National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (normative) - Determination of octamethylcyclotetrasiloxane
(D4) and decamethylcyclopentasiloxane (D5)
in silicone gels
Annex B (normative) - Tests for shell integrity
Annex C (normative) - Mechanical tests on a mammary
implant in its implantable state
Annex D (normative) - Test method for valve competence
and injection site competence
Annex E (normative) - Test for silicone gel cohesion (silicone
filling materials only)
Annex F (normative) - Test for silicone gel penetration
(silicone filling materials only)
Annex G (informative) - Assessment of silicone diffusion
from mammary implants using an in vitro method
Annex H (informative) - Test for surface characteristics
Annex I (normative) - Information for the user
Annex J (normative) - Information for the patient
Bibliography
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