Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
11.1 General
11.2 Resterilization
11.3 Base dimensions
11.4 Effects on diagnostic techniques
11.5 Filling materials
11.6 Information on expected lifetime
11.7 Information for the patient
11.8 Labels
11.9 Information for the user
11.10 Marking on implants
11.11 Manufacturer's device card
Annex A (normative) - Test for surface characteristics
Annex B (normative) - Tests for shell integrity
Annex C (normative) - Test method for valve competence and
injection site competence
Annex D (normative) - Test for silicone gel cohesion (silicone
filling materials only)
Annex E (normative) - Mechanical tests on a mammary
implant in its implantable state
Annex F (normative) - Information for the patient
Annex G (normative) - Information for the user
Annex H (informative) - Silicone release assessment from
mammary implants by an in vitro method
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography