ISO 7439:2011
Copper-bearing contraceptive intrauterine devices — Requirements and tests
ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.)
It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.
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Scope
Normative references
Terms and definitions
Intended performance
General
Clinical performance
Design attributes
General
Shape
Dimensions
IUD
Copper components
Thread
Insertion instrument
Tensile force
Stability
Shelf-life stability
In situ stability
Visco-elastic property
In situ detection
Materials
Design evaluation
General
Determination of dimensions
Determination of tensile force
Principle
Apparatus
Procedure
Test report
Test of visco-elastic property (memory test)
Principle
Procedure
Test report
Determination of barium sulphate content and identification
Ash content test
Identity test
Pre-clinical evaluation
Clinical evaluation
Manufacturing and inspection
Sterilization
Packaging
Information to be supplied by the manufacturer
General
Labelling of the primary container
Labelling of the secondary container
Instructions for use
Information intended for the woman
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Scope
Normative references
Terms and definitions
Intended performance
General
Clinical performance
Design attributes
General
Shape
Dimensions
IUD
Copper components
Thread
Insertion instrument
Tensile force
Stability
Shelf-life stability
In situ stability
Visco-elastic property
In situ detection
Materials
Design evaluation
General
Determination of dimensions
Determination of tensile force
Principle
Apparatus
Procedure
Test report
Test of visco-elastic property (memory test)
Principle
Procedure
Test report
Determination of barium sulphate content and identification
Ash content test
Identity test
Pre-clinical evaluation
Clinical evaluation
Manufacturing and inspection
Sterilization
Packaging
Information to be supplied by the manufacturer
General
Labelling of the primary container
Labelling of the secondary container
Instructions for use
Information intended for the woman