07.100 - Microbiology
ICS 07.100 Details
Microbiology
Mikrobiologie
Microbiologie
Mikrobiologija
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This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.
- Standard16 pagesEnglish languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
This document gives requirements and recommendations for installation, commissioning and routine testing of BSC.
- Standard16 pagesEnglish languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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.
- Standard10 pagesEnglish languagesale 15% off
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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 languagesale 10% offe-Library read for1 day
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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
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.
- Standard20 pagesEnglish languagesale 10% offe-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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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.
- Standard13 pagesEnglish languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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.
- Standard26 pagesEnglish languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
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.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
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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.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
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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This document specifies the detection of Clostridium (C.) perfringens.
This document is applicable to:
— 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 horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
NOTE Interlaboratory studies with a small number of participating laboratories (<10) were conducted for the following food categories:
— ready-to-eat, ready-to-reheat meat products;
— eggs and egg products (derivates);
— ready-to-eat, ready-to-reheat fishery products;
— processed fruits and vegetables;
— infant formula and infant cereals (with probiotics);
— multi-component foods or meal components.
It has also been validated with a small number of participating laboratories for the following other category:
— environmental samples (food or feed production).
Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category. The method has not been validated for the category ‘pet food and animal feed’, as the test samples used for the interlaboratory study were already naturally contaminated with C. perfringens. Given the limited number of participating laboratories in the interlaboratory studies, the calculated performance characteristics can be used as indicative values of the method performance. For detailed information on the validation, see Clause 11 and Annexes C to F.
- Technical specification42 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies minimum performance requirements for methods that quantify the food allergens milk, egg, peanut, hazelnut, almond, brazil nut, macadamia nut, cashew, pistachio nut, walnut, pecan nut, lupine, sesame, mustard, soy, celery, fish, molluscs, crustaceans, and wheat in raw and processed foodstuffs. Within the scope of this document, minimum requirements for an LOQ (Limit of Quantification) will be derived from threshold data of allergic consumers. For quantitative antibody-based methods, a normative annex will describe what specific information the method developer needs to deliver and how performance characteristics shall be validated. Regarding PCR and LC-MS/MS, information on performance characteristics are in parts covered by EN 15634-1 and EN 17644. This document does not apply to fragmented or hydrolysed food allergens, such as casein hydrolysates or soy sauce. It also does not apply to methods that deliver qualitative results only. Methods that cover gluten-containing cereals (wheat, rye, and barley) with regard to coeliac disease are covered by EN 17254.
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- Standard19 pagesEnglish languagesale 10% offe-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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This document specifies minimum performance requirements for methods that quantify the food allergens milk, egg, peanut, hazelnut, almond, brazil nut, macadamia nut, cashew, pistachio nut, walnut, pecan nut, lupine, sesame, mustard, soy, celery, fish, molluscs, crustaceans, and wheat in raw and processed foodstuffs. Within the scope of this document, minimum requirements for an LOQ (Limit of Quantification) will be derived from threshold data of allergic consumers. For quantitative antibody-based methods, a normative annex will describe what specific information the method developer needs to deliver and how performance characteristics shall be validated. Regarding PCR and LC-MS/MS, information on performance characteristics are in parts covered by EN 15634-1 and EN 17644. This document does not apply to fragmented or hydrolysed food allergens, such as casein hydrolysates or soy sauce. It also does not apply to methods that deliver qualitative results only. Methods that cover gluten-containing cereals (wheat, rye, and barley) with regard to coeliac disease are covered by EN 17254.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the detection of Clostridium (C.) perfringens.
This document is applicable to:
— 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 horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
NOTE Interlaboratory studies with a small number of participating laboratories (<10) were conducted for the following food categories:
— ready-to-eat, ready-to-reheat meat products;
— eggs and egg products (derivates);
— ready-to-eat, ready-to-reheat fishery products;
— processed fruits and vegetables;
— infant formula and infant cereals (with probiotics);
— multi-component foods or meal components.
It has also been validated with a small number of participating laboratories for the following other category:
— environmental samples (food or feed production).
Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category. The method has not been validated for the category ‘pet food and animal feed’, as the test samples used for the interlaboratory study were already naturally contaminated with C. perfringens. Given the limited number of participating laboratories in the interlaboratory studies, the calculated performance characteristics can be used as indicative values of the method performance. For detailed information on the validation, see Clause 11 and Annexes C to F.
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This document specifies the detection of Clostridium (C.) perfringens. This document is applicable to: — 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 horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method. NOTE Interlaboratory studies with a small number of participating laboratories ( — ready-to-eat, ready-to-reheat meat products; — eggs and egg products (derivates); — ready-to-eat, ready-to-reheat fishery products; — processed fruits and vegetables; — infant formula and infant cereals (with probiotics); — multi-component foods or meal components. It has also been validated with a small number of participating laboratories for the following other category: — environmental samples (food or feed production). Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category. The method has not been validated for the category ‘pet food and animal feed’, as the test samples used for the interlaboratory study were already naturally contaminated with C. perfringens. Given the limited number of participating laboratories in the interlaboratory studies, the calculated performance characteristics can be used as indicative values of the method performance. For detailed information on the validation, see Clause 11 and Annexes C to F.
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This document provides the guidelines, minimum requirements and performance characteristics intended to guarantee that manufactured systems intended for on-site/field use (i.e. outside the laboratory) provide reliable and reproducible results. This document specifies the requirements for technologies that enable on-site detection and quantification of Legionella spp. and L. pneumophila using a quantitative polymerase chain reaction assay (qPCR). It specifies general methodological requirements, performance evaluation requirements and quality control requirements. This document is intended to be used by manufacturers of these technologies so that they produce detection systems that end users can operate safely and effectively. End users will be guided by this document to adhere to manufacturer’s instructions, to ensure user competency and to perform the necessary controls. Technical details specified in this document are given for information only. Any other technical solutions complying with the performance requirements are suitable. NOTE For validation and performance requirements, see Clause 9. This document is intended to be applied in the bacteriological investigation of all types of water (hot or cold water, cooling tower water, etc.), unless the nature and/or content of suspended matter and/or background microorganisms interfere with the determination. This interference can result in an adverse effect on both the detection limit and the quantification limit. The results are expressed as the number of genome units of Legionella spp. and/or L. pneumophila per millilitre (or litre) of sample. Although the method described in this document is applicable to all types of water, some additives, such as chemicals used for water treatment, can interfere with and/or affect the sensitivity of the method. The qPCR methods do not give any information about the physiological state of the Legionella. However, there are on-site qPCR methodologies which are able to distinguish intact bacteria from free DNA.
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