 is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity or extreme pH values, hydro-alcoholic products, etc.
Because of the large variety of cosmetic products within this field of application, this method might not be suited to some products in every detail (e.g. certain water-immiscible products). Other methods (e.g. automated) can be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
Yeast enumerated can be identified using suitable identification tests, for example, tests described in the standards listed in the Bibliography. Mould enumerated can be identified by other appropriate methods, if necessary.

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CEN/TC 392

Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017)

EN ISO 21148:2017(Main)

SIST EN ISO 21148:2017

ISO 21148:2017 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).

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M/426
CEN/TC 392

Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017)

EN ISO 18415:2017(Main)

SIST EN ISO 18415:2017

ISO 18415:2017 gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products.
Microorganisms considered as specified in this document might differ from country to country according to national practices or regulations. Most of them considered as specified microorganisms include one or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans.
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic products to which this document is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity, hydro-alcoholic products, extreme pH values, etc.
The method described in this document is based on the detection of microbial growth in a non-selective liquid medium (enrichment broth) suitable to detect microbial contamination, followed by isolation of microorganisms on non-selective agar media. Other methods can be appropriate depending on the level of detection required.
In ISO 18415:2017 specific indications are given for identification of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans. Other microorganisms that grow under the conditions described in this document may be identified by using suitable tests according to a general scheme (see Annex A). Other standards (e.g. ISO 18416, ISO 21150, ISO 22717, ISO 22718) may be appropriate.
Because of the large variety of cosmetic products within this field of application, this method might not be suited in every detail to some products (e.g. certain water-immiscible products). Other methods (e.g. automated) can be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.

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CEN/TC 392

Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2017)

EN ISO 21149:2017(Main)

SIST EN ISO 21149:2017

ISO 21149:2017 gives general guidelines for enumeration and detection of aerobic mesophilic bacteria present in cosmetics
- by counting the colonies on agar medium after aerobic incubation, or
- by checking the absence of bacterial growth after enrichment.
Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
If needed, microorganisms enumerated or detected may be identified using suitable identification tests described in the standards given in the Bibliography.
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic products to which this document is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity, hydro-alcoholic products, extreme pH values, etc.

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M/426
CEN/TC 392

Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2017)

EN ISO 29621:2017(Main)

SIST EN ISO 29621:2017

ISO 29621:2017 gives guidance to cosmetic manufacturers and regulatory bodies to help define those finished products that, based on a risk assessment, present a low risk of microbial contamination during production and/or intended use, and therefore, do not require the application of microbiological International Standards for cosmetics.

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CEN/TC 392

ASTM E2800-11(2017)(Practice)

Standard Practice for Characterization of Bacillus Spore Suspensions for Reference Materials

SIGNIFICANCE AND USE
5.1 Standard practices for the characterization of spores used as reference materials are important to ensure a uniform basis for testing the performance of detection devices and laboratory instruments. Bacillus spore suspensions can be used for a large variety of purposes including testing environmental sampling techniques, inactivation methods, decontamination methods and basic research.
5.2 The practice is intended for both manufacturers and end users of Bacillus spore suspensions. The results of the characterization measurements are presented in a report of analysis (ROA). The ROA should provide sufficient detail about the measurement technique to enable the customers to replicate the measurements, allowing them to determine if the properties of the spore suspension changed during shipping and storage.
5.3 The enumeration of the viable spores and determination of homogeneity by microscopic analysis are two basic measurements required for the minimal characterization of reference materials. Phase contrast microscopy does not require staining to distinguish the “phase bright” dormant spores from phase dark spores, dark vegetative cells and clumps. When spores germinate they appear phase dark under phase contrast imaging (5). Germinated spores in a reference sample will soon die due to lack of nutrients. It is important in storing samples to prevent the premature germination of the spores. This standard practice includes the important steps for these measurements and includes guidance for advanced measurements. Additional guidance is given for advanced techniques to characterize spore suspensions that may be used to provide a higher level of characterized Bacillus  spore reference samples.
5.4 The specific properties of the spores used for their intended application, such as susceptibility to disinfectant processes, should be determined in addition to the basic measurements covered in this practice. Additional information on the measurement of spore proper...
SCOPE
1.1 This practice is focused on two basic measurements to characterize Bacillus reference materials, the enumeration of spores using growth of colonies on nutrient media and using phase contrast microscopy to determine spore quality and homogeneity. Additional information on advanced methods for characterization is provided in Appendix X1.
1.2 This document will provide the user with recommendations for measurement methods, and the details and conditions that should be employed to ensure reliable and high-quality data are obtained. The practice will help ensure that results obtained from the characterization are reported in a uniform manner. This will allow others to replicate the measurements and facilitate the comparison of different lots of Bacillus spore suspensions used as reference materials. It is important to note that the Bacillus species are a heterogeneous group and their specific requirements for growth and sporulation may vary. Users of this practice are encouraged to consult the literature for specific information on the species of Bacillus bacteria they are using (1).2
1.3 This standard practice does not provide guidance for the identification of unknown species of bacteria. The identification of Bacillus species has been traditionally based on colony morphology, growth on selective media, and biochemical tests, but more recently nucleic acid technologies have enabled the phylogenetic analysis of this group based on 16S DNA sequence similarities (1).
1.4 Some Bacillus spp. are pathogenic to humans and animals and the user is advised to adhere to safe laboratory procedures and practices for handling spores from these species (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...

Standard
8 pages
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31-Aug-2017
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E54