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BS EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices. Requirements and tests >
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BS EN ISO 7439:2015 Copper-bearing contraceptive intrauterine devices. Requirements and tests, 2015
- Foreword
- Endorsement notice
- 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 [Go to Page]
