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BS EN 12868:2017 – TC:2020 Edition

BS EN 12868:2017 – TC:2020 Edition

$246.62

Tracked Changes. 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 2020 105
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Tests have shown quite different results for Nitrosatables and that the tests are not reliable. The objective of the work will be to find a better way to determine Nitrosatables

PDF Catalog

PDF Pages PDF Title
1 compares BS EN 12868:2017
2 TRACKED CHANGES
Text example 1 — indicates added text (in green)
66 1 Scope
2 Normative references
3 Terms and definitions
67 4 Principle
5 Reagents
68 6 Apparatus
70 7 Standard Solutions of N-nitrosamines
7.1 General
7.2 N-nitrosamines identified in teats
71 7.3 Calibration solutions (for detector response)
7.4 N-nitrosamine used as internal standard
8 Procedure
8.1 General
72 8.2 Sample Preparation
73 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
74 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
75 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
76 8.7.1.2 Example
8.7.2 In Extract B
8.8 Blank Test
8.9 Analysis
8.9.1 Calibration function
77 8.9.2 Determination of sample concentration
9 Calculation of results
9.1 General
78 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
79 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
80 11 Analytical tolerances
11.1 General
11.2 Analytical tolerances (see Annex F)
12 Compliance
13 Test report
82 Annex 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)
83 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
84 A.8 Deviations (see 9.2, 9.3 and 11)
A.9 Main differences between this standard and EN 7112 [3]
85 Annex B (informative)Suitable gas chromatographic method
87 Annex C (normative)Example of results calculation and test report
C.1 General
C.2 Example for variability testing and means calculation for analytical results
89 C.3 Results calculation and results table for test report
90 C.4 Other Information for test report
91 Annex D (informative)Alternative Methods
D.1 General
D.2 Liquid Chromatography (LC)
92 D.3 MS/MS conditions
93 D.4 Confirmation and quantification of detected N-nitrosamines
95 Annex E (informative)Justification of an N-nitrosamine specific adjustment for NDiNA
97 Annex F (informative)Summary of the 2015 validation trial
F.1 Outline
F.2 Initial statistical analysis – N-nitrosatable substances
98 F.3 Reproducibility Limit for N-nitrosatable substances
99 F.4 Consideration of the NDiNA Reproducibility limit
F.5 Initial statistical analysis – N-nitrosamines
100 F.6 Variability between Determinations
101 F.7 Summary of Conclusions and implications for EN 12868

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BS EN 12868:2017 - TC
$246.62