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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 43<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 4 Requirements 4.1 Requirements for finger paints Table 1 \u2014 List of N-nitrosamines in finger paints 4.2 Requirements for elastomers Table 2 \u2014 Limit values for elastomers <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Table 3 \u2014 List of N-nitrosamines in elastomers 5 Principle 6 Reagents and apparatus 6.1 Reagents <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 6.2 Standards <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | 6.3 Apparatus <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 7 Sample preparation 7.1 General 7.2 Finger paints 7.2.1 N-nitrosamines <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 8.2 HPLC chromatographic conditions Table 4 \u2014 Gradient for HPLC conditions 8.3 MS\/MS conditions <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Table 5 \u2014 Suitable MRM-transitions for MS\/MS conditions 8.4 Confirmation of detected N-nitrosamines Table 6 \u2014 Maximum permitted tolerances for relative ion intensities <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 9 Calculation of results for N-nitrosamines and N-nitrosatable substances 9.1 Finger paint 9.1.1 General 9.1.2 N-nitrosamines <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | 9.1.3 N-nitrosatable substances 9.2 Elastomers 9.2.1 General <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 9.2.2 N-nitrosamines 9.2.3 N-nitrosatable substances <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | 10 Method performance 10.1 Finger paints 10.1.1 Repeatability, reproducibility and measurement uncertainty Table 7 \u2014 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 <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | Table 8 \u2014 Results from round robin test on N-nitrosamines and N-nitrosatable substances in elastomers 10.2.2 Limits of detection and quantification <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | 11 Test report <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Annex A (informative) Background and rationale for this European Standard A.1 Definition of elastomer A.2 Requirements for finger paints (see 4.1) <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | A.3 Requirements for elastomers (see 4.2) <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | A.6 Reference to other standards and relevant deviations A.7 Conditions for nitrosation <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | A.8 NDELA in balloons A.9 Selection of N-nitrosamines specified in this standard Figure A.1 \u2014 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… <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | Annex B (informative) Significant technical changes between this European Standard and the previous version <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | Annex C (informative) A\u2013deviations <\/td>\n<\/tr>\n | ||||||
| 69<\/td>\n | 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 \u2014 Correspondence between this European Standard and Directive 2009\/48\/EC <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Safety of toys – N-Nitrosamines and N-nitrosatable substances<\/b><\/p>\n |