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EN 12868:2017

Current

Current

The latest, up-to-date edition.

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

Published date

01-11-2017

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Reagents
6 Apparatus
7 Standard Solutions of N-nitrosamines
8 Procedure
9 Calculation of results
10 Confirmation of N-nitrosamines
11 Analytical tolerances
12 Compliance
13 Test report
Annex A (informative) - Rationales
Annex B (informative) - Suitable gas chromatographic method
Annex C (normative) - Example of results calculation and test
        report
Annex D (informative) - Alternative Methods
Annex E (informative) - Justification of an N-nitrosamine specific
        adjustment for NDiNA
Annex F (informative) - Summary of the 2015 validation trial
Bibliography

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

DevelopmentNote
Supersedes PREN 12868. (01/2017)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

I.S. EN 14350-2:2004 CHILD USE AND CARE ARTICLES - DRINKING EQUIPMENT - PART 2: CHEMICAL REQUIREMENTS AND TESTS
PD CEN/TR 13387:2004 Child use and care articles. Safety guidelines
DIN ISO 29941 E : 2014 CONDOMS - DETERMINATION OF NITROSAMINES MIGRATING FROM NATURAL RUBBER LATEX CONDOMS (ISO 29941:2010)
I.S. EN 71-12:2016 SAFETY OF TOYS - PART 12: N-NITROSAMINES AND N-NITROSATABLE SUBSTANCES
BS EN 71-12:2016 Safety of toys N-Nitrosamines and N-nitrosatable substances
EN 1400:2013+A1:2014 Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
CEN/TR 13387-2:2015 Child use and care articles - General safety guidelines - Part 2: Chemical hazards
UNI CEN ISO/TR 16178 : 2014 FOOTWEAR - CRITICAL SUBSTANCES POTENTIALLY PRESENT IN FOOTWEAR AND FOOTWEAR COMPONENTS
12/30254126 DC : 0 BS EN 14602 - FOOTWEAR - TEST METHOD FOR THE ASSESSMENT OF ECOLOGICAL CRITERIA
PD CEN/TR 13387-2:2015 Child use and care articles. General safety guidelines Chemical hazards
DIN EN 14350-2:2004-11 CHILD USE AND CARE ARTICLES - DRINKING EQUIPMENT - PART 2: CHEMICAL REQUIREMENTS AND TESTS
DIN EN 1400-3:2002-12 CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - PART 3: CHEMICAL REQUIREMENTS AND TESTS
I.S. EN 14602:2012 FOOTWEAR - TEST METHODS FOR THE ASSESSMENT OF ECOLOGICAL CRITERIA
12/30258105 DC : 0 BS EN 71-12 - SAFETY OF TOYS - PART 12: N-NITROSAMINES AND N-NITROSATABLE SUBSTANCES
15/30315952 DC : 0 BS EN 71-12 - SAFETY OF TOYS - PART 12: N-NITROSAMINES AND N-NITROSATABLE SUBSTANCES
PD CEN ISO/TR 16178:2012 Footwear. Critical substances potentially present in footwear and footwear components
S.R. CEN ISO/TR 16178:2012 FOOTWEAR - CRITICAL SUBSTANCES POTENTIALLY PRESENT IN FOOTWEAR AND FOOTWEAR COMPONENTS (ISO/TR 16178:2012)
S.R. CEN/TR 13387-2:2015 CHILD USE AND CARE ARTICLES - GENERAL SAFETY GUIDELINES - PART 2: CHEMICAL HAZARDS
I.S. CEN TR 13387:2004 CHILD USE AND CARE ARTICLES - SAFETY GUIDELINES
DIN EN 14602:2012-10 Footwear - Test methods for the assessment of ecological criteria
EN 14602:2012 Footwear - Test methods for the assessment of ecological criteria
UNI EN 14602 : 2012 FOOTWEAR - TEST METHODS FOR THE ASSESSMENT OF ECOLOGICAL CRITERIA
PREN 14602 : DRAFT 2012 FOOTWEAR - TEST METHOD FOR THE ASSESSMENT OF ECOLOGICAL CRITERIA
BS ISO 29941:2010 Condoms. Determination of nitrosamines migrating from natural rubber latex condoms
UNE-EN 71-12:2017 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances
I.S. EN 1400:2013 CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - SAFETY REQUIREMENTS AND TEST METHODS
11/30246867 DC : 0 BS EN 1400 - CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - SAFETY REQUIREMENTS AND TEST METHODS
02/700015 DC : DRAFT JAN 2002 BS EN 14350-2 - CHILD CARE ARTICLES - DRINKING EQUIPMENT - CHEMICAL REQUIREMENTS AND TEST METHODS
DIN EN 1400:2014-07 CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - SAFETY REQUIREMENTS AND TEST METHODS
DIN EN 14602 E : 2012 FOOTWEAR - TEST METHODS FOR THE ASSESSMENT OF ECOLOGICAL CRITERIA
CEN ISO/TR 16178:2012 FOOTWEAR - CRITICAL SUBSTANCES POTENTIALLY PRESENT IN FOOTWEAR AND FOOTWEAR COMPONENTS (ISO/TR 16178:2012)
BS EN 1400-3:2002 Child use and care articles. Soothers for babies and young children Chemical requirements and tests
BS EN 14602:2012 Footwear. Test methods for the assessment of ecological criteria
BS EN 14350-2:2004 Child use and care articles. Drinking equipment Chemical requirements and test methods
ISO/TR 16178:2012 Footwear Critical substances potentially present in footwear and footwear components
UNE-EN 14602:2012 Footwear - Test methods for the assessment of ecological criteria
EN 1400-3 : 2002 CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - PART 3: CHEMICAL REQUIREMENTS AND TESTS
EN 71-12:2016 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances
EN 14350-2 : 2004 CHILD USE AND CARE ARTICLES - DRINKING EQUIPMENT - PART 2: CHEMICAL REQUIREMENTS AND TESTS
I.S. EN 1400-3:2002 CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - PART 3: CHEMICAL REQUIREMENTS AND TESTS
DIN ISO 29941:2014-12 Condoms - Determination of nitrosamines migrating from natural rubber latex condoms (ISO 29941:2010)
BS EN 1400 : 2013 CHILD USE AND CARE ARTICLES - SOOTHERS FOR BABIES AND YOUNG CHILDREN - SAFETY REQUIREMENTS AND TEST METHODS
UNE-EN 1400:2013 Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
ISO 29941:2010 Condoms — Determination of nitrosamines migrating from natural rubber latex condoms
CEN/TR 13387 : 2004 CHILD USE AND CARE ARTICLES - SAFETY GUIDELINES

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
EN 71-12:2016 Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances
ISO/TR 22971:2005 Accuracy (trueness and precision) of measurement methods and results Practical guidance for the use of ISO 5725-2:1994 in designing, implementing and statistically analysing interlaboratory repeatability and reproducibility results
TRGS 552 : 2007
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)

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