07.100 - Microbiology
ICS 07.100 Details
Microbiology
Mikrobiologie
Microbiologie
Mikrobiologija
General Information
Frequently Asked Questions
ICS 07.100 is a classification code in the International Classification for Standards (ICS) system. It covers "Microbiology". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 1369 standards classified under ICS 07.100 (Microbiology). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document establishes basic principles and specifies requirements and methods to determine the cardinal values of bacteria and yeast strains and use them to predict microbial growth.
The four main steps of the approach are:
determination of the cardinal values in culture medium;
determination of the correction factor in the target food;
validation of the model;
simulations.
Four environmental factors are considered: temperature, pH, aw and inhibitors (e.g. organic acids).
NOTE 1 Microbial competition is not considered as an inhibitor in this document and can be addressed by proper modelling approaches.
The determination of cardinal values is performed in a two-step approach:
the determination of maximum specific growth rates of the studied strain grown in broth under a defined range of values of the studied environmental factor(s);
the use of recognized predictive microbiology secondary models to fit the obtained experimental data to obtain the cardinal values.
The use of cardinal values in microbial growth simulation is based on predictive microbiology primary and secondary models. The cardinal values are combined with challenge test data to consider the matrix effect. Depending on the goal of the growth simulation, it is important to account for variation of cardinal values between strains within a bacterial or yeast species.
Cardinal values are a good indicator of a strain growth ability for the studied environmental factors. They are therefore used as criteria to select strains, in addition to their origin and virulence, when performing growth challenge tests (see ISO 20976-1) or in methods validation (see ISO 16140 series).
NOTE 2 This document focuses on the determination of cardinal values for one strain. The same methodology can be used to characterize multiple strains independently to cover biological strain variability and include these results in the predictions.
- Standard56 pagesEnglish languagee-Library read for1 day
This document specifies microbiological cleanliness and preservative efficacy requirements for accessible aqueous media in toys.
The requirements in this document apply to all toys that are, contain or are supplied with accessible aqueous materials (e.g. paste, putty, finger paint, liquid or gel).
The cleanliness and preservation effectiveness requirements are applicable to a toy as it is initially received by the consumer, in an unopened and undamaged container. This document does not apply to a toy that has been used, has had its packaging opened or is otherwise compromised in a way that would introduce microbiological contamination.
This document does not apply to toys and samples which are post-consumer use, since the microbiological limits are inappropriate given, there is no way to establish what conditions the toys have been subject to before testing.
This document does not apply to:
- materials that are inaccessible during normal use or after reasonably foreseeable abuse;
- food;
- cosmetics;
- components of toys covered by EN 71-13 where;
- the component is in scope of the Cosmetic Products Regulation (i.e. Regulation (EC) No 1223/2009 [13];
- the component comprises only recognized food flavours and food ingredients (see relevant legislation, for example Regulation (EC) No 178/2002 [16] ("general food law"), Regulation (EC) No 1334/2008 [15] (flavours), Regulation (EC) No 1333/2008 [14], Commission Regulation (EU) No 231/2012 [18] (food additives) and Regulation (EU) No 1169/2011 (food information to consumers)[17]);
- experimental sets covered by EN 71-4.
NOTE Play cosmetics, that are only for use on the toy (e.g. makeup products only for a doll), are not excluded.
- Standard18 pagesEnglish languagee-Library read for1 day
This document establishes basic principles and specifies requirements and methods to determine the cardinal values of bacteria and yeast strains and use them to predict microbial growth.
The four main steps of the approach are:
determination of the cardinal values in culture medium;
determination of the correction factor in the target food;
validation of the model;
simulations.
Four environmental factors are considered: temperature, pH, aw and inhibitors (e.g. organic acids).
NOTE 1 Microbial competition is not considered as an inhibitor in this document and can be addressed by proper modelling approaches.
The determination of cardinal values is performed in a two-step approach:
the determination of maximum specific growth rates of the studied strain grown in broth under a defined range of values of the studied environmental factor(s);
the use of recognized predictive microbiology secondary models to fit the obtained experimental data to obtain the cardinal values.
The use of cardinal values in microbial growth simulation is based on predictive microbiology primary and secondary models. The cardinal values are combined with challenge test data to consider the matrix effect. Depending on the goal of the growth simulation, it is important to account for variation of cardinal values between strains within a bacterial or yeast species.
Cardinal values are a good indicator of a strain growth ability for the studied environmental factors. They are therefore used as criteria to select strains, in addition to their origin and virulence, when performing growth challenge tests (see ISO 20976-1) or in methods validation (see ISO 16140 series).
NOTE 2 This document focuses on the determination of cardinal values for one strain. The same methodology can be used to characterize multiple strains independently to cover biological strain variability and include these results in the predictions.
- Standard56 pagesEnglish languagee-Library read for1 day
This document establishes basic principles and specifies requirements and methods to determine the cardinal values of bacteria and yeast strains and use them to predict microbial growth. The four main steps of the approach are: determination of the cardinal values in culture medium; determination of the correction factor in the target food; validation of the model; simulations. Four environmental factors are considered: temperature, pH, aw and inhibitors (e.g. organic acids). NOTE 1 Microbial competition is not considered as an inhibitor in this document and can be addressed by proper modelling approaches. The determination of cardinal values is performed in a two-step approach: the determination of maximum specific growth rates of the studied strain grown in broth under a defined range of values of the studied environmental factor(s); the use of recognized predictive microbiology secondary models to fit the obtained experimental data to obtain the cardinal values. The use of cardinal values in microbial growth simulation is based on predictive microbiology primary and secondary models. The cardinal values are combined with challenge test data to consider the matrix effect. Depending on the goal of the growth simulation, it is important to account for variation of cardinal values between strains within a bacterial or yeast species. Cardinal values are a good indicator of a strain growth ability for the studied environmental factors. They are therefore used as criteria to select strains, in addition to their origin and virulence, when performing growth challenge tests (see ISO 20976-1) or in methods validation (see ISO 16140 series). NOTE 2 This document focuses on the determination of cardinal values for one strain. The same methodology can be used to characterize multiple strains independently to cover biological strain variability and include these results in the predictions.
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This document specifies the general requirements and provides guidance for the development and application of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain.
This document is applicable to all LAMP methods, platforms, and items from the food chain and laboratories.
This document does not apply to the use of LAMP for quantification.
Validation and verification of LAMP methods as either alternative or reference methods are not covered in this document. Both validation and verification of microbiological methods are described in detail in the ISO 16140 series and ISO 17468.
General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in ISO 22942-1, and general requirements and definitions for polymerase chain reaction (PCR) for the detection and quantification of microorganisms in the food chain are given in ISO 22174.
This document has been established for microorganisms in the food chain and is applicable to:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage for the above items.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies the minimum requirements for bacteriophage preparation processing including assessment on the titre and quality control. The document applies to data processing of bacteriophage isolation, culture, characterization and storage. This document applies to the quality evaluation/assessment of bacteriophage used for therapy.
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This document provides supplemental information and guidance on how to implement the requirements listed in ISO 35001 [1]. This document does not add requirements to those in ISO 35001 [1].
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This document specifies the general requirements and provides guidance for the development and application of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain.
This document is applicable to all LAMP methods, platforms, and items from the food chain and laboratories.
This document does not apply to the use of LAMP for quantification.
Validation and verification of LAMP methods as either alternative or reference methods are not covered in this document. Both validation and verification of microbiological methods are described in detail in the ISO 16140 series and ISO 17468.
General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in ISO 22942-1, and general requirements and definitions for polymerase chain reaction (PCR) for the detection and quantification of microorganisms in the food chain are given in ISO 22174.
This document has been established for microorganisms in the food chain and is applicable to:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage for the above items.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies a method for the enumeration of the characteristic microorganisms Lactobacillus delbrueckii subsp. bulgaricus (in short: L. bulgaricus) and Streptococcus thermophilus (in short: S. thermophilus) by means of the colony-count technique. The method is applicable to yoghurts (for the definition see CXS 243‑2003[7]). The colony-count technique (pour plates) is suitable for, but not limited to, the enumeration of L. bulgaricus and S. thermophilus in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of the characteristic microorganisms L. bulgaricus and S. thermophilus that is expected to be higher than 100 cfu/g. The colony-count technique (spread plates) is suitable for, but not limited to, the enumeration of L. bulgaricus and S. thermophilus in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of the characteristic microorganisms L. bulgaricus and S. thermophilus that is expected to be higher than 1 000 cfu/g.
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This document specifies the general requirements and provides guidance for the development and application of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain. This document is applicable to all LAMP methods, platforms, and items from the food chain and laboratories. This document does not apply to the use of LAMP for quantification. Validation and verification of LAMP methods as either alternative or reference methods are not covered in this document. Both validation and verification of microbiological methods are described in detail in the ISO 16140 series and ISO 17468. General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in ISO 22942-1, and general requirements and definitions for polymerase chain reaction (PCR) for the detection and quantification of microorganisms in the food chain are given in ISO 22174. This document has been established for microorganisms in the food chain and is applicable to: — products intended for human consumption; — products for feeding animals; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage for the above items.
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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.
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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 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.
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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 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 a method for the enumeration of intestinal enterococci in water, including Enterococcus faecalis, Enterococcus faecium, Enterococcus durans, Enterococcus avium, Enterococcus gallinarum, Enterococcus hirae, Enterococcus casselifavus. The method is based on the growth of target organisms in a liquid medium and calculation of the “most probable number” (MPN) of microorganisms by reference to MPN tables or using suitable MPN informatic programs.
This method can be applied to drinking water and bathing water (fresh or marine), together with other similar water types including those containing an appreciable amount of suspended matter, and allows the detection of enterococci at 1 colony-forming unit (CFU) per 100 ml with definitive results within (26 ± 2) h in the presence of heterotrophic bacteria in numbers as high as 1 × 106 per 100 ml of sample.
For bathing waters, fresh and marine, enterococci are best enumerated when samples are diluted 1:10.
The test specified in this document relies upon the detection of intestinal enterococci based upon expression of the enzyme ß-D-glucosidase and provides a confirmed result in 24 h without further testing of positive wells.
This document does not apply to bottled waters, for which the method has not been validated and therefore is outside the scope of this document, unless appropriate validation of performance of this method has been undertaken by the laboratory prior to use.
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This document specifies a method for the enumeration of intestinal enterococci in water, including Enterococcus faecalis, Enterococcus faecium, Enterococcus durans, Enterococcus avium, Enterococcus gallinarum, Enterococcus hirae, Enterococcus casselifavus. The method is based on the growth of target organisms in a liquid medium and calculation of the “most probable number” (MPN) of microorganisms by reference to MPN tables or using suitable MPN informatic programs.
This method can be applied to drinking water and bathing water (fresh or marine), together with other similar water types including those containing an appreciable amount of suspended matter, and allows the detection of enterococci at 1 colony-forming unit (CFU) per 100 ml with definitive results within (26 ± 2) h in the presence of heterotrophic bacteria in numbers as high as 1 × 106 per 100 ml of sample.
For bathing waters, fresh and marine, enterococci are best enumerated when samples are diluted 1:10.
The test specified in this document relies upon the detection of intestinal enterococci based upon expression of the enzyme ß-D-glucosidase and provides a confirmed result in 24 h without further testing of positive wells.
This document does not apply to bottled waters, for which the method has not been validated and therefore is outside the scope of this document, unless appropriate validation of performance of this method has been undertaken by the laboratory prior to use.
- Standard18 pagesEnglish languagee-Library read for1 day
This document specifies a method for the enumeration of intestinal enterococci in water, including Enterococcus faecalis, Enterococcus faecium, Enterococcus durans, Enterococcus avium, Enterococcus gallinarum, Enterococcus hirae, Enterococcus casselifavus. The method is based on the growth of target organisms in a liquid medium and calculation of the “most probable number” (MPN) of microorganisms by reference to MPN tables or using suitable MPN informatic programs. This method can be applied to drinking water and bathing water (fresh or marine), together with other similar water types including those containing an appreciable amount of suspended matter, and allows the detection of enterococci at 1 colony-forming unit (CFU) per 100 ml with definitive results within (26 ± 2) h in the presence of heterotrophic bacteria in numbers as high as 1 × 106 per 100 ml of sample. For bathing waters, fresh and marine, enterococci are best enumerated when samples are diluted 1:10. The test specified in this document relies upon the detection of intestinal enterococci based upon expression of the enzyme ß-D-glucosidase and provides a confirmed result in 24 h without further testing of positive wells. This document does not apply to bottled waters, for which the method has not been validated and therefore is outside the scope of this document, unless appropriate validation of performance of this method has been undertaken by the laboratory prior to use.
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This document specifies a real-time PCR procedure for the quantitation of the amount of roe deer DNA relative to total mammalian DNA in meat and meat products.
Results of this roe deer assay are expressed in terms of roe deer (Capreolus capreolus) haploid genome copy numbers relative to total mammalian haploid genome copy numbers. The content of roe deer can also be expressed as mass fraction in % using gravimetrically prepared calibration material from meat mixtures or model samples.
The method has been previously validated in a collaborative study and applied to DNA extracted from samples that consist of raw roe deer meat in a raw pig meat background as well as raw and boiled sausages.
The limit of detection of the roe deer PCR has been determined experimentally to be at least 5 target gene copies or at least 0,1 % roe deer.
The compliance assessment process is not part of this document.
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This document specifies a real-time PCR procedure for the quantitation of the amount of roe deer DNA relative to total mammalian DNA in meat and meat products.
Results of this roe deer assay are expressed in terms of roe deer (Capreolus capreolus) haploid genome copy numbers relative to total mammalian haploid genome copy numbers. The content of roe deer can also be expressed as mass fraction in % using gravimetrically prepared calibration material from meat mixtures or model samples.
The method has been previously validated in a collaborative study and applied to DNA extracted from samples that consist of raw roe deer meat in a raw pig meat background as well as raw and boiled sausages.
The limit of detection of the roe deer PCR has been determined experimentally to be at least 5 target gene copies or at least 0,1 % roe deer.
The compliance assessment process is not part of this document.
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies a horizontal in vitro method for the molecular identification and differentiation of the monophasic variant of Salmonella enterica subsp. enterica serovar Typhimurium (1,4,[5],12:i:-) lacking the second H phase H:1,2, starting from isolates. The method detects specific DNA sequences of an intergenic region of the first H phase flagellin cluster for identification of Salmonella enterica subsp. enterica serovar Typhimurium (further called Salmonella Typhimurium) and specific DNA sequences of genes associated with second H phase flagellar antigen expression.
The method is applicable for:
— differentiation of the isolate under analysis between monophasic Salmonella Typhimurium and the monophasic variant of another Salmonella non-Typhimurium serovar that has the same antigenic formula;
— identification of the isolate under analysis being either monophasic Salmonella Typhimurium or (biphasic) Salmonella Typhimurium.
This document is applicable for the analysis of a pure culture belonging to the genus Salmonella, isolated from:
— products intended for human consumption;
— products intended for animal feeding;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
This document can also be applied in other domains for identification of monophasic Salmonella Typhimurium (e.g. environmental, human health, animal health).
NOTE This method has been validated in a method evaluation study and in an interlaboratory study with a large set of different strains (target and non-target strains), isolated from different sources (food products, animals, animal feed, primary production samples and humans). For detailed information on the validation, see Annex E.
- Standard40 pagesEnglish languagee-Library read for1 day
This document specifies a horizontal in vitro method for the molecular identification and differentiation of the monophasic variant of Salmonella enterica subsp. enterica serovar Typhimurium (1,4,[5],12:i:-) lacking the second H phase H:1,2, starting from isolates. The method detects specific DNA sequences of an intergenic region of the first H phase flagellin cluster for identification of Salmonella enterica subsp. enterica serovar Typhimurium (further called Salmonella Typhimurium) and specific DNA sequences of genes associated with second H phase flagellar antigen expression.
The method is applicable for:
— differentiation of the isolate under analysis between monophasic Salmonella Typhimurium and the monophasic variant of another Salmonella non-Typhimurium serovar that has the same antigenic formula;
— identification of the isolate under analysis being either monophasic Salmonella Typhimurium or (biphasic) Salmonella Typhimurium.
This document is applicable for the analysis of a pure culture belonging to the genus Salmonella, isolated from:
— products intended for human consumption;
— products intended for animal feeding;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
This document can also be applied in other domains for identification of monophasic Salmonella Typhimurium (e.g. environmental, human health, animal health).
NOTE This method has been validated in a method evaluation study and in an interlaboratory study with a large set of different strains (target and non-target strains), isolated from different sources (food products, animals, animal feed, primary production samples and humans). For detailed information on the validation, see Annex E.
- Standard40 pagesEnglish languagee-Library read for1 day
This document specifies a horizontal in vitro method for the molecular identification and differentiation of the monophasic variant of Salmonella enterica subsp. enterica serovar Typhimurium (1,4,[5],12:i:-) lacking the second H phase H:1,2, starting from isolates. The method detects specific DNA sequences of an intergenic region of the first H phase flagellin cluster for identification of Salmonella enterica subsp. enterica serovar Typhimurium (further called Salmonella Typhimurium) and specific DNA sequences of genes associated with second H phase flagellar antigen expression. The method is applicable for: — differentiation of the isolate under analysis between monophasic Salmonella Typhimurium and the monophasic variant of another Salmonella non-Typhimurium serovar that has the same antigenic formula; — identification of the isolate under analysis being either monophasic Salmonella Typhimurium or (biphasic) Salmonella Typhimurium. This document is applicable for the analysis of a pure culture belonging to the genus Salmonella, isolated from: — products intended for human consumption; — products intended for animal feeding; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage. This document can also be applied in other domains for identification of monophasic Salmonella Typhimurium (e.g. environmental, human health, animal health). NOTE This method has been validated in a method evaluation study and in an interlaboratory study with a large set of different strains (target and non-target strains), isolated from different sources (food products, animals, animal feed, primary production samples and humans). For detailed information on the validation, see Annex E.
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ISO 10705-3:2003 specifies the general principles for assessing the performance of methods for the concentration of bacteriophages from water. Concentration is recommended for those water samples expected to contain < 3 pfp (plaque-forming particles) per millilitre. Concentration methods can be applied to all kinds of water provided that the amount and nature of suspended solids and/or dissolved matter do not interfere with the concentration procedure.
ISO 10705-3:2003 does not give specific details of concentration methods, but outlines the fundamental principles for evaluating the suitability of a particular method for a given type and volume of water. Annex A gives examples of methods that have been found satisfactory and their fields of application.
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This document specifies a real-time PCR procedure for the quantitation of the amount of equine DNA relative to total mammalian DNA in a raw meat sample.
Results of this equine assay are expressed in terms of equine (Equus genus) haploid genome copy numbers relative to total mammalian haploid genome copy numbers. This assay is specific for representatives of the genus Equus and therefore detects horse, mule, donkey and zebra DNA.
The method has been previously validated in a collaborative study and applied to DNA extracted from samples that consist of raw horse meat in a raw beef (meat) background.
The limit of detection has been determined experimentally to be at least 17 horse haploid genome equivalents (HGE) for both the equine PCR and the mammalian PCR based on the lowest dilution on the respective calibration curves through single laboratory validation. The lowest relative horse content of the target sequence included in the collaborative study was a mass fraction of 0,1 % based on gravimetrically prepared raw horse muscle tissue in a raw beef muscle tissue background.
The compliance assessment process is not part of this document.
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This document specifies a real-time PCR procedure for the quantitation of the amount of equine DNA relative to total mammalian DNA in a raw meat sample.
Results of this equine assay are expressed in terms of equine (Equus genus) haploid genome copy numbers relative to total mammalian haploid genome copy numbers. This assay is specific for representatives of the genus Equus and therefore detects horse, mule, donkey and zebra DNA.
The method has been previously validated in a collaborative study and applied to DNA extracted from samples that consist of raw horse meat in a raw beef (meat) background.
The limit of detection has been determined experimentally to be at least 17 horse haploid genome equivalents (HGE) for both the equine PCR and the mammalian PCR based on the lowest dilution on the respective calibration curves through single laboratory validation. The lowest relative horse content of the target sequence included in the collaborative study was a mass fraction of 0,1 % based on gravimetrically prepared raw horse muscle tissue in a raw beef muscle tissue background.
The compliance assessment process is not part of this document.
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This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.
This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:
— the reference method;
— an alternative method validated in accordance with ISO 16140-2;
— an alternative method validated in accordance with ISO 16140-6.
In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.
This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.
- Standard46 pagesEnglish languagee-Library read for1 day
This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.
This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:
— the reference method;
— an alternative method validated in accordance with ISO 16140-2;
— an alternative method validated in accordance with ISO 16140-6.
In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.
This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.
- Standard46 pagesEnglish languagee-Library read for1 day
This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used. This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from: — products intended for human consumption; — products for feeding animals; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage. Identification methods only validated in accordance with this document cannot be used instead of confirmation described in: — the reference method; — an alternative method validated in accordance with ISO 16140-2; — an alternative method validated in accordance with ISO 16140-6. In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method. This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.
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This document specifies the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA).
This document is applicable to the testing for microorganisms and viruses from the food chain using the polymerase chain reaction (PCR). This document, or parts of it, is applicable to other fields of PCR diagnostics based on a case-by-case evaluation.
The minimum requirements laid down in this document are intended to ensure that comparable and reproducible results are obtained in different laboratories.
This document has been established for microorganisms from the food chain and is applicable to:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
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This document specifies the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA).
This document is applicable to the testing for microorganisms and viruses from the food chain using the polymerase chain reaction (PCR). This document, or parts of it, is applicable to other fields of PCR diagnostics based on a case-by-case evaluation.
The minimum requirements laid down in this document are intended to ensure that comparable and reproducible results are obtained in different laboratories.
This document has been established for microorganisms from the food chain and is applicable to:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
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This document specifies the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA). This document is applicable to the testing for microorganisms and viruses from the food chain using the polymerase chain reaction (PCR). This document, or parts of it, is applicable to other fields of PCR diagnostics based on a case-by-case evaluation. The minimum requirements laid down in this document are intended to ensure that comparable and reproducible results are obtained in different laboratories. This document has been established for microorganisms from the food chain and is applicable to: — products intended for human consumption; — products for feeding animals; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage.
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ISO 10705-3:2003 specifies the general principles for assessing the performance of methods for the concentration of bacteriophages from water. Concentration is recommended for those water samples expected to contain < 3 pfp (plaque-forming particles) per millilitre. Concentration methods can be applied to all kinds of water provided that the amount and nature of suspended solids and/or dissolved matter do not interfere with the concentration procedure.
ISO 10705-3:2003 does not give specific details of concentration methods, but outlines the fundamental principles for evaluating the suitability of a particular method for a given type and volume of water. Annex A gives examples of methods that have been found satisfactory and their fields of application.
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This document specifies general requirements and gives guidance on microbiological examinations.
It is applicable to:
— the implementation of specific horizontal or vertical International Standards developed by ISO/TC 34/SC 9 or ISO/TC 34/SC 5 for detection or enumeration of microorganisms, named hereafter “specific standards”;
— good laboratory practices for microbiology laboratories testing samples from the food chain;
— guidance for microbiological laboratories testing samples from the food chain on the technical requirements for conforming to ISO/IEC 17025.
The requirements of this general standard supersede corresponding ones in existing specific standards.
Additional instructions for examinations using the polymerase chain reaction (PCR) are specified in ISO 22174.
This document is applicable to examinations for bacteria, yeasts and moulds and can be used, if supplemented with specific guidance, for parasites and viruses. It does not apply to examinations for toxins or other metabolites (e.g. amines) from microorganisms.
This document is applicable to microbiology of the food chain, from primary production stage to food and animal feed products, including the premises where the food or feed production and handling takes place. It is also applicable to the microbiological examination of water where water is used in food production or is regarded as a food in national legislation.
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