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BS EN 71-12:2016 – TC:2020 Edition

BS EN 71-12:2016 – TC:2020 Edition

$217.84

Tracked Changes. Safety of toys – N-Nitrosamines and N-nitrosatable substances

Published By Publication Date Number of Pages
BSI 2020 73
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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. EXAMPLES Examples of toys made from elastomers are balloons and teethers.

PDF Catalog

PDF Pages PDF Title
43 European foreword
45 1 Scope
2 Normative references
3 Terms and definitions
46 4 Requirements
4.1 Requirements for finger paints
Table 1 — List of N-nitrosamines in finger paints
4.2 Requirements for elastomers
Table 2 — Limit values for elastomers
47 Table 3 — List of N-nitrosamines in elastomers
5 Principle
6 Reagents and apparatus
6.1 Reagents
48 6.2 Standards
49 6.3 Apparatus
50 7 Sample preparation
7.1 General
7.2 Finger paints
7.2.1 N-nitrosamines
51 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
52 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
53 8.2 HPLC chromatographic conditions
Table 4 — Gradient for HPLC conditions
8.3 MS/MS conditions
54 Table 5 — Suitable MRM-transitions for MS/MS conditions
8.4 Confirmation of detected N-nitrosamines
Table 6 — Maximum permitted tolerances for relative ion intensities
55 9 Calculation of results for N-nitrosamines and N-nitrosatable substances
9.1 Finger paint
9.1.1 General
9.1.2 N-nitrosamines
56 9.1.3 N-nitrosatable substances
9.2 Elastomers
9.2.1 General
57 9.2.2 N-nitrosamines
9.2.3 N-nitrosatable substances
58 10 Method performance
10.1 Finger paints
10.1.1 Repeatability, reproducibility and measurement uncertainty
Table 7 — 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
59 Table 8 — Results from round robin test on N-nitrosamines and N-nitrosatable substances in elastomers
10.2.2 Limits of detection and quantification
60 11 Test report
61 Annex A (informative) Background and rationale for this European Standard
A.1 Definition of elastomer
A.2 Requirements for finger paints (see 4.1)
62 A.3 Requirements for elastomers (see 4.2)
63 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
64 A.6 Reference to other standards and relevant deviations
A.7 Conditions for nitrosation
65 A.8 NDELA in balloons
A.9 Selection of N-nitrosamines specified in this standard
Figure A.1 — 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…
66 Annex B (informative) Significant technical changes between this European Standard and the previous version
68 Annex C (informative) A–deviations
69 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 — Correspondence between this European Standard and Directive 2009/48/EC
70 Bibliography

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BS EN 71-12:2016 - TC
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