CEN/TR 15356-1:2006

Validation and interpretation of analytical methods, migration testing and analytical data for materials and articles in contact with food - Part 1: General considerations

This Technical Report gives guidance in support of Directives adopted by the European Union in the Food Contact Materials Sector and is intended to aid Food Control Authorities and industry enforce and comply with those Directives.

Validierung und Interpretation analytischer Verfahren, Migrationsprüfung und analytischer Daten von Werkstoffen und Bedarfsgegenständen in Kontakt mit Lebensmitteln - Teil 1: Allgemeine Betrachtungen

Validation et interprétation des méthodes d'analyse, essais de migrations et données analytiques des matériaux et objets en contact avec les denrées alimentaires - Partie 1 : Considérations générales

Validacija in interpretacija analitskih metod, migracijsko preskušanje in analitski podatki za materiale in predmete v stiku z živili – 1. del: Splošne ugotovitve

General Information

• Status: Published
• Publication Date: 14-Mar-2006
• ICS: 13.060.20 - Drinking water
• ICS: 23.060.50 - Check valves
• Technical Committee: CEN/TC 194 - Utensils in contact with food
• Drafting Committee: CEN/TC 194/SC 1 - General chemical methods of test for materials and articles intended to come into contact with foods
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Mar-2006
• Due Date: 21-Jun-2006
• Completion Date: 15-Mar-2006
• Ref Project: SIST-TP CEN/TR 15356-1:2006 - Validation and interpretation of analytical methods, migration testing and analytical data for materials and articles in contact with food - Part 1: General considerations

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 15356-1:2006
01-september-2006
Validacija in interpretacija analitskih metod, migracijsko preskušanje in analitski
podatki za materiale in predmete v stiku z živili – 1. del: Splošne ugotovitve
Validation and interpretation of analytical methods, migration testing and analytical data
for materials and articles in contact with food - Part 1: General considerations
Validierung und Interpretation analytischer Verfahren, Migrationsprüfung und
analytischer Daten von Werkstoffen und Bedarfsgegenständen in Kontakt mit
Lebensmitteln - Teil 1: Allgemeine Betrachtungen
Validation et interprétation des méthodes d'analyse, essais de migrations et données
analytiques des matériaux et objets en contact avec les denrées alimentaires - Partie 1 :
Considérations générales
Ta slovenski standard je istoveten z: CEN/TR 15356-1:2006
ICS:
67.250
SIST-TP CEN/TR 15356-1:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

TECHNICAL REPORT
CEN/TR 15356-1
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
March 2006
ICS 13.060.20; 23.060.50

English Version
Validation and interpretation of analytical methods, migration
testing and analytical data for materials and articles in contact
with food - Part 1: General considerations
Validation et interprétation des méthodes d'analyse, essais Validierung und Interpretation analytischer Verfahren,
de migrations et données analytiques des matériaux et Migrationsprüfung und analytischer Daten von Werkstoffen
objets en contact avec les denrées alimentaires - Partie 1 : und Bedarfsgegenständen in Kontakt mit Lebensmitteln -
Considérations générales Teil 1: Allgemeine Betrachtungen
This Technical Report was approved by CEN on 16 January 2006. It has been drawn up by the Technical Committee CEN/TC 194.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15356-1:2006: E
worldwide for CEN national Members.

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

CEN/TR 15356-1:2006 (E)
Contents Page
Foreword. 3
Introduction . 4
1 Scope. 6
2 Form of regulations . 6
3 Terms and definitions. 7
4 Analytical tolerances . 10
5 Limits. 12
6 Existing general legislation . 14
7 Difficulties with present situation regarding method validation. 17
8 Analytical interpretation of results and limits. 19
9 Single laboratory method validation - General protocol. 23
10 Single laboratory and second laboratory validation - For the food contact
materials sector. 23
11 FDA requirements with respect to validation of analytical methods . 25
12 Recovery . 25
13 Reference materials. 27
14 Costs .
...