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07 LOODUS- JA RAKENDUSTEADUSED
Uued standardid
EVS-EN ISO 16140-4:2020+A1:2024
Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020 + ISO 16140-4:2020/Amd 1:2024)
Käsitlusala:
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.
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.
Alusdokumendid:
ISO 16140-4:2020; EN ISO 16140-4:2020; ISO 16140-4:2020/Amd 1:2024; EN ISO 16140-4:2020/A1:2024
ISO 4962:2024
Nanotechnologies — In vitro acute nanoparticle phototoxicity assay
Käsitlusala:
This document specifies a procedure to evaluate acute phototoxicity of nanoparticles (NPs), suspended in cell culture media, by measuring the relative reduction in cellular viability under near ultraviolet (UVA) exposure (315 nm to 400 nm).
The measurement is intended to assess the potential for acute phototoxicity of NPs by comparing NP photoactivity in vitro to a positive control chlorpromazine. It is not designed to predict other joint effects of nanomaterials and light, such as genotoxicity, photo-allergy or photo-mutagenicity. The method is also applicable to NP aggregates and agglomerates.
The measurement is intended to assess the potential for acute phototoxicity of NPs by comparing NP photoactivity in vitro to a positive control chlorpromazine. It is not designed to predict other joint effects of nanomaterials and light, such as genotoxicity, photo-allergy or photo-mutagenicity. The method is also applicable to NP aggregates and agglomerates.
Alusdokumendid:
ISO 16140-7:2024
Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms
Käsitlusala:
This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.
This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:
— the reference method;
— an alternative method validated in accordance with ISO 16140-2;
— an alternative method validated in accordance with ISO 16140-6.
In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.
This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.
This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage.
Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:
— the reference method;
— an alternative method validated in accordance with ISO 16140-2;
— an alternative method validated in accordance with ISO 16140-6.
In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.
This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.
Alusdokumendid: