{"id":341151,"date":"2024-10-19T23:54:57","date_gmt":"2024-10-19T23:54:57","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-128682017\/"},"modified":"2024-10-25T23:06:09","modified_gmt":"2024-10-25T23:06:09","slug":"bs-en-128682017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-128682017\/","title":{"rendered":"BS EN 12868:2017"},"content":{"rendered":"

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<\/span> <\/span>.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Principle
5 Reagents <\/td>\n<\/tr>\n
11<\/td>\n6 Apparatus <\/td>\n<\/tr>\n
13<\/td>\n7 Standard Solutions of N-nitrosamines
7.1 General
7.2 N-nitrosamines identified in teats <\/td>\n<\/tr>\n
14<\/td>\n7.3 Calibration solutions (for detector response)
7.4 N-nitrosamine used as internal standard
8 Procedure
8.1 General <\/td>\n<\/tr>\n
15<\/td>\n8.2 Sample Preparation <\/td>\n<\/tr>\n
16<\/td>\n8.3 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 <\/td>\n<\/tr>\n
17<\/td>\n8.3.3 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 <\/td>\n<\/tr>\n
18<\/td>\n8.6 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 <\/td>\n<\/tr>\n
19<\/td>\n8.7.1.2 Example
8.7.2 In Extract B
8.8 Blank Test
8.9 Analysis
8.9.1 Calibration function <\/td>\n<\/tr>\n
20<\/td>\n8.9.2 Determination of sample concentration
9 Calculation of results
9.1 General <\/td>\n<\/tr>\n
21<\/td>\n9.2 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 <\/td>\n<\/tr>\n
22<\/td>\n9.3 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 <\/td>\n<\/tr>\n
23<\/td>\n11 Analytical tolerances
11.1 General
11.2 Analytical tolerances (see Annex\u00a0F)
12 Compliance
13 Test report <\/td>\n<\/tr>\n
25<\/td>\nAnnex\u00a0A (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) <\/td>\n<\/tr>\n
26<\/td>\nA.5 Separate migrations (see 8.3.2 and 8.3.3)
A.6 Duplicate tests (see 8.1)
A.7 TEA and alternative detectors <\/td>\n<\/tr>\n
27<\/td>\nA.8 Deviations (see 9.2, 9.3 and 11)
A.9 Main differences between this standard and EN\u00a07112 [3] <\/td>\n<\/tr>\n
28<\/td>\nAnnex\u00a0B (informative)Suitable gas chromatographic method <\/td>\n<\/tr>\n
30<\/td>\nAnnex\u00a0C (normative)Example of results calculation and test report
C.1 General
C.2 Example for variability testing and means calculation for analytical results <\/td>\n<\/tr>\n
32<\/td>\nC.3 Results calculation and results table for test report <\/td>\n<\/tr>\n
33<\/td>\nC.4 Other Information for test report <\/td>\n<\/tr>\n
34<\/td>\nAnnex\u00a0D (informative)Alternative Methods
D.1 General
D.2 Liquid Chromatography (LC) <\/td>\n<\/tr>\n
35<\/td>\nD.3 MS\/MS conditions <\/td>\n<\/tr>\n
36<\/td>\nD.4 Confirmation and quantification of detected N-nitrosamines <\/td>\n<\/tr>\n
38<\/td>\nAnnex\u00a0E (informative)Justification of an N-nitrosamine specific adjustment for NDiNA <\/td>\n<\/tr>\n
40<\/td>\nAnnex\u00a0F (informative)Summary of the 2015 validation trial
F.1 Outline
F.2 Initial statistical analysis \u2013 N-nitrosatable substances <\/td>\n<\/tr>\n
41<\/td>\nF.3 Reproducibility Limit for N-nitrosatable substances <\/td>\n<\/tr>\n
42<\/td>\nF.4 Consideration of the NDiNA Reproducibility limit
F.5 Initial statistical analysis \u2013 N-nitrosamines <\/td>\n<\/tr>\n
43<\/td>\nF.6 Variability between Determinations <\/td>\n<\/tr>\n
44<\/td>\nF.7 Summary of Conclusions and implications for EN\u00a012868 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Child use and care articles. Method for determining the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2017<\/td>\n48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":341159,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-341151","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/341151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/341159"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=341151"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=341151"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=341151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}