DIN EN 12180:2000-04

Foreword
Introduction
1 Scope
2 Normative references
3 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) Surface characteristics
Annex B (normative) Tests for shell integrity
Annex C (normative) Test requirements for valve competence
                    and injection site competence
Annex D (normative) Tests for silicone gel cohesion
Annex E (normative) Mechanical tests on mammary implant
                    in its implantable state
Annex ZA (informative) Clauses of this European Standard
                       addressing essential requirements or
                       other provisions of EU Directives
Bibliography

Defines specific criteria for mammary implants for clinical practice. Gives the requirements for intended performance, design attributes and evaluation, materials, manufacturing, sterilization, information and packaging supplied by the manufacturer.