Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines Referenzverfahrens

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2: Protocole pour la validation de méthodes alternatives (commerciales) par rapport à une méthode de référence

Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za validacijo alternativnih (lastniških) metod glede na referenčno metodo - Dopolnilo A1

General Information

Status
Not Published
Publication Date
23-Sep-2024
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Start Date
06-Mar-2024
Completion Date
06-Mar-2024

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EN ISO 16140-2:2016/oprA1:2023
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16140-2:2016/oprA1:2023
01-oktober-2023
Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za
validacijo alternativnih (lastniških) metod glede na referenčno metodo - Dopolnilo
A1
Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of
alternative (proprietary) methods against a reference method
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für
die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines
Referenzverfahrens
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2: Protocole
pour la validation de méthodes alternatives (commerciales) par rapport à une méthode
de référence
Ta slovenski standard je istoveten z: EN ISO 16140-2:2016/prA1
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140-2:2016/oprA1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16140-2:2016/oprA1:2023

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SIST EN ISO 16140-2:2016/oprA1:2023
DRAFT AMENDMENT
ISO 16140-2:2016/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-07-18 2023-10-10
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
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 16140-2:2016/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
DRAFT AMENDMENT
ISO 16140-2:2016/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:

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
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO 16140-2:2016/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The wor
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