EN 12180 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
01-02-2007
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.
| Committee |
TC 285
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 12180 : 2000 | Identical |
| NS EN 12180 : 1ED 2000 | Identical |
| SN EN 12180 : 2000 | Identical |
| BS EN 12180:2000 | Identical |
| UNE-EN 12180:2000 | Identical |
| UNI EN 12180 : 2001 | Identical |
| I.S. EN 12180:2000 | Identical |
| NF EN 12180 : 2000 | Identical |
| DIN EN 12180:2000-04 | Identical |
| NBN EN 12180 : 2000 | Identical |
| MEDDEV 2.5-7 : REV 1 : 1998 | GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES |
| NFT 46 007 : 1978 | VULCANIZED RUBBERS - DETERMINATION OF THE TEAR STRENGTH (ANGLE TESTPIECES, WITH OR WITHOUT NICK AND CRESCENT TESTPIECES) |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| NFT 46 002 : 1988 | VULCANIZED OR THERMOPLASTIC RUBBER - TENSILE TEST |
| ASTM D 3389 : 2016 : REDLINE | Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| NFS 99 401 : 1994 | MEDICAL DEVICES - SILICONE ELASTOMETER OF MEDICAL GRADE |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.