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BS EN ISO 7439:2015

BS EN ISO 7439:2015

$102.76

Copper-bearing contraceptive intrauterine devices. Requirements and tests

Published By Publication Date Number of Pages
BSI 2015 22
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PDF Catalog

PDF Pages PDF Title
4 Foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Intended performance
4.1 General
4.2 Clinical performance
5 Design attributes
5.1 General
5.2 Shape
5.3 Dimensions
5.3.1 IUD
5.3.2 Copper components
11 5.3.3 Thread
5.3.4 Insertion instrument
5.4 Tensile force
5.5 Stability
5.5.1 Shelf-life stability
5.5.2 In situ stability
5.6 Visco-elastic property
5.7 In situ detection
6 Materials
12 7 Design evaluation
7.1 General
7.2 Determination of dimensions
7.3 Determination of tensile force
7.3.1 Principle
7.3.2 Apparatus
7.3.3 Procedure
7.3.4 Test report
13 7.4 Test of visco-elastic property (memory test)
7.4.1 Principle
7.4.2 Procedure
7.4.3 Test report
7.5 Determination of barium sulfate content and identification of barium and sulfate
7.5.1 Ash content test
7.5.2 Identity test
14 7.6 Pre-clinical evaluation
7.7 Clinical evaluation
15 8 Manufacturing and inspection
9 Sterilization
10 Packaging
16 11 Information to be supplied by the manufacturer
11.1 General
11.2 Labelling of the primary container
11.3 Labelling of the secondary container
11.4 Instructions for use
17 11.5 Information intended for the woman
19 Bibliography

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BS EN ISO 7439:2015
$102.76