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  • EN 12868:2017

    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

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    Published date:  11-01-2017

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes PREN 12868. (01/2017)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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