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.

  • Standard
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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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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 part of ISO 15213 is applicable to:
• products intended for human consumption;
• products intended for animal feeding;
• environmental samples in the area of food and feed production, handling, and;
• samples from the primary production stage.
This technique is intended to be used when the number of colonies sought is expected to be more than 10 per ml or per g of the test sample.

  • Technical specification
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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.

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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.

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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.

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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.

  • Technical specification
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This document gives technical requirements and guidance on the establishment or revision of
standardized reference methods used for the analysis of microorganisms in:
— 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.
This document specifies the technical stages of the establishment of a new standardized reference
method and of the revision of an existing standardized reference method. It includes, in particular,
requirements and guidance on the validation of the selected method.
This document is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding
structure at CEN level, which is CEN/TC 463.

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This document specifies the enumeration of Clostridium (C.) perfringens by colony-count technique.
This document 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.
NOTE This method has been validated in an interlaboratory study for the following food categories:
— ready-to-eat, ready-to-reheat meat products;
— eggs and egg products (derivates);
— processed fruits and vegetables;
— infant formula and infant cereals;
— multi-component foods or meal components.
It has also been validated for the following other categories:
— pet food and animal feed;
— environmental samples (food or feed production).
As this method has been validated for at least five food categories, this method is applicable for a broad range of
food. For detailed information on the validation, see Clause 11 and Annex C. 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.
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.
This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples
with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is
expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

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

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    25 pages
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This document specifies the enumeration of Clostridium (C.) perfringens by colony-count technique.
This document 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.
NOTE            This method has been validated in an interlaboratory study for the following food categories:
—     ready-to-eat, ready-to-reheat meat products;
—     eggs and egg products (derivates);
—     processed fruits and vegetables;
—     infant formula and infant cereals;
—     multi-component foods or meal components.
It has also been validated for the following other categories:
—     pet food and animal feed;
—     environmental samples (food or feed production).
As this method has been validated for at least five food categories, this method is applicable for a broad range of food. For detailed information on the validation, see Clause 11 and Annex C. 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.
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.
This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

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This document gives technical requirements and guidance on the establishment or revision of standardized reference methods used for the analysis of microorganisms in:
—    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.
This document specifies the technical stages of the establishment of a new standardized reference method and of the revision of an existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method.
This document is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding structure at CEN level, which is CEN/TC 463.

  • Standard
    20 pages
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This document specifies the enumeration of Clostridium (C.) perfringens by colony-count technique. This document 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. NOTE This method has been validated in an interlaboratory study for the following food categories: — ready-to-eat, ready-to-reheat meat products; — eggs and egg products (derivates); — processed fruits and vegetables; — infant formula and infant cereals; — multi-component foods or meal components. It has also been validated for the following other categories: — pet food and animal feed; — environmental samples (food or feed production). As this method has been validated for at least five food categories, this method is applicable for a broad range of food. For detailed information on the validation, see Clause 11 and Annex C. 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. 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. This technique is suitable for, but not limited to, the enumeration of microorganisms in test samples with a minimum of 10 colonies counted on a plate. This corresponds to a level of contamination that is expected to be higher than 10 cfu/ml for liquid samples or higher than 100 cfu/g for solid samples.

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This document specifies the minimum requirements for quality control of microbiological culture
media and diluents in order to demonstrate their ability to detect microorganisms and to ensure
reliability of the microbiological test methods described in the ISO cosmetics microbiology standards.
This document describes mainly growth promotion and microbial control tests and is applicable to
both commercially ready-to-use culture media and culture media prepared from dehydrated culture
media or basic constituents in the user’s laboratory.
Other methods can be substituted provided that their equivalence has been demonstrated.

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This document gives technical requirements and guidance on the establishment or revision of standardized reference methods used for the analysis of microorganisms in: — 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. This document specifies the technical stages of the establishment of a new standardized reference method and of the revision of an existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method. This document is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding structure at CEN level, which is CEN/TC 463.

  • Standard
    13 pages
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    13 pages
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This document specifies the minimum requirements for quality control of microbiological culture media and diluents in order to demonstrate their ability to detect microorganisms and to ensure reliability of the microbiological test methods described in the ISO cosmetics microbiology standards.
This document describes mainly growth promotion and microbial control tests and is applicable to both commercially ready-to-use culture media and culture media prepared from dehydrated culture media or basic constituents in the user’s laboratory.
Other methods can be substituted provided that their equivalence has been demonstrated.

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This document specifies the minimum requirements for quality control of microbiological culture media and diluents in order to demonstrate their ability to detect microorganisms and to ensure reliability of the microbiological test methods described in the ISO cosmetics microbiology standards. This document describes mainly growth promotion and microbial control tests and is applicable to both commercially ready-to-use culture media and culture media prepared from dehydrated culture media or basic constituents in the user’s laboratory. Other methods can be substituted provided that their equivalence has been demonstrated.

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Refers to taper dimensions and tolerances for electrode caps, electrode adaptors, electrode holders and similar parts, where the electrode force Fmax, given for diameter d1 in tables 1, 2 and 3 is not exceeded. Establishes dimensions, designation and marking. Cancels and replaces ISO Recommendation R 1089-1969, of which it constitutes a technical revision.

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

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This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.

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

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This International Standard specifies requirements for the evaluation of membrane filters intended for the concentration for direct enumeration of specific microorganisms and mixed populations. These requirements are applicable to all membrane filters intended for the microbiological analysis of all kinds of water and other liquid samples.
These requirements are intended for the test to demonstrate the suitability of the whole system - membrane filter together with culture medium including the filtration step - required for specific tests described in International Standards.
The membrane filters required for use are described in each specific standard. This International Standard applies to producers and users such as:
— commercial bodies producing and/or distributing membrane filters;
— non-commercial bodies supplying membrane filters to third parties;
— microbiological laboratories using membrane filters for their own testing or providing these to other users.

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This method describes a procedure for the qualitative detection of hazelnut (Corylus avellana) in
chocolate. DNA is extracted from the chocolate and a specific DNA sequence for hazelnut
detected from the gene for corA 1.

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This document specifies the detection of Clostridium perfringens. This part of ISO 15213 is applicable to:
• products intended for human consumption;
• products intended for animal feeding;
• environmental samples in the area of food and feed production, handling, and
• samples from the primary production stage.
This method is applicable when the number sought is expected to be below 100 per ml or per g of the test sample.

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This method describes a procedure for the qualitative detection of peanut (Arachis hypogaea) in
chocolate using real-time PCR based on the gene for the peanut allergen Ara h 2 [4, 5].

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This method specifies a procedure for the qualitative detection of species specific DNA from
white mustard (Sinapis alba) and soya (Glycine max) in cooked sausages using singleplex realtime
PCR based on the genes MADS-D (mustard) and lectin (soya). A mustard content of 10
mg/kg or greater and a soya content of 10 mg/kg or greater can be detected with a probability of
> 95 %.

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