BS EN 14375:2016 – TC:2020 Edition

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Tracked Changes. Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing

Published By	Publication Date	Number of Pages
BSI	2020	0

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Category: BSI

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This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This European Standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

PDF Catalog

PDF Pages	PDF Title
25	Contents Page
27	1 Scope 2 Normative references
28	3 Terms and definitions 4 Requirements 4.1 General requirements 4.2 Performance requirements 4.2.1 Child test
29	4.2.2 Adult test 5 Testing 5.1 Principle 5.2 Samples and sample preparation
30	5.3 Procedure 5.3.1 General 5.3.2 Child test 5.3.2.1 Composition of child test group 5.3.2.2 Test procedure
31	5.3.3 Adult test 5.3.3.1 Composition of adult test group 5.3.3.2 Test procedure
32	5.4 Evaluation 5.4.1 Child test 5.4.1.1 General 5.4.1.2 Test charts
33	5.4.1.3 Expression of results 5.4.2 Adult test 5.5 Overall test result 6 Test report 6.1 General
34	6.2 Child test 6.3 Adult test 6.4 Additional (optional) information to be recorded 6.5 Overall test result
35	Annex A (informative)Guidance for persons supervising tests with children A.1 Parental/guardian consent A.2 Surroundings and personnel A.3 Social circumstances of the children A.4 History of previous poisoning A.5 Avoidance of distractions A.6 Position of the children A.7 Behaviour of the supervisor during the test
36	Annex B (normative)Test charts
39	Annex C (informative)Suitability of the sequential procedures chosen