BS EN ISO 16140-6:2019 - Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

BS EN ISO 16140-6:2019

Microbiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

Status : Current   Published : December 2019

Format
PDF

Format
HARDCOPY



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).




Standard NumberBS EN ISO 16140-6:2019
TitleMicrobiology of the food chain. Method validation. Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
StatusCurrent
Publication Date17 December 2019
Normative References(Required to achieve compliance to this standard)ISO 16140-1:2016
Informative References(Provided for Information)ISO 17468:2016, ISO/TR 6579-3, ISO 16140-3, ISO 21528-2, ISO 16140-2, ISO 16140-4, ISO 16140-5, ISO 11290, ISO 6579-1, ISO 11133
International RelationshipsISO 16140-6:2019,EN ISO 16140-6:2019
DescriptorsFungi, Bacteria, Fit for human consumption (food), Vocabulary, Microbiological analysis, Microbiology
ICS07.100.30
Title in FrenchMicrobiologie de la chaîne alimentaire. Validation des méthodes Protocole pour la validation de méthodes alternatives (commerciales) pour la confirmation microbiologique et le typage
Title in GermanMikrobiologie der Lebensmittelkette. Verfahrensvalidierung Arbeitsvorschrift für die Validierung (urheberrechtlich geschützter) Alternativverfahren für die Bestätigungs- und Typisierungsprüfung
CommitteeAW/9
ISBN978 0 580 89056 7
PublisherBSI
FormatA4
DeliveryYes
Pages36
File Size1.727 MB
Price£214.00


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