BS EN 12868:2017
$189.07
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 By | Publication Date | Number of Pages |
BSI | 2017 | 48 |
This European Standard specifies the method for determining N-nitrosamines and N-nitrosatable substances released from elastomer or rubber teats in contact with artificial saliva salt solution for testing compliance with Directive 93/11/EEC .
PDF Catalog
PDF Pages | PDF Title |
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9 | 1 Scope 2 Normative references 3 Terms and definitions |
10 | 4 Principle 5 Reagents |
11 | 6 Apparatus |
13 | 7 Standard Solutions of N-nitrosamines 7.1 General 7.2 N-nitrosamines identified in teats |
14 | 7.3 Calibration solutions (for detector response) 7.4 N-nitrosamine used as internal standard 8 Procedure 8.1 General |
15 | 8.2 Sample Preparation |
16 | 8.3 Sample A (for determination of N-nitrosatable substances) 8.3.1 Preparation and pre-boiling 8.3.2 Preparation of Migrate A (for determining N-nitrosatable substances) See A.2 |
17 | 8.3.3 Nitrosation of Migrate A (see A.3) and preparation of Solution A 8.4 Sample B (for determination of N-nitrosamines) 8.4.1 Preparation and pre-boiling 8.4.2 Preparation of Migrate B (for determining N-nitrosamines) 8.4.3 Preparation of Solution B 8.5 Preparation of extraction columns for Solutions A and B |
18 | 8.6 Extraction of N-nitrosamines 8.6.1 From Solution A 8.6.2 From Solution B 8.7 Concentration of N-nitrosamines 8.7.1 In Extract A 8.7.1.1 General Procedure |
19 | 8.7.1.2 Example 8.7.2 In Extract B 8.8 Blank Test 8.9 Analysis 8.9.1 Calibration function |
20 | 8.9.2 Determination of sample concentration 9 Calculation of results 9.1 General |
21 | 9.2 Variability of results and calculation of means 9.2.1 Requirements for variability 9.2.2 Test for variability 9.2.3 Calculation of means |
22 | 9.3 Amount of total N-nitrosatable substances migrating from Sample A, analysed and expressed as N-nitrosamines from Concentrate A 9.4 Amount of total N-nitrosamines migrating from Sample B, analysed and expressed as N-nitrosamines from Concentrate B 10 Confirmation of N-nitrosamines |
23 | 11 Analytical tolerances 11.1 General 11.2 Analytical tolerances (see AnnexĀ F) 12 Compliance 13 Test report |
25 | AnnexĀ A (informative)Rationales A.1 General A.2 Migration Conditions (see 8.3.2) A.3 Nitrosation conditions (see 8.3.3) A.4 Weight of sample used (see 8.3.1) |
26 | A.5 Separate migrations (see 8.3.2 and 8.3.3) A.6 Duplicate tests (see 8.1) A.7 TEA and alternative detectors |
27 | A.8 Deviations (see 9.2, 9.3 and 11) A.9 Main differences between this standard and ENĀ 7112 [3] |
28 | AnnexĀ B (informative)Suitable gas chromatographic method |
30 | AnnexĀ C (normative)Example of results calculation and test report C.1 General C.2 Example for variability testing and means calculation for analytical results |
32 | C.3 Results calculation and results table for test report |
33 | C.4 Other Information for test report |
34 | AnnexĀ D (informative)Alternative Methods D.1 General D.2 Liquid Chromatography (LC) |
35 | D.3 MS/MS conditions |
36 | D.4 Confirmation and quantification of detected N-nitrosamines |
38 | AnnexĀ E (informative)Justification of an N-nitrosamine specific adjustment for NDiNA |
40 | AnnexĀ F (informative)Summary of the 2015 validation trial F.1 Outline F.2 Initial statistical analysis ā N-nitrosatable substances |
41 | F.3 Reproducibility Limit for N-nitrosatable substances |
42 | F.4 Consideration of the NDiNA Reproducibility limit F.5 Initial statistical analysis ā N-nitrosamines |
43 | F.6 Variability between Determinations |
44 | F.7 Summary of Conclusions and implications for ENĀ 12868 |