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BS EN 71-12:2016:2017 Edition

BS EN 71-12:2016:2017 Edition

$167.15

Safety of toys – N-Nitrosamines and N-nitrosatable substances

Published By Publication Date Number of Pages
BSI 2017 36
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This European Standard specifies the requirements and test methods for N-nitrosamines and N-nitrosatable substances for:

  • toys and parts of toys made from elastomers and intended for use by children under 36 months;

  • toys and parts of toys made from elastomers and intended to be placed in the mouth;

  • finger paints for children under 36 months.

EXAMPLE

Examples of toys made from elastomers are balloons and teethers.

NOTE

With regard to elastomers, up to now N-nitrosamines and N-nitrosatable substances have mainly been detected in vulcanized materials.

PDF Catalog

PDF Pages PDF Title
6 European foreword
8 1 Scope
2 Normative references
3 Terms and definitions
9 4 Requirements
4.1 Requirements for finger paints
Table 1 ā€” List of N-nitrosamines in finger paints
4.2 Requirements for elastomers
Table 2 ā€” Limit values for elastomers
10 Table 3 ā€” List of N-nitrosamines in elastomers
5 Principle
6 Reagents and apparatus
6.1 Reagents
11 6.2 Standards
12 6.3 Apparatus
13 7 Sample preparation
7.1 General
7.2 Finger paints
7.2.1 N-nitrosamines
14 7.2.2 N-nitrosatable substances
7.3 Elastomers
7.3.1 Sample preparation for balloons
7.3.2 Sample preparation for other toys or parts of toys than balloons
15 7.3.3 Nitrosation
7.3.4 Preparation of solution for determination of N-nitrosamines by HPLC-MS/MS
8 Methods of analysis
8.1 General
16 8.2 HPLC chromatographic conditions
Table 4 ā€” Gradient for HPLC conditions
8.3 MS/MS conditions
17 Table 5 ā€” Suitable MRM-transitions for MS/MS conditions
8.4 Confirmation of detected N-nitrosamines
Table 6 ā€” Maximum permitted tolerances for relative ion intensities
18 9 Calculation of results for N-nitrosamines and N-nitrosatable substances
9.1 Finger paint
9.1.1 General
9.1.2 N-nitrosamines
19 9.1.3 N-nitrosatable substances
9.2 Elastomers
9.2.1 General
20 9.2.2 N-nitrosamines
9.2.3 N-nitrosatable substances
21 10 Method performance
10.1 Finger paints
10.1.1 Repeatability, reproducibility and measurement uncertainty
Table 7 ā€” Results from round robin test on a finger paint containing NDELA
10.1.2 Limits of detection (LOD) and quantification (LOQ)
10.2 Elastomers
10.2.1 Repeatability, reproducibility and measurement uncertainty
22 Table 8 ā€” Results from round robin test on N-nitrosamines and N-nitrosatable substances in elastomers
10.2.2 Limits of detection and quantification
23 11 Test report
24 Annex A (informative) Background and rationale for this European Standard
A.1 Definition of elastomer
A.2 Requirements for finger paints (see 4.1)
25 A.3 Requirements for elastomers (see 4.2)
26 A.4 Avoidance N-nitrosamines in finger paints
A.5 Explanation for decision to do static migration for elastomers and for the specified migration times
27 A.6 Reference to other standards and relevant deviations
A.7 Conditions for nitrosation
28 A.8 NDELA in balloons
A.9 Selection of N-nitrosamines specified in this standard
Figure A.1 ā€” Total ion chromatogram of the 13 given N-nitrosamines of Table 3 using the masses given in Table 5 and using the conditions given in 6.3.8 (column: Nucleodur C18 Sphinx) and 8.2 and 8.3. Elution order (minute/substance(s)): 1.37/NDELA, d8…
29 Annex B (informative) Significant technical changes between this European Standard and the previous version
31 Annex C (informative) Aā€“deviations
32 Annex ZA (informative) Relationship between this European Standard and the essential requirements of EU Directive 2009/48/EC aimed to be covered
Table ZA.1 ā€” Correspondence between this European Standard and Directive 2009/48/EC
33 Bibliography

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BS EN 71-12:2016
$167.15