ISO 7439:2015
Copper-bearing contraceptive intrauterine devices — Requirements and tests
ISO 7439:2015 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
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
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
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
7.6 Pre-clinical evaluation
7.7 Clinical evaluation
8 Manufacturing and inspection
9 Sterilization
10 Packaging
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
11.5 Information intended for the woman
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
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
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
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
7.6 Pre-clinical evaluation
7.7 Clinical evaluation
8 Manufacturing and inspection
9 Sterilization
10 Packaging
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
11.5 Information intended for the woman
Bibliography