07.100.01 - Microbiology in general
ICS 07.100.01 Details
Microbiology in general
Mikrobiologie im allgemeinen
Microbiologie en général
Mikrobiologija na splošno
General Information
Frequently Asked Questions
ICS 07.100.01 is a classification code in the International Classification for Standards (ICS) system. It covers "Microbiology in general". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 176 standards classified under ICS 07.100.01 (Microbiology in general). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.
- Standard43 pagesEnglish languagee-Library read for1 day
This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of EN 12469.
- Standard24 pagesEnglish languagee-Library read for1 day
This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies the minimum requirements for BSC with respect to design, construction, safety and hygiene and gives general test methods for their verification.
The requirements for the different classes are given in the respective parts of prEN 12469.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies the specific requirements for class II BSC with respect to design, construction, safety and hygiene.
It sets the specific performance criteria for class II BSC for work with biological agents and specifies test procedures with respect to protection of the worker, the environment and product protection including cross-contamination.
- Standard43 pagesEnglish languagee-Library read for1 day
This document defines the requirements for competence of individuals who provide advice, guidance, and assurance on processes to identify, assess, control, and monitor the risks associated with hazardous biological materials in a laboratory or other related organization that handles, stores, transports, or disposes of biological materials that can be potentially hazardous for people, animals, plants and the environment.
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SIGNIFICANCE AND USE
4.1 This practice provides uniform guidance for cleaning the laboratory glassware, plasticware, and equipment used in routine microbiological analyses. However, tests that are extremely sensitive to toxic agents (such as virus assays) may require more stringent cleaning practices.2
SCOPE
1.1 In microbiology, clean glassware is crucial to ensure valid results. Previously used or new glassware must be thoroughly cleaned. Laboratory ware and equipment that are not chemically clean are responsible for considerable losses in personnel time and supplies in many laboratories. These losses may occur as down time when experiments clearly have been adversely affected and as invalid data that are often attributed to experimental error. Chemical contaminants that adversely affect experimental results are not always easily detected. This practice describes the procedures for producing chemically clean glassware.
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. For specific precautions, see Section 6, 5.7.3.1, and 8.3.1.
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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SIGNIFICANCE AND USE
5.1 This method can be used to evaluate effectiveness of incorporated/bound antimicrobials in hydrophobic materials such as plastics, epoxy resins, as well as other hard surfaces.
5.2 The aqueous based bacterial inoculum remains in close, uniform contact in a “pseudo-biofilm” state with the treated material. The percent reduction in the surviving populations of challenge bacterial cells at 24 h versus those recovered from a non-treated control is determined.
5.3 The hydrophobic substrate may be repeatedly tested over time for assessment of persistent antimicrobial activity.
SCOPE
1.1 This test method is designed to evaluate (quantitatively) the antimicrobial effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces. The method focuses primarily on assessing antibacterial activity; however, other microorganisms such as yeast and fungal conidia may be tested using this method.
1.2 The vehicle for the inoculum is an agar slurry which reduces the surface tension of the saline inoculum carrier and allows formation of a “pseudo-biofilm,” providing more even contact of the inoculum with the test surface.
Note 1: This test method facilitates the testing of hydrophobic surfaces by utilizing cells held in an agar slurry matrix. This test method, as written, is inappropriate to determine efficacy against biofilm cells, which are different both genetically and metabolically than planktonic cells used in this test.
1.3 This method can confirm the presence of antimicrobial activity in plastics or hydrophobic surfaces and allows determination of quantitative differences in antimicrobial activity between untreated plastics or polymers and those with bound or incorporated low water-soluble antimicrobial agents. Comparisons between the numbers of survivors on preservative-treated and control hydrophobic surfaces may also be made.
1.4 The procedure also permits determination of “shelf-life” or long term durability of an antimicrobial treatment which may be achieved through testing both non-washed and washed samples over a time span.
1.5 Knowledge of microbiological techniques is required for these procedures.
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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SIGNIFICANCE AND USE
3.1 Rodent-derived cell lines are widely used in the production of biopharmaceutical drugs such as mAbs and Fc fusion proteins. These cell lines have been shown to contain genes encoding endogenous retroviral-like particles or endogenous retrovirus. Despite the lack of evidence for an association between such rodent retroviruses and disease in humans, the potential contamination of human therapeutics raises safety concerns for biopharmaceutical drugs. Additionally, adventitious agents such as viruses can be introduced into a biopharmaceutical drug substance manufacturing process from other sources, and potential safety issues can be attributed to these potential unknowns. For these reasons, effective viral clearance is an essential aspect of an integrated approach combining safety testing and process characterization which ensures virus safety for biopharmaceutical drug products made using rodent cell lines.
3.2 Solvent/detergent inactivation has been widely used for decades to inactivate enveloped viruses in blood plasma derived biopharmaceutical therapies (1-3).3 Solvent/detergent systems using the detergents Triton X-100 or Polysorbate 80 along with the organic solvent tri(n-butyl)phosphate (TNBP) have been used to inactivate enveloped viruses by disrupting the viral envelope thereby reducing the ability of the enveloped virus to attach to and then infect the host cell (4 and 5).
3.3 Most manufacturers of mAbs, recombinant proteins, and Fc fusion proteins have focused on viral inactivation methods using the detergent Triton X-100 or Polysorbate 80 in the absence of TNBP (6), which can interfere with subsequent bioprocessing steps. The ability of the detergents alone to inactivate retroviruses has been demonstrated in monoclonal antibodies produced in rodent-derived cell lines (6-9). At a 2011 workshop devoted to viral clearance steps used in bioprocessing (7), investigators from one firm showed incubation with 0.2 % Triton X-100 for 60 min of hold time at a...
SCOPE
1.1 This practice assures effective inactivation of ≥4 log10 of infectious rodent retrovirus (that is, reduction from 10 000 to 1 infectious rodent retrovirus or removal of 99.99 % of infectious rodent retroviruses) in the manufacturing processes of monoclonal antibodies or immunoglobulin G (IgG) Fc fusion proteins manufactured in rodent-derived cell lines that do not target retroviral antigens. Rodent retrovirus is used as a model for rodent cell substrate endogenous retrovirus-like particles potentially present in the production stream of these proteins.
1.2 The parameters specified for this practice are clarification, Triton X-100 detergent concentration, hold time, pH, and inactivation temperature.
1.3 This practice can be used in conjunction with other clearance or inactivation unit operations that are orthogonal to this inactivation mechanism to achieve sufficient total process clearance or inactivation of rodent retrovirus.
1.4 This detergent inactivation step is performed on a clarified, cell-free intermediate of the monoclonal antibody or IgG Fc fusion protein.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 A common result of cellular stress is an increase in DNA damage. DNA damage may be manifest in the form of base alterations, adduct formation, strand breaks, and cross linkages (19). Strand breaks may be introduced in many ways, directly by genotoxic compounds, through the induction of apoptosis or necrosis, secondarily through the interaction with oxygen radicals or other reactive intermediates, or as a consequence of excision repair enzymes (20-22). In addition to a linkage with cancer, studies have demonstrated that increases in cellular DNA damage precede or correspond with reduced growth, abnormal development, and reduced survival of adults, embryos, and larvae (16, 23, 24).
5.1.1 The Comet assay can be easily utilized for collecting data on DNA strand breakage (9, 25, 26). It is a simple, rapid, and sensitive method that allows the comparison of DNA strand damage in different cell populations. As presented in this guide, the assay facilitates the detection of DNA single strand breaks and alkaline labile sites in individual cells, and can determine their abundance relative to control or reference cells (9, 16, 26). The assay offers a number of advantages; damage to the DNA in individual cells is measured, only extremely small numbers of cells need to be sampled to perform the assay ((2, 27) .
5.1.2 These are general guidelines. There are numerous procedural variants of this assay. The variation used is dependent upon the type of cells being examined, the types of DNA damage of interest, and the imaging and analysis capabilities of the lab conducting the assay. To visualize the DNA, it is stained with a fluorescent dye, or for light microscope analysis the DNA can be silver stained (28). Only fluorescent staining methods will be described in this guide. The microscopic determination of DNA migration can be made either by eye using an ocular micrometer or with the use of image analysis software. Scoring by eye can be performed using a calibrated ocular...
SCOPE
1.1 This guide covers the recommended criteria for performing a single-cell gel electrophoresis assay (SCG) or Comet assay for the measurement of DNA single-strand breaks in eukaryotic cells. The Comet assay is a very sensitive method for detecting strand breaks in the DNA of individual cells. The majority of studies utilizing the Comet assay have focused on medical applications and have therefore examined DNA damage in mammalian cells in vitro and in vivo (1-4).2 There is increasing interest in applying this assay to DNA damage in freshwater and marine organisms to explore the environmental implications of DNA damage.
1.1.1 The Comet assay has been used to screen the genotoxicity of a variety of compounds on cells in vitro and in vivo (5-7), as well as to evaluate the dose-dependent anti-oxidant (protective) properties of various compounds (3, 8-11). Using this method, significantly elevated levels of DNA damage have been reported in cells collected from organisms at polluted sites compared to reference sites (12-15). Studies have also found that increases in cellular DNA damage correspond with higher order effects such as decreased growth, survival, and development, and correlate with significant increases in contaminant body burdens (13, 16).
1.2 This guide presents protocols that facilitate the expression of DNA alkaline labile single-strand breaks and the determination of their abundance relative to control or reference cells. The guide is a general one meant to familiarize lab personnel with the basic requirements and considerations necessary to perform the Comet assay. It does not contain procedures for available variants of this assay, which allow the determination of non-alkaline labile single-strand breaks or double-stranded DNA strand breaks (8), distinction between different cell types (13), identification of cells undergoing apoptosis (programmed cell death, (1, 17)), measurement of cellular DNA repair...
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SIGNIFICANCE AND USE
5.1 Bacteria that exist in a biofilm are phenotypically different from suspended cells of the same genotype. The study of biofilm in the laboratory requires protocols that account for this difference. Laboratory biofilms are engineered in growth reactors designed to produce a specific biofilm type. Altering system parameters will correspondingly result in a change in the biofilm. The purpose of this method is to direct a user in the laboratory study of biofilms by clearly defining each system parameter. This method will enable a person to grow, sample, and analyze a laboratory biofilm. The method was originally developed to study toilet bowl biofilms, but may also be utilized for research that requires a biofilm grown under moderate fluid shear.
SCOPE
1.1 This test method is used for growing a reproducible (1)2 Pseudomonas aeruginosa biofilm in a continuously stirred tank reactor (CSTR) under medium shear conditions. In addition, the test method describes how to sample and analyze biofilm for viable cells.
1.2 Although this test method was created to mimic conditions within a toilet bowl, it can be adapted for the growth and characterization of varying species of biofilm (rotating disk reactor—repeatability and relevance (2)).
1.3 This test method describes how to sample and analyze biofilm for viable cells. Biofilm population density is recorded as log10 colony forming units per surface area (rotating disk reactor—efficacy test method (3)).
1.4 Basic microbiology training is required to perform this test method.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SCOPE
1.1 Microbiological test methods present challenges that are unique relative to chemical or physical parameters, because microbes proliferate, die off and continue to be metabolically active in samples after those samples have been drawn from their source.
1.1.1 Microbial activity depends on the presence of available water. Consequently, the detection and quantification of microbial contamination in fuels and lubricants is made more complicated by the general absence of available water from these fluids.
1.1.2 Detectability depends on the physiological state and taxonomic profile of microbes in samples. These two parameters are affected by various factors that are discussed in this guide, and contribute to microbial data variability.
1.2 This guide addresses the unique considerations that must be accounted for in the design and execution of interlaboratory studies intended to determine the precision of microbiological test methods designed to quantify microbial contamination in fuels, lubricants and similar low water-content (water activity
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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SIGNIFICANCE AND USE
5.1 Vegetative biofilm bacteria are phenotypically different from suspended planktonic cells of the same genotype. Biofilm growth reactors are engineered to produce biofilms with specific characteristics. Altering either the engineered system or operating conditions will modify those characteristics. The goal in biofilm research and efficacy testing is to choose the growth reactor that generates the most relevant biofilm for the particular study.
5.2 The purpose of this test method is to direct a user in how to grow, treat, sample and analyze a Pseudomonas aeruginosa biofilm using the MBEC Assay. Microscopically, the biofilm is sheet-like with few architectural details as seen in Harrison et al (6). The MBEC Assay was originally designed as a rapid and reproducible assay for evaluating biofilm susceptibility to antibiotics (2). The engineering design allows for the simultaneous evaluation of multiple test conditions, making it an efficient method for screening multiple disinfectants or multiple concentrations of the same disinfectant. Additional efficiency is added by including the neutralizer controls within the assay device. The small well volume is advantageous for testing expensive disinfectants, or when only small volumes of the disinfectant are available.
SCOPE
1.1 This test method specifies the operational parameters required to grow and treat a Pseudomonas aeruginosa biofilm in a high throughput screening assay known as the MBEC (trademarked)2 (Minimum Biofilm Eradication Concentration) Physiology and Genetics Assay. The assay device consists of a plastic lid with ninety-six (96) pegs and a corresponding receiver plate with ninety-six (96) individual wells that have a maximum 200 μL working volume. Biofilm is established on the pegs under batch conditions (that is, no flow of nutrients into or out of an individual well) with gentle mixing. The established biofilm is transferred to a new receiver plate for disinfectant efficacy testing.3, 4 The reactor design allows for the simultaneous testing of multiple disinfectants or one disinfectant with multiple concentrations, and replicate samples, making the assay an efficient screening tool.
1.2 This test method defines the specific operational parameters necessary for growing a Pseudomonas aeruginosa biofilm, although the device is versatile and has been used for growing, evaluating and/or studying biofilms of different species as seen in Refs (1-4).5
1.3 Validation of disinfectant neutralization is included as part of the assay.
1.4 This test method describes how to sample the biofilm and quantify viable cells. Biofilm population density is recorded as log10 colony forming units per surface area. Efficacy is reported as the log10 reduction of viable cells.
1.5 Basic microbiology training is required to perform this assay.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 Bacteria that exist in biofilms are phenotypically different from suspended cells of the same genotype. Research has shown that biofilm bacteria are more difficult to kill than suspended bacteria (5, 7). Laboratory biofilms are engineered in growth reactors designed to produce a specific biofilm type. Altering system parameters will correspondingly result in a change in the biofilm. For example, research has shown that biofilm grown under high shear is more difficult to kill than biofilm grown under low shear (5, 8). The purpose of this test method is to direct a user in the laboratory study of a Pseudomonas aeruginosa biofilm by clearly defining each system parameter. This test method will enable an investigator to grow, sample, and analyze a Pseudomonas aeruginosa biofilm grown under high shear. The biofilm generated in the CDC Biofilm Reactor is also suitable for efficacy testing. After the 48 h growth phase is complete, the user may add the treatment in situ or remove the coupons and treat them individually.
SCOPE
1.1 This test method specifies the operational parameters required to grow a reproducible (1)2 Pseudomonas aeruginosa ATCC 700888 biofilm under high shear. The resulting biofilm is representative of generalized situations where biofilm exists under high shear rather than being representative of one particular environment.
1.2 This test method uses the Centers for Disease Control and Prevention (CDC) Biofilm Reactor. The CDC Biofilm Reactor is a continuously stirred tank reactor (CSTR) with high wall shear. Although it was originally designed to model a potable water system for the evaluation of Legionella pneumophila (2), the reactor is versatile and may also be used for growing and/or characterizing biofilm of varying species (3-5).
1.3 This test method describes how to sample and analyze biofilm for viable cells. Biofilm population density is recorded as log10 colony forming units per surface area.
1.4 Basic microbiology training is required to perform this test method.
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 and health practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This guide provides a protocol for detecting, characterizing, and quantifying nucleic acids (that is, DNA) of living and recently dead microorganisms in fuels and fuel-associated waters by means of a culture independent qPCR procedure. Microbial contamination is inferred when elevated DNA levels are detected in comparison to the expected background DNA level of a clean fuel and fuel system.
5.2 A sequence of protocol steps is required for successful qPCR testing.
5.2.1 Quantitative detection of microorganisms depends on the DNA-extraction protocol and selection of appropriate oligonucleotide primers.
5.2.2 The preferred DNA extraction protocol depends on the type of microorganism present in the sample and potential impurities that could interfere with the subsequent qPCR reaction.
5.2.3 Primers vary in their specificity. Some 16S and 18S RNA gene regions present in the DNA of prokaryotic and eukaryotic microorganisms appear to have been conserved throughout evolution and thus provide a reliable and repeatable target for gene amplification and detection. Amplicons targeting these conserved nucleotide sequences are useful for quantifying total population densities. Other target DNA regions are specific to a metabolic class (for example, sulfate reducing bacteria) or individual taxon (for example, the bacterial species Pseudomonas aeruginosa). Primers targeting these unique nucleotide sequences are useful for detecting and quantifying specific microbes or groups of microbes known to be associated with biodeterioration.
5.3 Just as the quantification of microorganisms using microbial growth media employs standardized formulations of growth conditions enabling the meaningful comparison of data from different laboratories (Practice D6974), this guide seeks to provide standardization to detect, characterize, and quantify nucleic acids associated with living and recently dead microorganisms in fuel-associated samples using qPCR.
Note 3: Many primers, an...
SCOPE
1.1 This guide covers procedures for using quantitative polymerase chain reaction (qPCR), a genomic tool, to detect, characterize and quantify nucleic acids associated with microbial DNA present in liquid fuels and fuel-associated water samples.
1.1.1 Water samples that may be used in testing include, but are not limited to, water associated with crude oil or liquid fuels in storage tanks, fuel tanks, or pipelines.
1.1.2 While the intent of this guide is to focus on the analysis of fuel-associated samples, the procedures described here are also relevant to the analysis of water used in hydrotesting of pipes and equipment, water injected into geological formations to maintain pressure and/or facilitate the recovery of hydrocarbons in oil and gas recovery, water co-produced during the production of oil and gas, water in fire protection sprinkler systems, potable water, industrial process water, and wastewater.
1.1.3 To test a fuel sample, the live and recently dead microorganisms must be separated from the fuel phase which can include any DNA fragments by using one of various methods such as filtration or any other microbial capturing methods.
1.1.4 Some of the protocol steps are universally required and are indicated by the use of the word must. Other protocol steps are testing-objective dependent. At those process steps, options are offered and the basis for choosing among them are explained.
1.2 The guide describes the application of quantitative polymerase chain reaction (qPCR) technology to determine total bioburden or total microbial population present in fuel-associated samples using universal primers that allow for the quantification of 16S and 18S ribosomal RNA genes that are present in all prokaryotes (that is, bacteria and archaea) and eucaryotes (that is, mold and yeast collectively termed fungi), respectively.
1.3 This guide describes laboratory protocols. As described in Practice D7464, the...
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SIGNIFICANCE AND USE
5.1 Bacteria that exist in biofilms are phenotypically different from suspended cells of the same genotype. Research has shown that biofilm bacteria are more difficult to kill than suspended bacteria (4, 5). Laboratory biofilms are engineered in growth reactors designed to produce a specific biofilm type. Altering system parameters will correspondingly result in a change in the biofilm. The purpose of this practice is to direct a user in the growth of a P. aeruginosa or S. aureus biofilm by clearly defining the operational parameters to grow a biofilm that can be assessed for efficacy using the Standard Test Method for Evaluating Disinfectant Efficacy Against Pseudomonas aeruginosa Biofilm Grown in CDC Biofilm Reactor Using Single Tube Method (E2871).
5.2 Operating the CDC Biofilm Reactor at the conditions specified in this method generates biofilm at log densities (log10 CFU per coupon) ranging from 8.0 to 9.5 for P. aeruginosa and 7.5 to 9.0 for S. aureus. These levels of biofilm are anticipated on surfaces conducive to biofilm formation such as the conditions outlined in this method.
5.2.1 To achieve an S. aureus biofilm with a population comparable to that for P. aeruginosa using the bacterial liquid growth medium conditions specified here, the S. aureus biofilm must be grown at 36 °C ±2 °C rather than at room temperature (21 °C ±2 °C).
SCOPE
1.1 This practice specifies the parameters for growing a Pseudomonas aeruginosa (ATCC 15442) or Staphylococcus aureus (ATCC 6538) biofilm that can be used for disinfectant efficacy testing using the Test Method for Evaluating Disinfectant Efficacy Against Pseudomonas aeruginosa Biofilm Grown in CDC Biofilm Reactor Using Single Tube Method (E2871) or in an alternate method capable of accommodating the coupons used in the CDC Biofilm Reactor. The resulting biofilm is representative of generalized situations where biofilm exist on hard, non-porous surfaces under shear rather than being representative of one particular environment. Additional bacteria may be grown using the basic procedure outlined in this document, however, alternative preparation procedures for frozen stock cultures and biofilm generation (for example, medium concentrations, baffle speed, temperature, incubation times, coupon types, etc.) may be necessary.
1.2 This practice uses the CDC Biofilm Reactor created by the Centers for Disease Control and Prevention (1).2 The CDC Biofilm Reactor is a continuously stirred tank reactor (CSTR) with high wall shear. The reactor is versatile and may also be used for growing or characterizing various species of biofilm, or both (2-4) provided appropriate adjustments are made to the growth media and operational parameters of the reactor.
1.3 Basic microbiology training is required to perform this practice.
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this practice.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This practice is to help in the development of protocols to assess the survival, removal and/or inactivation of human pathogens or their surrogates in indoor air. It accommodates the testing of technologies based on physical (for example, UV light) and chemical agents (for example, vaporized hydrogen peroxide) or simple microbial removal by air filtration or a combination thereof.
5.2 While this practice is designed primarily for work with aerobic, mesophilic vegetative bacteria, it can be readily adapted to handle other classes of microbial pathogens or their surrogates.
5.3 The pieces of equipment given here are as examples only. Other similar devices may be used as appropriate.
SCOPE
1.1 This practice is to assess technologies for microbial decontamination of indoor air using a sealed, room-sized chamber (~24 m3) as recommended by the U.S. Environmental Protection Agency (3). The test microbe is aerosolized inside the chamber where a fan uniformly mixes the aerosols and keeps them airborne. Samples of the air are collected and assayed, firstly to determine the rates of physical and biological decay of the test microbe, and then to assess the air decontaminating activity of the technology under test as log10 or percentage reductions in viability per m3 (1). The air temperature and relative humidity (RH) in the chamber are measured and recorded during each test.
1.2 The chamber can be used to assess microbial survival in indoor air as well as to test the ability of physical (for example, ultraviolet light) and chemical agents (for example, vaporized hydrogen peroxide) to inactivate representative pathogens or their surrogates in indoor air.
1.3 This practice does not cover testing of microbial contamination introduced into the chamber as a dry powder.
1.4 This practice does not cover work with human pathogenic viruses, which require additional safety and technical considerations.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.
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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SIGNIFICANCE AND USE
5.1 There are no reproducible standardized protocols for preparing specimens used to evaluate the microbicidal efficacy of non-chemical treatments such as ultraviolet (UV), highenergy electron beam, or other forms of non-chemical antimicrobial technologies.
5.2 Conventional protocols for applying bioburdens to carriers (see Test Method E2197) cause cells to stack upon one another, thereby creating multiple cell layers in which cells in layers closer to the carrier are masked by cells in overlying layers, which makes relative comparison of different non-chemical antimicrobial treatments more difficult.
5.3 Steel and other metal carriers have asperities that can shield a percentage of the applied cells from direct exposure to electromagnetic irradiation.
5.4 The combined effects of 5.2 and 5.3 confound determination of the microbicidal effect of electromagnetic irradiation on test specimens.
5.5 The practice addresses these two confounding factors by:
5.5.1 Using glass microscope slides – the surfaces of which are asperity-free – as carriers.
5.5.2 Reliably depositing bacterial cells onto the carrier as a monolayer.
5.6 The resulting specimen ensures that all microbes deposited onto the carrier are exposed equally to the irradiation source thereby ensuring that the only variables are the controlled ones – starting inoculum concentration, wavelength (λ – in nm), exposure time(s), and resulting energy dose (J).
SCOPE
1.1 This practice provides a protocol for creating bacterial cell monolayers on a flat surface.
1.2 The cultures used and culture preparation steps in this Practice are similar to AOAC Method 961.02 and US EPA MB-06. However, test bacteria are applied to the carrier using an automated deposition device (6.2) rather than as a suspension droplet.
1.3 The carrier inspection protocol is similar to US EPA MB-03 except that carrier surfaces are inspected microscopically rather than visually, unaided.
1.4 A monolayer of cells eliminates the confounding effect caused by the shadowing effect of outer layers of bacteria stacked upon other bacteria on test specimens – thereby attenuating directed energy beams (that is, ultraviolet light, high-energy electron beams) before they can reach underlying cells.
1.5 An asperity-free surface eliminates the shadowing effect of specimen surface topology that can block direct exposure of target bacteria to non-chemical antimicrobial treatments.
1.6 This practice provides a reproducible target microbe and surface specimen to minimize specimen variability within and between testing facilities. This facilitates direct data comparisons among various non-chemical antimicrobial technologies.
1.6.1 Antimicrobial pesticides used in clinical and industrial applications are expected to overcome shadowing effects. However, this practice meets a need for a protocol that facilitates relative comparisons among non-chemical antimicrobial treatments.
1.6.2 This practice is not intended to satisfy or replace existing test requirements for liquid chemical antimicrobial treatments (for example Test Methods E1153 and E2197) or established regulatory agency performance standards such as US EPA MB-06.
1.7 This practice was validated using Staphylococcus aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 15442) using a protocol based on AOAC Method 961.02. If other cultures are used, the suitability of this practice must be confirmed by inspecting prepared surfaces, by using scanning electron microscopy (SEM) or comparable high-resolution microscopy.
1.8 The specimens prepared in accordance with this practice are not meant to simulate end-use conditions.
1.8.1 Non-chemical technologies are only to be used on visibly clean, non-porous surfaces. Consequently, a soil load is not used.
1.9 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.10 Th...
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SIGNIFICANCE AND USE
5.1 In the battle to reduce medical device and implant-related infections, prevention of bacterial colonization of surfaces is a logical strategy. Bacterial colonization of a surface is a precursor to biofilm formation. Biofilm is the etiological agent of many implant and device-related infections and once established, microorganisms in biofilm can be up to 1000 times more tolerant to antibiotic therapy. Often the best treatment strategy is removal of the implant or device at a high socioeconomic cost. Catheter associated urinary tract infections (CAUTI) are the most prevalent of the device-related healthcare associated infections. Catheter associated infections account for 37 % of all hospital acquired infections (HAI) and 70 % of all nosocomial urinary tract infections (UTI) in the U.S. (2, 3). The Intraluminal Catheter Model (ICM) was developed to evaluate the ability of antimicrobial catheters to inhibit biofilm growth on the catheter lumen.
5.2 The purpose of this test method is to direct a user in how to grow, sample, and analyze an E. coli biofilm in a urinary catheter under a constant flow of artificial urine. The test method incorporates operational parameters utilized in similar published methods (4). The E. coli biofilm that grows has a patchy appearance that varies across the catheter. Microscopically, the biofilm is heterogenous, with large clusters in some areas, and flat sheets of cells or even single cells in others. By 24 h, the biofilm is developed in the control catheters. If the goal is to monitor early stage biofilm development, then tubing and effluent samples need to be collected prior to the 24 h sample collection. Monitoring biofilm development requires sampling. The biofilm generated in the Intraluminal Catheter Model is suitable for comparison testing between antimicrobial and control catheters.
SCOPE
1.1 This test method specifies the operational parameters required to assess the ability of antimicrobial urinary catheters to prevent or control biofilm growth. Efficacy is reported as the log reduction in viable bacteria when compared to a repeatable (1)2 Escherichia coli biofilm grown in the intra-lumen of a urinary catheter under a constant flow of artificial urine.
1.2 The test method is versatile and may also be used for growing and/or characterizing biofilms and suspended bacteria of different species, although this will require changing the operational parameters to optimize the method based upon the growth requirements of the new organism.
1.3 This test method may be used to evaluate surface modified urinary catheters that contain no antimicrobial agent.
1.4 This test method describes how to sample and analyze catheter segments and effluent for viable cells. Biofilm population density is recorded as log colony forming units per surface area. Suspended bacterial population density is reported as log colony forming units per volume.
1.5 Basic microbiology training is required to perform this test method.
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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SIGNIFICANCE AND USE
5.1 Substrate–bonded, antimicrobial agents are not typically free to diffuse into their environment under normal conditions of use. This test method ensures good contact between the bacteria and the treated fiber, fabric, or other substrate, by constant agitation of the test specimen in a challenge suspension during the test period.
5.2 The metabolic state of the challenge species can directly affect measurements of the effectiveness of particular antimicrobial agents or concentrations of agents. The susceptibility of the species to particular biocides could be altered depending on its life stage (cycle). One-hour contact time in a buffer solution allows for metabolic stasis in the population. This test method standardizes both the growth conditions of the challenge species and substrate contact times to reduce the variability associated with growth phase of the microorganism.
5.3 Leaching of an antimicrobial is dependent upon the test conditions being utilized and the ultimate end use of the product. Additional testing may be required to determine if a compound is substrate-bound in all conditions or during the end use of the product.
5.4 This test method cannot determine if a compound is leaching into solution or is immobilized on the substrate. This test method is only intended to determine efficacy as described in subsequent portions of the method.
5.5 The test is suitable for evaluating stressed or modified specimens, when accompanied by adequate controls.
Note 1: Stresses may include laundry, wear and abrasion, radiation and steam sterilization, UV exposure, solvent manipulation, temperature susceptibility, or similar physical or chemical manipulation.
SCOPE
1.1 This test method is designed to evaluate the antimicrobial activity of antimicrobial-treated specimens under dynamic contact conditions. This dynamic shake flask test was developed for routine quality control and screening tests in order to overcome difficulties in using classical antimicrobial test methods to evaluate substrate-bound antimicrobials. These difficulties include ensuring contact of inoculum to treated surface (as in AATCC TM100), flexibility of retrieval at different contact times, use of inappropriately applied static conditions (as in AATCC TM147), sensitivity, and reproducibility.
1.2 This test method allows for the ability to evaluate many different types of treated substrates and a wide range of microorganisms. Treated substrates used in this test method can be subjected to a wide variety of physical/chemical stresses or manipulations and allows for the versatility of testing the effect of contamination due to such things as hard water, proteins, blood, serum, various chemicals, and other contaminants.
1.3 Surface antimicrobial activity is determined by comparing results from the test sample to controls run simultaneously.
1.4 This test method may not be appropriate for all types of antimicrobial-treated articles or antimicrobial agents. The proper test methodology should be determined based on antimicrobial mode of action and end-use expectations (Guide E2922)
1.5 Proper neutralization of all antimicrobials must be confirmed using Test Methods E1054.
1.6 This test method should be performed only by those trained in microbiological techniques.
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 may involve hazardous materials, operations and equipment. 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 ...
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SIGNIFICANCE AND USE
4.1 The Manual Observer-Dependent Assay-The manual quantification of cell and CFU cultures based on observer-dependent criteria or judgment is an extremely tedious and time-consuming task and is significantly impacted by user bias. In order to maintain consistency in data acquisition, pharmacological and drug discovery and development studies utilizing cell- and colony-based assays often require that a single observer count cells and colonies in hundreds, and potentially thousands of cultures. Due to observer fatigue, both accuracy and reproducibility of quantification suffer severely (5). When multiple observers are employed, observer fatigue is reduced, but the accuracy and reproducibility of cell and colony enumeration is still significantly compromised due to observer bias and significant intra- and inter-observer variability (2, 4) . Use of quantitative automated image analysis provides data for both the number of colonies as well as the number of cells in each colony. These data can also be used to calculate mean cells per colony. Traditional methods for quantification of colonies by hand-counting coupled with an assay for cell number (for example, DNA or mitochondrial) remains a viable method that can be used to calculate the mean number of cells per colony. These traditional methods have the advantage that they are currently less labor intensive and less technically demanding (8, 9). However, the traditional assays do not, provide colony level information (for example, variation and skew), nor do they provide a means for excluding cells that are not part of a colony from the calculation of mean colony size. As a result, the measurement of the mean number of cells per colony that is obtained from these alternative methods may differ when substantial numbers of cells in a sample are not associated with colony formation. By employing state-of-the-art image acquisition, processing and analysis hardware and software, an accurate, precise, robust and automated ana...
SCOPE
1.1 This practice, provided its limitations are understood, describes a procedure for quantitative measurement of the number and biological characteristics of colonies derived from a stem cell or progenitor population using image analysis.
1.2 This practice is applied in an in vitro laboratory setting.
1.3 This practice utilizes: (a) standardized protocols for image capture of cells and colonies derived from in vitro processing of a defined population of starting cells in a defined field of view (FOV), and (b) standardized protocols for image processing and analysis.
1.4 The relevant FOV may be two-dimensional or three-dimensional, depending on the CFU assay system being interrogated.
1.5 The primary unit to be used in the outcome of analysis is the number of colonies present in the FOV. In addition, the characteristics and sub-classification of individual colonies and cells within the FOV may also be evaluated, based on extant morphological features, distributional properties, or properties elicited using secondary markers (for example, staining or labeling methods).
1.6 Imaging methods require that images of the relevant FOV be captured at sufficient resolution to enable detection and characterization of individual cells and over a FOV that is sufficient to detect, discriminate between, and characterize colonies as complete objects for assessment.
1.7 Image processing procedures applicable to two- and three-dimensional data sets are used to identify cells or colonies as discreet objects within the FOV. Imaging methods may be optimized for multiple cell types and cell features using analytical tools for segmentation and clustering to define groups of cells related to each other by proximity or morphology in a manner that is indicative of a shared lineage relationship (that is, clonal expansion of a single founding stem cell or progenitor).
1.8 The characteristics of individual colony objects (cells ...
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This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories. This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.
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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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SIGNIFICANCE AND USE
4.1 Cell attachment or, lack of it, to biomaterials is a critical factor affecting the performance of a device or implant. Cell attachment is a complicated, time-dependent, process involving significant morphological changes of the cell and deposition of a bed of extracellular matrix. Details of the adhesive bond that is formed have been reviewed by, for example, Pierres et al (2002) (4), Lukas and Dvorak (2004) (5), and Garcia and Gallant (2003) (6). The strength of this coupling can be determined either by monitoring the force of attachment between a cell and a substrate over time or by measuring the force required to detach the cell once it has adhered.
4.2 Cell adhesion to a surface depends on a range of biological and physical factors that include the culture history, the age of the cell, the cell type, and both the chemistry and morphology of the underlying surface and time. These elements need to be considered in developing a test protocol.
4.3 Devising robust methods for measuring the propensity of cells to attach to different substrates is further complicated since either cell adhesion or detachment can be assessed. These processes are not always similar or complementary.
4.4 Most studies of cell attachment focus on obtaining some measure of the time-dependent force required to detach, or de-adhere, cells that have already adhered to a surface (James et al, 2005) (7). More recently investigators have begun to measure the adhesive forces that develop between cells and the underlying surface during attachment (Lukas and Dvorak, 2004) (5). From a practical point of view, it is much easier to measure the force required to detach or de-adhere cells from a surface than to measure those that develop during attachment. However, in both cases, the experimental data should be interpreted with a degree of caution that depends on the intended use of the measurements. The methods of measuring cell adhesion described herein are measures of the force required to ...
SCOPE
1.1 This guide describes protocols that can be used to measure the strength of the adhesive bond that develops between a cell and a surface as well as the force required to detach cells that have adhered to a substrate. Controlling the interactions of mammalian cells with surfaces is fundamental to the development of safe and effective medical products. This guide does not cover methods for characterizing surfaces. The information generated by these methods can be used to obtain quantitative measures of the susceptibility of surfaces to cell attachment as well as measures of the adhesion of cells to a surface. This guide also highlights the importance of cell culture history and influences of cell type.
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.
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.
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SIGNIFICANCE AND USE
5.1 This procedure describes a standardized method of processing cellulose wipes in a biosafety level 3 laboratory in order to detect and provide a semi-quantitative estimate of B. anthracis contamination after sampling of non-porous surfaces. Sampling may be conducted to characterize the extent of contamination or for clearance of an area after decontamination.
SCOPE
1.1 This test method covers a standardized method of processing cellulose wipes in a biosafety level 3 (BSL3) laboratory in order to detect and provide a semi-quantitative estimate of Bacillus anthracis contamination after sampling of non-porous surfaces. Sampling may be conducted to characterize the extent of the contamination, or for area clearance after decontamination.
1.2 The laboratory procedures should be performed in a BSL3 laboratory by those trained for BSL3 microbiological techniques.
1.3 This test method is specific to B. anthracis, but could be adapted for use with other organisms.
1.4 The interlaboratory study was conducted with cellulose sponge wipes pre-moistened with neutralizing buffer. All reproducibility, sensitivity, and specificity data are based on the performance of these wipes. A review was conducted by subcommittee in 2019, and re-confirmed these ILS data are valid.
1.5 Units—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.
1.6 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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SCOPE
1.1 This practice assures 5 log10 inactivation of non-defective C-type retroviruses, which are endogenous to murine hybridoma and CHO cells and are potentially present in the production stream of biopharmaceutical processes that use rodent derived cell culture.
1.2 The process parameters specified in this practice consistently assure 5 log10 inactivation of murine retrovirus by adjusting the pH of a process solution after initial affinity capture chromatography purification.
1.3 This practice is applicable to mAb, IgG fusion, or other recombinant proteins produced from rodent cell lines (for example, CHO or murine hybridoma), which do not target retroviral proteins. Additionally, the low pH step is performed on a cell-free intermediate, post initial capture using protein A chromatography.
1.4 The 5 log10 inactivation of murine retrovirus claimed by using this practice will be utilized in conjunction with other clearance unit operations (for example, chromatography and virus retentive filtration) to assure sufficient total process clearance of murine retroviruses, which will be supportive of early phase regulatory filings.
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 international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This test method determines the effectiveness of UVGI devices for reducing viable microorganisms deposited on carriers.
5.2 This test method evaluates the effect soiling agents have on UVGI antimicrobial effectiveness.
5.3 This test method determines the delivered UVGI dose.
SCOPE
1.1 This test method defines test conditions to evaluate ultraviolet germicidal irradiation (UVGI) light devices (mercury vapor bulbs, light-emitting diodes, or xenon arc lamps) that are designed to kill/inactivate influenza virus deposited on inanimate carriers.
1.2 This test method defines the terminology and methodology associated with the ultraviolet (UV) spectrum and evaluating UVGI dose.
1.3 This test method defines the testing considerations that can reduce UVGI surface kill effectiveness (that is, soiling).
1.4 Protocols for adjusting the UVGI dose to impact the reductions in levels of viable influenza virus are provided (Annex A1).
1.5 This test method does not address shadowing.
1.6 The test method should only be used by those trained in microbiology and in accordance with the guidance provided by Biosafety in Microbiological and Biomedical Laboratories.2
1.7 This test method is specific to influenza viruses
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.9 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location.
1.10 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.
1.11 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 Overview of Measurement System—Relative intensity measurements made by widefield epifluorescence microscopy are used as part of cell-based assays to quantify attributes such as the abundance of probe molecules (see ASTM F2997), fluorescently labeled antibodies, or fluorescence protein reporter molecules. The general procedure for quantifying relative intensities is to acquire digital images, then to perform image analysis to segment objects and compute intensities. The raw digital images acquired by epifluorescence microscopy are not typically amenable to relative intensity quantification because of the factors listed in 4.2. This guide offers a checklist of potential sources of bias that are often present in fluorescent microscopy images and suggests approaches for storing and normalizing raw image data to assure that computations are unbiased.
5.2 Areas of Application—Widefield fluorescence microscopy is frequently used to measure the location and abundance of fluorescent probe molecules within or between cells. In instances where RIM comparisons are made between a region of interest (ROI) and another ROI, accurate normalization procedures are essential to the measurement process to minimize biased results. Example use cases where this guidance document may be applicable include:
5.2.1 Characterization of cell cycle distribution by quantifying the abundance of DNA in individual cells (1).7
5.2.2 Measuring the area of positively stained mineralized deposits in cell cultures (ASTM F2997).
5.2.3 Quantifying the spread area of fixed cells (ASTM F2998).
5.2.4 Determining DNA damage in eukaryotic cells using the comet assay (ASTM E2186).
5.2.5 The quantitation of a secondary fluorescent marker that provides information related to the genotype, phenotype, biological activity, or biochemical features of a colony or cell (ASTM F2944).
SCOPE
1.1 This guidance document has been developed to facilitate the collection of microscopy images with an epifluorescence microscope that allow quantitative fluorescence measurements to be extracted from the images. The document is tailored to cell biologists that often use fluorescent staining techniques to visualize components of a cell-based experimental system. Quantitative comparison of the intensity data available in these images is only possible if the images are quantitative based on sound experimental design and appropriate operation of the digital array detector, such as a charge coupled device (CCD) or a scientific complementary metal oxide semiconductor (sCMOS) or similar camera. Issues involving the array detector and controller software settings including collection of dark count images to estimate the offset, flat-field correction, background correction, benchmarking of the excitation lamp and the fluorescent collection optics are considered.
1.2 This document is developed around epifluorescence microscopy, but it is likely that many of the issues discussed here are applicable to quantitative imaging in other fluorescence microscopy systems such as fluorescence confocal microscopy. This guide is developed around single-color fluorescence microscopy imaging or multi-color imaging where the measured fluorescence is spectrally well separated.
1.3 Fluorescence intensity is a relative measurement and does not in itself have an associated SI unit. This document does discuss metrology issues related to relative measurements and experimental designs that may be required to ensure quantitative fluorescence measurements are comparable after changing microscope, sample, and lamp configurations.
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 ...
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SIGNIFICANCE AND USE
5.1 Biofilm characteristics such as thickness, matrix architecture, and population are dependent on factors such as shear and nutrient availability and composition. Additionally, sporulation can occur within biofilms, including those formed by Bacillus subtilis.5 The purpose of this test method is to define the parameters to grow and enumerate a B. subtilis biofilm comprised of vegetative cells and spores embedded in extracellular polymeric substance (EPS). This type of biofilm could provide a greater challenge to antimicrobials than vegetative biofilm or spores alone. The biofilm generated using this method is suitable for efficacy testing of antimicrobials.
SCOPE
1.1 This test method specifies the operational parameters required to grow and quantify a Bacillus subtilis biofilm comprised of vegetative cells and endospores (spores) using the colony biofilm method (CBM).2,3 The resulting biofilm is representative of static environments that can develop a sporulating biofilm rather than being representative of one particular environment.
1.2 This test method utilizes a modified CBM to grow the biofilm. The CBM uses a semipermeable membrane on an agar plate as the biofilm growth surface and nutrient source.2,3 In this test method, membranes are inoculated and incubated for a total of 8 days to promote sporulation within the biofilm.
1.3 This test method describes how to sample and analyze the biofilm for vegetative cells and spores. Biofilm population is expressed as total colony forming units (CFU) and spores per membrane.
1.4 Basic microbiology training is required to perform this test method.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This practice determines the effectiveness of UVGI devices for reducing viable microorganisms deposited on carriers.
5.2 This practice evaluates the effect soiling agents have on UVGI antimicrobial effectiveness.
5.3 This practice determines the delivered UVGI dose.
SCOPE
1.1 This practice will define test conditions to evaluate ultraviolet germicidal irradiation (UVGI) light devices (mercury vapor bulbs, light-emitting diodes, or xenon arc lamps) that are designed to kill/inactivate microorganisms deposited on inanimate carriers.
1.2 This practice defines the terminology and methodology associated with the ultraviolet (UV) spectrum and evaluating UVGI dose.
1.3 This practice defines the testing considerations that can reduce UVGI surface kill effectiveness, that is, presence of a soiling agent.
1.4 This practice does not address shadowing.
1.5 This practice should only be used by those trained in microbiology and in accordance with the guidance provided by Biosafety in Microbiological and Biomedical Laboratories (5th edition), 2009, HHS Publication No. (CDC) 21-1112.
1.6 This practice does not recommend either specific test microbes or growth media. Users of this practice shall select appropriate test microbes and growth media based on the specific objectives of their UV antimicrobial performance evaluation test plan.
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 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, may be prohibited by local or national law.
1.9 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.
1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 The measurement of particulate matter is widely performed to characterize emissions from stationary sources in terms of emission concentrations and emission rates to the atmosphere for engineering and regulatory purposes.
5.2 This test method provides near real-time measurement results and is particularly well suited for use in performance assessment and optimization of particulate matter controls achieved by air pollution control devices or process modifications (including fuel, feed, or process operational changes) and performance assessments of particulate matter continuous emissions monitoring systems (PM CEMS)
5.3 This test method is well suited for measurement of particulate matter-laden gas streams in the range of 0.2 mg/m3 to 50 mg/m3, especially at low concentrations.
5.4 The U.S. EPA has concurred that this test method has been demonstrated to meet the Method 301 bias3 and precision criteria for measuring particulate matter from coal fired utility boilers when compared with EPA Method 17 and Method 5 (40CFR60, Appendix A).
5.5 This test method can accurately measure relative particulate matter concentrations over short intervals and can be used to assess the uniformity of particulate concentrations at various points on a measurement traverse within a duct or stack.
SCOPE
1.1 This test method describes the procedures for determining the mass concentration of particulate matter in gaseous streams using an automated, in-stack test method. This test method, an in-situ, inertial microbalance, is based on inertial mass measurement using a hollow tube oscillator. This test method is describes the design of the apparatus, operating procedure, and the quality control procedures required to obtain the levels of precision and accuracy stated.
1.2 This test method is suitable for collecting and measuring filterable particulate matter concentrations in the ranges 0.2 mg/m3 and above taken in effluent ducts and stacks.
1.3 This test method may be used for calibration of automated monitoring systems (AMS). If the emission gas contains unstable, reactive, or semi-volatile substances, the measurement will depend on the filtration temperature, and this test method (and other in-stack methods) may be more applicable than out-stack methods for the calibration of automated monitoring systems.
1.4 This test method can be employed in sources having gas temperature up to 200°C (392°F) and having gas velocities from 3 to 27 m/s.
1.5 This test method includes a description of equipment and methods to be used for obtaining and analyzing samples and a description of the procedure used for calculating the results.
1.6 This test method may also be limited from use in sampling gas streams that contain fluoride, or other reactive species having the potential to react with or within the sample train.
1.7 Appendix X1 provides procedures for assessment of the spatial variation in particulate matter (PM) concentration within the cross section of a stack or duct test location to determine whether a particular sampling point or limited number of sampling points can be used to acquire representative PM samples.
1.8 Appendix X2 provides procedures for reducing the sampling time required to perform calibrations of automated monitoring systems where representative PM samples can be acquired from a single sample point and certain other conditions are met.
1.9 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.
1.10 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.
1.11 This i...
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SIGNIFICANCE AND USE
5.1 The design of this test eliminates any loss of viable organisms through wash off, thus making it possible to produce statistically valid data using many fewer test carriers than needed for methods based on simple MPN estimates.
5.2 The stringency in the test is provided by the use of a soil load, the microtopography of the brushed stainless steel carrier surface, and the smaller ratio of test substance to surface area typical for many disinfectant applications. Thus, the test substance being assessed is presented with a reasonable challenge while allowing for efficient recovery of the test organisms from the inoculated carriers. The metal disks in the basic test are also compatible with a wide variety of actives.
5.3 The design of the carriers makes it possible to place onto each a precisely measured volume of the test organism (10 μL) as well as the control fluid or test substance (50 μL).
5.4 The inoculum is placed at the center of each disk whereas the volumes of the test substance covers nearly the entire disk surface, thus virtually eliminating the risk of any organisms remaining unexposed.
5.5 In all tests, other than those against viruses, the addition of 10 mL of an eluent/diluent gives a 1:200 dilution of the test substance immediately at the end of the contact time. While this step in itself may be sufficient to arrest the microbicidal activity of most actives, the test protocol permits the addition of a specific neutralizer to the eluent/diluent, if required. Except for viruses, the membrane filtration step also allows processing of the entire eluate from the test carriers and, therefore, the capture and subsequent detection of even low numbers of viable organisms that may be present. Subsequent rinsing of the membrane filters with saline also reduces the risk of carrying any inhibitory residues over to the recovery medium. Validation of the process of neutralization of the test substance is required by challenge with low numbers of the te...
SCOPE
1.1 This test method is designed to evaluate the ability of test substances to inactivate vegetative bacteria, viruses, fungi, mycobacteria, and bacterial spores (1-7) on disk carriers of brushed stainless steel that represent hard, nonporous environmental surfaces and medical devices. It is also designed to have survivors that can be compared to the mean of no less than three control carriers to determine if the performance standard has been met. For proper statistical evaluation of the results, the number of viable organisms in the test inoculum should be sufficiently high to take into account both the performance standard and the experimental variations in the results.
1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing wipes.
1.3 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (8).
1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions).
1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and metric units follow.
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 T...
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ISO 21528-1:2017 specifies a method, with enrichment, for the detection of Enterobacteriaceae. It is applicable to - products intended for human consumption and the feeding of animals, and - environmental samples in the area of primary production, food production and food handling. This method is applicable - when the microorganisms sought are expected to need resuscitation by enrichment, and - when the number sought is expected to be below 100 per millilitre or per gram of test sample. A limitation on the applicability of ISO 21528-1:2017 is imposed by the susceptibility of the method to a large degree of variability (see Clause 11). NOTE Enumeration can be carried out by calculation of the most probable number (MPN) after incubation in liquid medium. See Annex A.
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ISO 21528-2:2017 specifies a method for the enumeration of Enterobacteriaceae. It is applicable to - products intended for human consumption and the feeding of animals, and - environmental samples in the area of primary production, food production and food handling. This technique is intended to be used when the number of colonies sought is expected to be more than 100 per millilitre or per gram of the test sample. The most probable number (MPN) technique, as included in ISO 21528‑1, is generally used when the number sought is expected to be below 100 per millilitre or per gram of test sample.
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SIGNIFICANCE AND USE
3.1 The electrical sensing zone method for cell counting is used in tissue culture, government research, and hospital, biomedical, and pharmaceutical laboratories for counting and sizing cells. The method may be applicable to a wide range of cells sizes and cell types, with appropriate validation (10).
3.2 The electrical sensing zone methodology was introduced in the mid-1950s (9). Since this time, there have been substantial improvements which have enhanced the operator's ease of use. Among these are the elimination of the mercury manometer, reduced size, greater automation, and availability of comprehensive statistical computer programs.
3.3 This instrumentation offers a rapid result as contrasted to the manual counting of cells using the hemocytometer standard counting chamber. The counting chamber is known to have an error of 10 to 30 %, as well as being time-consuming (11). In addition, when counting and sizing porcine hepatocytes, Stegemann et al concluded that the automated, electrical sensing zone method provided greater accuracy, precision, and speed, for both counts and size, compared to the conventional microscopic or the cell mass-based method (7).
SCOPE
1.1 This test method, provided the limitations are understood, covers a procedure for both the enumeration and measurement of size distribution of most all cell types. The instrumentation allows for user-selectable cell size settings and is applicable to a wide range of cell types. The method works best for spherical cells, and may be less accurate if cells are not spherical, such as for discoid cells or budding yeast. The method is appropriate for suspension as well as adherent cell cultures (1).2 Results may be reported as number of cells per milliliter or total number of cells per volume of cell suspension analyzed. Size distribution may be expressed in cell diameter or volume.
1.2 Cells commonly used in tissue-engineered medical products (2) are analyzed routinely. Examples are chondrocytes (3), fibroblasts (4), and keratinocytes (5). Szabo et al. used the method for both pancreatic islet number and volume measurements (6). In addition, instrumentation using the electrical sensing zone technology was used for both count and size distribution analyses of porcine hepatocytes placed into hollow fiber cartridge extracorporeal liver assist systems. In this study (7), and others (6, 8), the automated electrical sensing zone method was validated for precision when compared to the conventional visual cell counting under a microscope using a hemocytometer. Currently, it is not possible to validate cell counting devices for accuracy, since there not a way to produce a reference sample that has a known number of cells. The electrical sensing zone method shall be validated each time it is implemented in a new laboratory, it is used on a new cell type, or the cell counting procedure is modified.
1.3 Electrical sensing zone instrumentation (commonly referred to as a Coulter counter) is manufactured by a variety of companies and is based upon electrical impedance. This test method, for cell counting and sizing, is based on the detection and measurement of changes in electrical resistance produced by a cell, suspended in a conductive liquid, traversing through a small aperture (see Fig. 1(9)). When cells are suspended in a conductive liquid, phosphate-buffered saline for instance, they function as discrete insulators. When the cell suspension is drawn through a small cylindrical aperture, the passage of each cell changes the impedance of the electrical path between two submerged electrodes located on each side of the aperture. An electrical pulse, suitable for both counting and sizing, results from the passage of each cell through the aperture. The path through the aperture, in which the cell is detected, is known as the “electronic sensing zone.” This test method permits the selective counting of cells within narrow size distrib...
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This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
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This European Standard specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
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This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
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This European Standard specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
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This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.
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This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
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This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the equipment includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
- Standard13 pagesEnglish languagee-Library read for1 day
This European Standard specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
- Standard8 pagesEnglish languagee-Library read for1 day
This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.
- Standard8 pagesEnglish languagee-Library read for1 day
This European Standard specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
- Standard11 pagesEnglish languagee-Library read for1 day
This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
- Standard10 pagesEnglish languagee-Library read for1 day
This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
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