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EVS-EN ISO 16140-2:2016+A1:2024

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method (ISO 16140-2:2016 + ISO 16140-2:2016/Amd 1:2024)

General information

Valid from 15.10.2024
Base Documents
ISO 16140-2:2016; EN ISO 16140-2:2016; ISO 16140-2:2016/Amd 1:2024; EN ISO 16140-2:2016/A1:2024
ICS Groups
07.100.30 Food microbiology
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.10.2024
Main + amendment
EVS-EN ISO 16140-2:2016+A1:2024
01.10.2024
Amendment
EVS-EN ISO 16140-2:2016/A1:2024
03.08.2016
Main
EVS-EN ISO 16140-2:2016
This part of ISO 16140 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to this part of ISO 16140 are intended to be performed by organizations involved in method validation.
This part of ISO 16140 is applicable to the validation of methods 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, and
—  samples from the primary production stage.
This part of ISO 16140 is in particular applicable to bacteria and fungi. Some clauses of this part of ISO 16140 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in either this part or a separate part of ISO 16140.

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EVS-EN ISO 16140-3:2021

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English