ISO 7439:2023
Copper-bearing contraceptive intrauterine devices — Requirements and tests
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
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
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
5.2.9 Labelling
6 Design attributes
6.1 General
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
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
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
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
9 Manufacturing and inspection
10 Sterilization
11 Packaging
12 Information to be supplied by the manufacturer
12.1 General
12.2 Labelling of the primary container
12.3 Labelling of the secondary container
12.4 Instructions for the health care providers
12.5 Information intended for the client after insertion of the IUD
12.6 Written information intended for the client
Annex A (normative) Sampling requirements for testing copper bearing IUDs
Bibliography
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BS EN ISO 7439:2023
Copper-bearing contraceptive intrauterine devices. Requirements and tests
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BS ISO 11249:2018
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality verification
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
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
5.2.9 Labelling
6 Design attributes
6.1 General
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
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
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
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
9 Manufacturing and inspection
10 Sterilization
11 Packaging
12 Information to be supplied by the manufacturer
12.1 General
12.2 Labelling of the primary container
12.3 Labelling of the secondary container
12.4 Instructions for the health care providers
12.5 Information intended for the client after insertion of the IUD
12.6 Written information intended for the client
Annex A (normative) Sampling requirements for testing copper bearing IUDs
Bibliography