DIN Standards Committee Food and Agricultural Products
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/FDAM 1:2024); German and English version EN ISO 16140-2:2016/FprA1:2024
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 057-01-12 AA - Validation of microbiological methods
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
