BS EN ISO 14607:2018
$198.66
Non-active surgical implants. Mammary implants. Particular requirements
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 56 |
This document specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword |
| 6 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 11 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 17 | 4 Intended performance 5 Design attributes 6 Materials 6.1 General |
| 18 | 6.2 Cytotoxicity 6.3 Residual low molecular weight oligomers 6.4 Trace elements 6.5 Physico-mechanical properties and characterization 6.6 Documentation of materials |
| 19 | 7 Design evaluation 7.1 General 7.2 Pre-clinical evaluation 7.2.1 General 7.2.2 Mechanical tests |
| 20 | 7.2.3 Physical evaluation |
| 21 | 7.2.4 Chemical evaluation 7.2.5 Biological evaluation 7.3 Clinical evaluation 7.4 Post-market surveillance 8 Manufacturing 9 Sterilization 10 Packaging |
| 22 | 11 Information supplied by the manufacturer 11.1 General 11.2 Product labelling 11.3 Information for the user 11.3.1 General 11.3.2 Resterilization 11.3.3 Effects on diagnostic techniques 11.4 Marking on implants 11.5 Filling materials 11.6 Information on expected lifetime |
| 23 | 11.7 Information for the patient 11.7.1 General 11.7.2 Patient record label 11.7.3 Patient card |
| 24 | Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels |
| 28 | Annex B (normative) Tests for shell integrity |
| 31 | Annex C (normative) Mechanical tests on a mammary implant in its implantable state |
| 37 | Annex D (normative) Test method for valve competence and injection site competence |
| 39 | Annex E (normative) Test for silicone gel cohesion (silicone filling materials only) |
| 41 | Annex F (normative) Test for silicone gel penetration (silicone filling materials only) |
| 46 | Annex G (informative) Assessment of silicone diffusion from mammary implants using an in vitro method |
| 50 | Annex H (informative) Test for surface characteristics |
| 53 | Annex I (normative) Information for the user |
| 54 | Annex J (normative) Information for the patient |
| 55 | Bibliography |
