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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
6 European foreword
Endorsement notice
9 Foreword
10 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
12 4 Quality verification
13 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
14 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
15 5.2.9 Labelling
6 Design attributes
6.1 General
16 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
17 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
18 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
19 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
20 9 Manufacturing and inspection
10 Sterilization
11 Packaging
12 Information to be supplied by the manufacturer
12.1 General
21 12.2 Labelling of the primary container
12.3 Labelling of the secondary container
12.4 Instructions for the health care providers
22 12.5 Information intended for the client after insertion of the IUD
23 12.6 Written information intended for the client
24 Annex A (normative) Sampling requirements for testing copper bearing IUDs
26 Bibliography

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BS EN ISO 7439:2023
$142.49