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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    • Technical specification
      13 pages
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      13 pages
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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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    • Standard
      84 pages
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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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    • Standard
      19 pages
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    • Standard
      19 pages
      French language
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    • Draft
      19 pages
      English language
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    • Draft
      19 pages
      French language

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 prima...view more

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    • Standard
      70 pages
      English language
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    • Standard
      80 pages
      French language
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    • Draft
      69 pages
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    • Draft
      79 pages
      French language

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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    • Standard
      8 pages
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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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    • Technical specification
      27 pages
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      27 pages
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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 class...
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    • Standard
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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 op...view more

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    • Standard
      57 pages
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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, et...
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    • Standard
      32 pages
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    • Standard
      26 pages
      English language
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    • Standard
      26 pages
      French language

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 sa...view more

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    • Standard
      46 pages
      English language
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    • Standard
      46 pages
      English language
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    • Standard
      49 pages
      French language
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    • Standard
      49 pages
      French language

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 fro...view more

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    • Standard
      34 pages
      English language
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    • Standard
      34 pages
      English language
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    • Standard
      38 pages
      French language
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    • Standard
      38 pages
      French language
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    • Amendment
      19 pages
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    • Amendment
      16 pages
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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 d...
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    • Standard
      18 pages
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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...view more

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    • Standard
      32 pages
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    • Standard
      26 pages
      English language
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    • Standard
      26 pages
      French language

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, ...view more

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    • Standard
      35 pages
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    • Standard
      13 pages
      English language
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    • Standard
      13 pages
      English language
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    • Standard
      14 pages
      French language
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    • Standard
      14 pages
      French language

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 documen...view more

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    • Standard
      11 pages
      English language
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    • Standard
      11 pages
      French language
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    • Standard
      27 pages
      English language
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    • Standard
      27 pages
      English language
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    • Standard
      27 pages
      French language
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    • Standard
      27 pages
      French language
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    • Standard
      1 page
      English language
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    • Standard
      1 page
      French language

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 enumerati...view more

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    • Standard
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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 ...view more

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    • Standard
      25 pages
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    • Standard
      30 pages
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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 o...
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    • Standard
      47 pages
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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 quantifi...
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    • Standard
      35 pages
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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 pr...view more

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    • Standard
      16 pages
      English language
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    • Standard
      18 pages
      French language

This document specifies requirements and gives 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;
— environmental samples in the area of food production and food handling;
— samples at the stage of primary production.
The quantitative analysis is typically carried out by enumerat...
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    • Standard
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This document 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 ...view more

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    • Standard
      25 pages
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    • Standard
      30 pages
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This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories. This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feed...view more

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    • Standard
      26 pages
      English language

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 quantific...view more

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    • Standard
      25 pages
      English language
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    • Standard
      26 pages
      French language

This document specifies a method for the detection of celery (Apium graveolens) in emulsion-type sausages (e.g. Frankfurter, Wiener).
Real-time PCR detection of celery is based on an 101 bp (base pair) sequence from the gene of the mannitol dehydrogenase (GenBank Acc. No. AF067082 ) of celery (Apium graveolens).
The method has been validated on emulsion-type sausages (Bavarian “Leberkäse”) spiked with celery. For this purpose meat batter containing mass fractions of 50 % pork meat, 25 % pork ...
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    • Standard
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This document provides the overall framework for detection of sequences corresponding to species containing allergens using the polymerase chain reaction (PCR). It relates to the requirements for the specific amplification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified nucleic acid sequence.
Guidelines, minimum requirements and performance criteria laid down in this document are intended to ensure that comparable and reproducible results are ob...
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    • Standard
      15 pages
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This document specifies requirements and gives 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; — environmental samples in the area of food production and food handling; — samples at the stage of primary production. The quantitative analysis is typically carried out by enumeration o...view more

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    • Standard
      38 pages
      English language
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    • Standard
      39 pages
      French language

EN-ISO 15216-2 specifies a method for detection of hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII), from test samples of foodstuffs [(soft fruit, leaf, stem and bulb vegetables, bottled water, bivalve molluscan shellfish (BMS)] or surfaces using real-time RT-PCR.This method is not validated for detection of the target viruses in other foodstuffs (including multi-component foodstuffs), or any other matrices, nor for the detection of other viruses in foodstuffs, surfaces or ot...view more

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    • Standard
      49 pages
      English language
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      1 day

This document provides the overall framework for detection of sequences corresponding to species containing allergens using the polymerase chain reaction (PCR). It relates to the requirements for the specific amplification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified nucleic acid sequence.
Guidelines, minimum requirements and performance criteria laid down in European Standards are intended to ensure that comparable and reproducible results ar...
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    • Standard
      15 pages
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This document specifies a method for the detection of celery (Apium graveolens) in emulsion-type sausages (e.g. Frankfurter, Wiener).
Real-time PCR (polymerase chain reaction) detection of celery is based on an 101 bp (base pair) sequence from the gene of the mannitol dehydrogenase (GenBank Acc. No. AF067082 ) of celery (Apium graveolens).
The method has been validated on emulsion-type sausages (Bavarian “Leberkäse”) spiked with celery. For this purpose meat batter containing mass fractions of...
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    • Standard
      20 pages
      English language
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This document specifies a method for detection of hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII), from test samples of foodstuffs [(soft fruit, leaf, stem and bulb vegetables, bottled water, bivalve molluscan shellfish (BMS)] or surfaces using real-time RT-PCR.
This method is not validated for detection of the target viruses in other foodstuffs (including multi-component foodstuffs), or any other matrices, nor for the detection of other viruses in foodstuffs, surfaces or o...
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    • Standard
      49 pages
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This European Standard specifies general requirements for the measurement of microorganisms and microbial compounds. This European Standard provides also guidelines for the assessment of workplace exposure to airborne micro-organisms including the determination of total number and culturable number of micro-organisms and microbial compounds in the workplace atmosphere.

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    • Standard
      42 pages
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This document specifies a method for the detection and quantification of Legionella spp. and
L. pneumophila using a quantitative polymerase chain reaction (qPCR). It specifies general
methodological requirements, performance evaluation requirements, and quality control requirements.
Technical details specified in this document are given for information only. Any other technical
solutions complying with the performance requirements are suitable.
NOTE 1 For performance requirements, see Claus...
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    • Technical specification
      47 pages
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    • Technical specification
      53 pages
      English language
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    • Technical specification
      53 pages
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This document specifies general requirements for the measurement of microorganisms and microbial compounds.
This document provides also guidelines for the assessment of workplace exposure to airborne microorganisms including the determination of total number and culturable number of microorganisms and microbial compounds in the workplace atmosphere.
This document does not apply to the measurement of viruses.

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    • Standard
      42 pages
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This document specifies a horizontal method for the enumeration of psychrotrophic microorganisms that are able to grow and form colonies on a solid agar culture medium after aerobic incubation at 6,5 °C. 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. NOTE Annex B specifies a rapid method for the estimated en...view more

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    • Standard
      10 pages
      English language
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    • Standard
      10 pages
      French language

This document specifies a method for detection of hepatitis A virus (HAV) and norovirus genogroups I (GI) and II (GII), from test samples of foodstuffs [(soft fruit, leaf, stem and bulb vegetables, bottled water, bivalve molluscan shellfish (BMS)] or surfaces using real-time RT-PCR. This method is not validated for detection of the target viruses in other foodstuffs (including multi-component foodstuffs), or any other matrices, nor for the detection of other viruses in foodstuffs, surfaces or ot...view more

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    • Standard
      40 pages
      English language
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    • Standard
      47 pages
      French language

This document specifies a procedure for the interpretation of data generated by the preservation
efficacy test or by the microbiological risk assessment, or both, when evaluating the overall
antimicrobial protection of a cosmetic product.
It comprises:
— a preservation efficacy test;
— a procedure for evaluating the overall antimicrobial protection of a cosmetic product that is not
considered low risk, based on a risk assessment described in ISO 29621.
The preservation efficacy test is a ...
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This document specifies protocols for conducting microbiological challenge tests for growth studies on
vegetative and spore-forming bacteria in raw materials and intermediate or end products.
The use of this document can be extended to yeasts that do not form mycelium.

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    • Standard
      37 pages
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This document specifies protocols for conducting microbiological challenge tests for growth studies on vegetative and spore-forming bacteria in raw materials and intermediate or end products.
The use of this document can be extended to yeasts that do not form mycelium.

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    • Standard
      37 pages
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This document specifies methods for determining the deterioration of plastics due to the action of fungi
and bacteria and soil microorganisms. The aim is not to determine the biodegradability of plastics or
the deterioration of natural fibre composites.
The type and extent of deterioration can be determined by
a) visual examination and/or
b) changes in mass and/or
c) changes in other physical properties.
The tests are applicable to all plastics that have an even surface and that can thus ...
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    • Standard
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