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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
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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
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
BS EN 12868:2017
$189.07