Animal feeding stuffs: Methods of sampling and analysis - Recommendations for the organization and evaluation of collaborative studies for multi-analyte methods of analysis

This document gives guidance to those involved in designing, executing and evaluating interlaboratory comparison studies for multi-analyte methods of analysis, developed by CEN/TC 327 “Animal feeding stuffs: Methods of sampling and analysis” and its working groups.
For the validation of multi-analyte methods their particularities must be considered which might necessitate deviations from the prescribed validation protocols. This study provides information whether the method is fit for its purpose and which performance can be expected in practical work while at the same time keeping the necessary effort for the study organizer and the participating laboratories minimal.
Next to the abovementioned aspects regarding interlaboratory comparison studies, this document also gives guidance on the preceding steps, viz. in-house validation and preparation of the method protocol. Guidance is also given on the transferability of the method protocol and the familiarization with the method protocol through a training study, elements that – depending on the specific method – could be included in the design of the study.

Futtermittel: Probenahme- und Untersuchungsverfahren - Empfehlungen für das Organisieren und die Auswertung von Ringversuchen für Multi-Analyt-Untersuchungsverfahren

Dieses Dokument enthält eine Anleitung für Organisatoren von Studien, die an der Konzeption, Durchführung und Auswertung von Ringversuchen für Multi Analyt Verfahren beteiligt sind, die von den verschiedenen Arbeitsgruppen des CEN/TC 327 „Futtermittel — Probenahme  und Untersuchungs¬verfahren“ entwickelt wurden. Das Hauptziel solcher Studien ist es, die Vergleichstandardabweichungen für die in den ausgewählten Matrices untersuchten Analyte zu bestimmen. Diese werden aus der Wiederholpräzision und den aus den Versuchsdaten ermittelten Standardabweichungen zwischen den Laboratorien berechnet. Ein weiteres Ziel kann die Bestimmung der Richtigkeit sein (wo immer möglich).

Aliments pour animaux : Méthodes d’échantillonnage et d'analyse - Recommandations pour l’organisation et l’évaluation des études comparatives interlaboratoires utilisant des méthodes d'analyses multianalytes

Le présent document fournit des recommandations à l’attention des organisateurs d’études impliqués dans la conception, l’exécution et l’évaluation d’études comparatives interlaboratoires pour des méthodes multianalytes développées par les divers groupes de travail du CEN/TC 327 « Aliments des animaux : Méthodes d’échantillonnage et d’analyse ». Le principal objectif de ces études est de déterminer les écarts-types de reproductibilité pour les analytes examinés dans les matrices sélectionnées. Ils sont calculés à partir de la répétabilité et des écarts-types entre laboratoires, déterminés à partir des données de l’étude. Un but supplémentaire peut être la détermination de la justesse (lorsque c’est possible).

Krma: metode vzorčenja in analize - Priporočila za organizacijo in vrednotenje medlaboratorijskih primerjalnih shem za multirezidualne analizne metode

Ta dokument podaja napotke vsem, ki sodelujejo pri načrtovanju, izvajanju in vrednotenju medlaboratorijskih primerjalnih shem za multirezidualne analizne metode, ki jih je razvil odbor CEN/TC 327 »Krma za živali: metode za vzorčenje in analizo« ter njegove delovne skupine.
Za validacijo multirezidualnih analiznih metod je treba upoštevati njihove posebnosti, ki bi lahko zahtevale odstopanja od predpisanih validacijskih protokolov. Ta shema podaja informacije, ali je metoda primerna za njen namen in kakšno učinkovitost je mogoče pričakovati pri praktičnem delu, hkrati pa zagotavlja, da so potrebni napori organizatorja sheme in sodelujočih laboratorijev minimalni.
Ta dokument poleg zgoraj omenjenih vidikov medlaboratorijskih primerjalnih shem daje tudi smernice za predhodne korake, tj. interno potrjevanje in pripravo protokola metode. Podane so tudi smernice za prenosljivost protokola metode in seznanjanje s protokolom metode s pomočjo sheme o usposabljanju, elementih, ki bi (odvisno od metode) lahko bili vključeni v zasnovo sheme.

General Information

Status
Published
Publication Date
24-Sep-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
25-Sep-2019
Due Date
30-Nov-2019
Completion Date
25-Sep-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 17421:2019
01-december-2019
Krma: metode vzorčenja in analize - Priporočila za organizacijo in vrednotenje
medlaboratorijskih primerjalnih shem za multirezidualne analizne metode
Animal feeding stuffs: Methods of sampling and analysis - Recommendations for the
organization and evaluation of collaborative studies for multi-analyte methods of analysis
Futtermittel - Probenahme- und Untersuchungsverfahren - Ringversuchsvorgaben für
Multi-Analyt-Untersuchungsverfahren
Aliments pour animaux : Méthodes d’échantillonnage et d'analyse - Recommandations
pour l’organisation et l’évaluation des études comparatives interlaboratoires utilisant des
méthodes d'analyses multianalytes
Ta slovenski standard je istoveten z: CEN/TR 17421:2019
ICS:
65.120 Krmila Animal feeding stuffs
SIST-TP CEN/TR 17421:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 17421:2019

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SIST-TP CEN/TR 17421:2019


CEN/TR 17421
TECHNICAL REPORT

RAPPORT TECHNIQUE

September 2019
TECHNISCHER BERICHT
ICS 65.120
English Version

Animal feeding stuffs: Methods of sampling and analysis -
Recommendations for the organization and evaluation of
collaborative studies for multi-analyte methods of analysis
Aliments pour animaux : Méthodes d'échantillonnage Futtermittel - Probenahme- und
et d'analyse - Recommandations pour l'organisation et Untersuchungsverfahren - Ringversuchsvorgaben für
l'évaluation des études comparatives interlaboratoires Multi-Analyt-Untersuchungsverfahren; Deutsche und
utilisant des méthodes d'analyses multianalytes Englische Fassung prEN 00327126:2018


This Technical Report was approved by CEN on 9 September 2019. It has been drawn up by the Technical Committee CEN/TC
327.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 17421:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST-TP CEN/TR 17421:2019
CEN/TR 17421:2019 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Prerequisites to a collaborative study . 5
5 Design of the collaborative study . 6
6 Data collection, evaluation and interpretation . 9
7 Final collaborative study report . 10
8 Implementation of the results of the validation study in the standard . 11
Bibliography . 12
2

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SIST-TP CEN/TR 17421:2019
CEN/TR 17421:2019 (E)
European foreword
This document (CEN/TR 17421:2019) has been prepared by Technical Committee CEN/TC 327 “Animal
feeding stuffs: Methods of sampling and analysis”, the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2020
...

SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 17421:2019
01-julij-2019
Krma: metode vzorčenja in analize - Priporočila za organizacijo in vrednotenje
medlaboratorijskih študij večanalitskih metod za analizo
Animal feeding stuffs: Methods of sampling and analysis - Recommendations for the
organization and evaluation of collaborative studies for multi-analyte methods of analysis
Futtermittel - Probenahme- und Untersuchungsverfahren - Ringversuchsvorgaben für
Multi-Analyt-Untersuchungsverfahren; Deutsche und Englische Fassung prEN
00327126:2018
Aliments pour animaux : Méthodes d’échantillonnage et d'analyse - Recommandations
pour l’organisation et l’évaluation des études comparatives interlaboratoires utilisant des
méthodes d'analyses multianalytes
Ta slovenski standard je istoveten z: FprCEN/TR 17421
ICS:
65.120 Krmila Animal feeding stuffs
kSIST-TP FprCEN/TR 17421:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

kSIST-TP FprCEN/TR 17421:2019

---------------------- Page: 2 ----------------------

kSIST-TP FprCEN/TR 17421:2019


FINAL DRAFT
TECHNICAL REPORT
FprCEN/TR 17421
RAPPORT TECHNIQUE

TECHNISCHER BERICHT

May 2019
ICS
English Version

Animal feeding stuffs: Methods of sampling and analysis -
Recommendations for the organization and evaluation of
collaborative studies for multi-analyte methods of analysis
Aliments pour animaux : Méthodes d'échantillonnage Futtermittel - Probenahme- und
et d'analyse - Recommandations pour l'organisation et Untersuchungsverfahren - Ringversuchsvorgaben
l'évaluation des études comparatives interlaboratoires fÃ1/4r Multi-Analyt-Untersuchungsverfahren;
utilisant des méthodes d'analyses multianalytes Deutsche und Englische Fassung prEN 00327126:2018


This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC
327.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.

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.

Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a Technical Report.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 17421:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

kSIST-TP FprCEN/TR 17421:2019
FprCEN/TR 17421:2019 (E)
Contents Page

European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Prerequisites to a collaborative study . 5
4.1 General . 5
4.2 Performance characteristics from single-laboratory validation . 5
4.3 Standard operating procedure . 6
5 Design of the collaborative study . 6
5.1 Test materials .
...

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