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BS EN ISO 7439:2023

BS EN ISO 7439:2023

$142.49

Copper-bearing contraceptive intrauterine devices. Requirements and tests

Published By Publication Date Number of Pages
BSI 2023 28
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This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. NOTE       Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Quality verification
11 5 Intended clinical performance
5.1 General
5.2 Clinical performance
5.2.1 General
5.2.2 Study duration
5.2.3 Study population
12 5.2.4 Sample size
5.2.5 Contraceptive performance
5.2.6 Expulsion rate
5.2.7 Discontinuation rate
5.2.8 Investigation report
13 5.2.9 Labelling
6 Design attributes
6.1 General
14 6.2 Shape
6.3 Dimensions
6.3.1 IUD
6.3.2 Copper components
6.3.3 Thread
6.3.4 Insertion instrument
6.4 Tensile force
15 6.5 Stability
6.5.1 Shelf-life stability
6.6 Viscoelastic property
6.7 Detection by X-ray
7 Materials
8 Design evaluation
8.1 General
16 8.2 Determination of dimensions
8.3 Determination of tensile force
8.3.1 Principle
8.3.2 Apparatus
8.3.3 Procedure
8.3.4 Test report
17 8.4 Test of elastic recovery (memory test)
8.4.1 Principle
8.4.2 Procedure
8.4.3 Test report
8.5 Determination of barium sulfate content and identification of barium and sulfate
8.5.1 Ash content test
8.5.2 Identity test
8.6 Pre-clinical evaluation
18 9 Manufacturing and inspection
10 Sterilization
11 Packaging
12 Information to be supplied by the manufacturer
12.1 General
19 12.2 Labelling of the primary container
12.3 Labelling of the secondary container
12.4 Instructions for the health care providers
20 12.5 Information intended for the client after insertion of the IUD
21 12.6 Written information intended for the client
22 Annex A (normative) Sampling requirements for testing copper bearing IUDs
24 Bibliography

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BS EN ISO 7439:2023
$142.49