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BS EN 14375:2016

BS EN 14375:2016

$102.76

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

Published By Publication Date Number of Pages
BSI 2016 22
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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
4 Contents Page
6 1 Scope
2 Normative references
7 3 Terms and definitions
4 Requirements
4.1 General requirements
4.2 Performance requirements
4.2.1 Child test
8 4.2.2 Adult test
5 Testing
5.1 Principle
5.2 Samples and sample preparation
9 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
10 5.3.3 Adult test
5.3.3.1 Composition of adult test group
5.3.3.2 Test procedure
11 5.4 Evaluation
5.4.1 Child test
5.4.1.1 General
5.4.1.2 Test charts
12 5.4.1.3 Expression of results
5.4.2 Adult test
5.5 Overall test result
6 Test report
6.1 General
13 6.2 Child test
6.3 Adult test
6.4 Additional (optional) information to be recorded
6.5 Overall test result
14 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
15 Annex B (normative)Test charts
18 Annex C (informative)Suitability of the sequential procedures chosen

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BS EN 14375:2016
$102.76