2. Getting involved
3. Standards Committees
4. NAL

DIN Standards Committee Food and Agricultural Products

Abstract

This document contains the working procedure used in method validation for the validation of alternative (proprietary) methods against a reference method. Amendment 1 includes a revision of the introduction, the data evaluation of the qualitative method comparison test and the calculation of the relative detection limit. It also adds a new annex on the testing of methods for sterilization.

Begin

2021-06-28

WI

00463098

Planned document number

DIN EN ISO 16140-2/A1

Project number

05702537

Responsible national committee

NA 057-01-06 AA - Microbiology of the food chain  

Responsible european committee

CEN/TC 463 - Microbiology of the food chain  

Responsible international committee

ISO/TC 34/SC 9/WG 3 - Method validation  

draft standard

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - AMENDMENT 1: Revision of qualitative MCS data evaluation, RLOD calculations in the ILS, calculation and interpretation of the RT study, and inclusion of a commercial sterility testing protocol for specific products (ISO 16140-2:2016/DAM 1:2023); German and English version EN ISO 16140-2:2016/prA1:2023
2023-08
Order from DIN Media

previous edition(s)

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); German version EN ISO 16140-2:2016
2016-11