EN 12868:2017

Child use and care articles - Method for determining the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers

Tests have shown quite different results for Nitrosatables and that the tests are not reliable. The objective of the work will be to find a better way to determine Nitrosatables

Artikel für Säuglinge und Kleinkinder - Verfahren zur Bestimmung der Abgabe von N-Nitrosaminen und N-nitrosierbaren Stoffen aus Flaschen- und Beruhigungssaugern aus Elastomeren oder Gummi

Diese Europäische Norm legt die Verfahren zur Probenherstellung und Migration von Saugteilen für Babys aus Elastomer oder Gummi und zur Isolation, Identifizierung und quantitativen Bestimmung der aus Saugteilen aus Elastomeren oder Gummi freigesetzten N Nitrosamine und N-Nitrosierbaren Stoffe bei Kontakt mit künstlicher Speichelsalzlösung fest.

Articles de puériculture - Méthode pour déterminer la libération de N-nitrosamines et de substances N-nitrosables par les tétines et les sucettes en élastomère ou en caoutchouc

La présente Norme européenne spécifie les méthodes de préparation et de migration des échantillons de tétines et de sucettes en élastomère ou en caoutchouc, et d’isolation, d’identification et de quantification des N-nitrosamines et des substances N-nitrosables libérées par les tétines en élastomère ou en caoutchouc en contact avec la solution saline de salive artificielle.

Izdelki za otroke - Metode za ugotavljanje sproščanja N-nitrozaminov in N-nitrozabilnih snovi iz dud za stekleničke, tolažilnih dud, nastavkov za dojenje, grizal/žvečil in podobnih predmetov, izdelanih iz elastomerov ali gume

Preskusi so pokazali različne rezultate za nitrozabilne snovi in ti preskusi niso zanesljivi. Cilj dela bo poiskati boljši načni za določanje nitrozabilnih snovi.

General Information

• Status: Published
• Publication Date: 10-Jan-2017
• Withdrawal Date: 30-Jul-2017
• ICS: 97.190 - Equipment for children
• Technical Committee: CEN/TC 252 - Child use and care articles
• Drafting Committee: CEN/TC 252/WG 5 - Feeding, drinking, sucking and similar functions
• Current Stage: 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
• Start Date: 02-Sep-2022
• Completion Date: 02-Sep-2022
• Directive: 89/109/EEC - Materials and articles intended to come into contact with foodstuffs
• Mandate: M/052 - Standardization mandate to CEN concerning methods of analysis for materials and articles intended to come into contact with foodstuffs
• Ref Project: SIST EN 12868:2017 - Child use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers

Relations

• Replaces: EN 12868:1999/AC:2002 - Child use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers
• Effective Date: 18-Jan-2017
• Replaces: EN 12868:1999 - Child use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers
• Effective Date: 29-Apr-2009

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Artikel für Säuglinge und Kleinkinder - Verfahren zur Bestimmung der Abgabe von N-Nitrosaminen und N-Nitrosierbaren Stoffen aus Flaschen- und Beruhigungssaugern aus Elastomeren oder GummiArticles de puériculture - Méthodes pour déterminer la libération de N-nitrosamines et de substances N-nitrosables par les tétines et les sucettes en élastomère ou en caoutchoucChild use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers97.190Otroška opremaEquipment for childrenICS:Ta slovenski standard je istoveten z:EN 12868:2017SIST EN 12868:2017en,fr,de01-julij-2017SIST EN 12868:2017SLOVENSKI
STANDARDSIST EN 12868:2002/AC:2003SIST EN 12868:20021DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12868
January
t r s y ICS
{ yä s { r Supersedes EN
s t z x zã s { { {English Version
Child use and care articles æ Method for determining the release of Nænitrosamines and Nænitrosatable substances from elastomer or rubber teats and soothers Articles de puériculture æ Méthode pour déterminer la libération de Nænitrosamines et de substances Nænitrosables par les tétines et les sucettes en élastomère ou en caoutchouc
Artikel für Säuglinge und Kleinkinder æ Verfahren zur Bestimmung der Abgabe von NæNitrosaminen und Nænitrosierbaren Stoffen aus Babysaugern aus Elastomeren und Gummi This European Standard was approved by CEN on
u r October
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s t z x zã t r s y ESIST EN 12868:2017

Rationales . 23 A.1 General . 23 A.2 Migration Conditions (see 8.3.2) . 23 A.3 Nitrosation conditions (see 8.3.3) . 23 A.4 Weight of sample used (see 8.3.1) . 23 A.5 Separate migrations (see 8.3.2 and 8.3.3) . 24 A.6 Duplicate tests (see 8.1) . 24 A.7 TEA and alternative detectors . 24 A.8 Deviations (see 9.2, 9.3 and 11) . 25 A.9 Main differences between this standard and EN 71-12 [3] . 25 Annex B (informative)
Suitable gas chromatographic method . 26 Figure B.1 — GC Chromatogram of a calibration solution recorded by TEA . 27 Annex C (normative)
Example of results calculation and test report . 28 C.1 General . 28 C.2 Example for variability testing and means calculation for analytical results . 28 Table C.1 — Example for variability testing and means calculation for Sample A . 29 Table C.2 — Example for variability testing and means calculation for Sample B . 29 C.3 Results calculation and results table for test report . 30 Table C.3 — Example of Final results and their representation . 31 C.4 Other Information for test report . 31 Annex D (informative)
Alternative Methods . 32 D.1 General . 32 D.2 Liquid Chromatography (LC) . 32 Table D.1 — Gradient profile for the given HPLC conditions . 33 D.3 MS/MS conditions . 33 Table D.2 — Suitable MRM Transitions for MS/MS conditions . 34 D.4 Confirmation and quantification of detected N-nitrosamines . 34 Table D.3 — Maximum permitted tolerances for relative ion intensities . 34 SIST EN 12868:2017

Justification of an N-nitrosamine sp
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