NS EN 12180 : 1ED 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS
01-06-2007
12-01-2013
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
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