This document specifies requirements for the installation, maintenance, temperature calibration
and temperature performance testing of standard thermal cyclers and real-time thermal cyclers. It is
applicable to the detection of microorganisms as well as any other applications in the food chain using
polymerase chain reaction (PCR)-based methods.
This document has been established for food testing, but is also applicable to other domains using
thermal cyclers (e.g. environmental, human health, animal health, forensic testing).

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

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This document specifies requirements for the installation, maintenance, temperature calibration and temperature performance testing of standard thermal cyclers and real-time thermal cyclers. It is applicable to the detection of microorganisms as well as any other applications in the food chain using polymerase chain reaction (PCR)-based methods. This document has been established for food testing, but is also applicable to other domains using thermal cyclers (e.g. environmental, human health, animal health, forensic testing).

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This document specifies a horizontal method for the enumeration of coagulase-positive staphylococci
by counting the colonies obtained on a solid medium (Baird-Parker medium)[10]
after aerobic incubation
at 34 °C to 38 °C and coagulase confirmation.
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, handling, and
— samples from the primary production stage.
This horizontal method was originally developed for the examination of all samples belonging to the
food chain.
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.
Based on the information available at the time of publication of this document, this method is not
considered to be (fully) suited to the examination of fermented products or other products containing
technological flora based on Staphylococcus spp (e.g. S. xylosus) (such as cheeses made from raw milk
and certain raw meat products) likely to be contaminated by:
— staphylococci forming atypical colonies on a Baird-Parker agar medium;
— background flora that can obscure the colonies being sought.
Nevertheless, both this document and ISO 6888-2 are given equivalent status.

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This document specifies a horizontal method for the enumeration of coagulase-positive staphylococci
by counting the colonies obtained on a solid medium (rabbit plasma fibrinogen agar medium) after
aerobic incubation at 34 °C to 38 °C (see Reference [10]).
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.
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.
Based on the information available at the time of publication of this document, this method is not
considered to be (fully) suited to the examination of fermented products or other products containing
technological flora based on Staphylococcus spp. (e.g. S. xylosus) (such as cheeses made from raw milk
and certain raw meat products) likely to be contaminated by:
— staphylococci forming atypical colonies on a Baird-Parker agar medium;
— background flora that can obscure the colonies being sought.
Nevertheless, both ISO 6888-1 and this document are given equivalent status

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This document specifies a horizontal method for the enumeration of coagulase-positive staphylococci by counting the colonies obtained on a solid medium (rabbit plasma fibrinogen agar medium) after aerobic incubation at 34 °C to 38 °C (see Reference [10]). 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. 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. Based on the information available at the time of publication of this document, this method is not considered to be (fully) suited to the examination of fermented products or other products containing technological flora based on Staphylococcus spp. (e.g. S. xylosus) (such as cheeses made from raw milk and certain raw meat products) likely to be contaminated by: —   staphylococci forming atypical colonies on a Baird-Parker agar medium; —   background flora that can obscure the colonies being sought. Nevertheless, both ISO 6888-1 and this document are given equivalent status.

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This document specifies a horizontal method for the enumeration of coagulase-positive staphylococci by counting the colonies obtained on a solid medium (Baird-Parker medium)[10] after aerobic incubation at 34 °C to 38 °C and coagulase confirmation. 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, handling, and —   samples from the primary production stage. This horizontal method was originally developed for the examination of all samples belonging to the food chain. 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. Based on the information available at the time of publication of this document, this method is not considered to be (fully) suited to the examination of fermented products or other products containing technological flora based on Staphylococcus spp (e.g. S. xylosus) (such as cheeses made from raw milk and certain raw meat products) likely to be contaminated by: —   staphylococci forming atypical colonies on a Baird-Parker agar medium; —   background flora that can obscure the colonies being sought. Nevertheless, both this document and ISO 6888-2 are given equivalent status.

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

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This part of ISO 23036 specifies a method that is applicable for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method can be applied to fresh fish and/or frozen fish, lightly processed fish products, such as marinated, salted or smoked, and it’s also suitable for visceral organs as confirmatory method for visual inspection scheme.
The artificial digestion method allows quantifying parasitic infections by estimating the number of parasites in the fish musculature and, when applied to fresh fish or lightly processed fish products (never frozen before processing), determining the viability of Anisakidae L3, which may be present.
This method doesn’t allow determining species or genotype of detected parasites, which identification is made by morphological and/or molecular methods.

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This part of ISO 23036 specifies a method that is applicable for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method can be applied to fresh fish and/or frozen fish, lightly processed fish products, such as marinated, salted or cold smoked.
This method allows quantifying parasitic infections by estimating the number of parasites in the fish musculature.
This method doesn’t allow determining species or genotype of detected parasites, which identification
is made by morphological and/or molecular methods

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

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This document gives guidelines for the establishment of a conversion relationship between the results
of an alternative method and an anchor method, and its verification for the quantitative determination
of the microbiological quality of milk.
NOTE The conversion relationship can be used a) to convert results from an alternative method to the anchor
basis or b) to convert results/limits, expressed on an anchor basis, to results in units of an alternative method.

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This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or cold smoked. This method is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature. This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

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This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or smoked. It is also suitable for visceral organs as a confirmatory method for a visual inspection scheme. The artificial digestion method[4][5][6] is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature and, when applied to fresh fish or lightly processed fish products (never frozen before processing), determining the viability of Anisakidae L3, which can be present. This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

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1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

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This document deals with verification of methods for the detection and/or the enumeration of microorganisms, with particular emphasis on the implementation of a reference/alternative method in the user laboratory and verification of a reference/alternative method using items included in the scope of the method and tested routinely but not tested in the original validation study

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This document gives guidelines for the establishment of a conversion relationship between the results of an alternative method and an anchor method, and its verification for the quantitative determination of the microbiological quality of milk. NOTE The conversion relationship can be used a) to convert results from an alternative method to the anchor basis or b) to convert results/limits, expressed on an anchor basis, to results in units of an alternative method.

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This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory. This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing of microorganisms in: — products intended for human consumption; — products intended for animal feeding; — environmental samples in the area of food and feed production, handling; — samples from the primary production stage. This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis. The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.

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This standard specifies a method for the determination of the microbiological resistance of geotextiles and geotextile-related products by a soil burial test. It does not specify for which products or in which applications the soil burial test is required. Further reference should be made to CR ISO 13434.

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This document specifies a method for the direct enumeration of potentially enteropathogenic V. parahaemolyticus (tdh and/or trh positive) and/or the enumeration of total V. parahaemolyticus in seafood.

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The proposed deliverable specifies the procedure for single-laboratory validation of mainly non-proprietary methods in the fields of microbiological analysis of food, feed, and environmental and primary production stage samples. Single-laboratory validation is required if an interlaboratory validation according to ISO 16140-2 is not appropriate, e.g. for in-house methods or when the required number of participating laboratories is not available. Single-laboratory validation is not part of the optimization of methods. It can be applied only for methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on nutrient media).
The proposed deliverable describes two protocols for single-laboratory validation, a conventional protocol, and a factorial protocol. The conventional protocol is a stepwise procedure; both the study design and the performance measures are derived from ISO 16140-2. The performance measures of the factorial protocol are also derived from ISO 16140-2; however, it is using an orthogonal, factorial study design. By selection of suitable influencing factors (technician, nutrient media, sample preparation, temperature, duration) a high certainty of the determined method validation parameters is obtained, so that the number of required individual tests can be reduced by more than 50 %.

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The proposed deliverable specifies an alternative technical protocol for the validation of mostly non-proprietary methods in the field of microbiological analysis of food, animal feed, and environmental and primary production stage samples.
It is closely related to ISO 16140-2. The latter specifies the technical protocol for the validation of proprietary methods, including a classical interlaboratory study and a method comparison study to be conducted in one laboratory. The realization of classical interlaboratory studies demands a sufficient number of participating laboratories (at least 8 laboratories are required). There are many occasions where a sufficient number of participating laboratories is not available (e.g. when a new method is required quickly after an outbreak of a new microorganism). In this case, the validation cannot be considered as reliable any longer.
The proposed deliverable uses a modified protocol based on orthogonal, factorial studies. By selection of suitable influencing factors (technician, nutrient media, sample preparation, temperature, duration) a high certainty of the determined method validation parameters is obtained, so that the number of required collaborating laboratories can be reduced up to a minimum of 4.
This validation protocol can be used in different ways. If the 4 collaborators can be considered a “random sample” of independent and competent laboratories and from different organizations, the test method can be considered as being validated in the sense that accurate and precise measurements are to be expected from any competent laboratory. If the 4 collaborators can be considered a “random sample” of independent and competent laboratories from one organization, the test method can be considered as being validated in the sense that accurate and precise measurements are to be expected from any competent laboratory in this organization.

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This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.

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This document specifies the general principles and the technical protocols (based on orthogonal, factorial studies) for the validation of non-proprietary methods for microbiology of the food chain. This document is applicable to the validation of methods used for the analysis (detection or quantification) of microorganisms in: — products intended for human consumption; — products intended for animal feeding; — environmental samples in the area of food and feed production, handling; — samples from the primary production stage. This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis. This document specifies protocols for the validation against a reference method for both quantitative and qualitative methods. This document also provides a protocol for the validation of quantitative methods without a reference method. Qualitative methods cannot be validated without a reference method in accordance with this document. NOTE ISO 16140-2 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods against a reference method. This document is only applicable to the validation of methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized. Methods that have been validated in accordance with this document can be used by the laboratories of the specified population of laboratories.

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This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study. This document is applicable to single-laboratory validation of: — methods used in the analysis (detection or quantification) of microorganisms in: — products intended for human consumption; — products intended for animal feeding; — environmental samples in the area of food and feed production, handling; — samples from the primary production stage; — methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G). This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis. Single-laboratory validation is required if an interlaboratory validation in accordance with ISO 16140-2 is not appropriate. Possible applications are: — validation of an in-house method; — method evaluation study in the validation process of a reference method in accordance with ISO 17468; — extension of the scope of an ISO 16140-2 validated method, e.g. category extension or test portion size; — modifications of existing methods. Single-laboratory validation is the second step in the standardization of a reference method (see ISO 17468). It is only applicable to methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.

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This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing. The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.

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This document specifies rules for the preparation of samples of milk and milk products and their
suspensions for microbiological examination when the samples require a different preparation from
the general methods specified in ISO 6887-1.
This document excludes the preparation of samples for both enumeration and detection test methods
where preparation details are specified in the relevant International Standards.
This document is intended to be used in conjunction with ISO 6887-1.
This document is applicable to:
a) milk and liquid milk products;
b) dehydrated milk products;
c) cheese and cheese products;
d) casein and caseinates;
e) butter;
f) milk-based ice-cream;
g) milk-based custard, desserts and sweet cream;
h) fermented milks, yogurt, probiotics milk products and sour cream;
i) dehydrated milk-based infant foods, with or without probiotics.

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EN-ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products.

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This document specifies rules for the preparation of samples of milk and milk products and their suspensions for microbiological examination when the samples require a different preparation from the general methods specified in ISO 6887-1. This document excludes the preparation of samples for both enumeration and detection test methods where preparation details are specified in the relevant International Standards. This document is intended to be used in conjunction with ISO 6887-1. This document is applicable to: a) milk and liquid milk products; b) dehydrated milk products; c) cheese and cheese products; d) casein and caseinates; e) butter; f) milk-based ice-cream; g) milk-based custard, desserts and sweet cream; h) fermented milks, yogurt, probiotics milk products and sour cream; i) dehydrated milk-based infant foods, with or without probiotics.

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This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, confirmation methods in the field of microbiological analysis of food, animal feed, and environmental and primary production stage samples. This procedure is limited to the validation of alternative (proprietary) confirmation methods that are intended to replace (partly or completely) the confirmatory procedure described in the standard method for the enumeration or detection of specific (group of) microorganisms. The "sample" to be used for confirmation shall be a suspected colony that has been obtained following the reference or alternative culture method procedure. It is however not intended for confirmation using a (pure) colony from an unknown origin. Validation studies according to this standard are intended to be performed by organizations involved in method validation.

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This standard specifies a method for the detection, semi-quantitative and quantitative (MPN) enumeration of thermotolerant Campylobacter species. The method can be applied to all kinds of waters including: drinking water, ground water and well water, fresh, brackish and saline surface water, swimming pools, spa and hydrotherapy pools, recreational waters, agricultural waters and runoff, untreated and treated wastewater and also sand and other sediments. This method can be used for the detection of Campylobacter species in a specified sample volume. Clean water samples with low turbidity can be membrane filtered for either a qualitative method, semiquantitative or quantitative (MPN) method. Water samples with higher turbidity, such as primary and secondary wastewater effluents and sediments, are analysed using the same qualitative, semiquantitative or quantitative MPN method by direct inoculation of material into bottles or tubes. Sediments can be suspended in a suitable diluent or inoculated directly into enrichment broths. Users wishing to employ this method are expected to verify its performance for the particular matrix under their own laboratory conditions.

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This International Standard gives requirements and guidance for the estimation and expression of measurement
uncertainty (MU) associated with quantitative results in microbiology of the food chain.
It is applicable to the quantitative analysis
 of products intended for human consumption or the feeding of animals, and
 of environmental samples in the area of food production and food handling,
 of samples at the stage of primary production.
The quantitative analysis is typically carried out by enumeration of microorganisms using a colony-count technique. It is
also generally applicable to other quantitative analyses, including Most Probable Number (MPN) techniques and
instrumental methods.
The uncertainty estimated by this International Standard does not include systematic effects (“trueness” or “bias”).

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This document specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e.g. whole genome sequencing).
This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated microorganisms in:
—          products intended for human consumption;
—          products intended for animal feeding;
—          environmental samples in the area of food and feed production, handling;
—          samples from the primary production stage.
Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:
—          the reference method;
—          an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars specified in the validation study of the alternative confirmation method is used.
This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case basis.
Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4).

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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

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