UNI EN 12180 : 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS
03-05-2007
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
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.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 12180 : 2000 | Identical |
| UNE-EN 12180:2000 | Identical |
| DIN EN 12180:2000-04 | Identical |
| I.S. EN 12180:2000 | Identical |
| BS EN 12180:2000 | Identical |
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