BS EN ISO 7439:2015 – TC:2020 Edition
$134.27
Tracked Changes. Copper-bearing contraceptive intrauterine devices. Requirements and tests
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 44 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 26 | Foreword Endorsement notice |
| 29 | Foreword |
| 30 | Introduction |
| 31 | 1 Scope 2 Normative references 3 Terms and definitions |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 7.6 Pre-clinical evaluation 7.7 Clinical evaluation |
| 37 | 8 Manufacturing and inspection 9 Sterilization 10 Packaging |
| 38 | 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 |
| 39 | 11.5 Information intended for the woman |
| 41 | Bibliography |
