EN ISO 14607:2018
Current
The latest, up-to-date edition.
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
16-05-2018
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
ISO 14607:2018 specifies particular requirements for mammary implants.With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
| Committee |
CEN/TC 285
|
| DevelopmentNote |
Supersedes EN 12180. (04/2007)
|
| DocumentType |
Standard
|
| ProductNote |
THIS STANDARD ALSO IDENTICAL TO ISO 14607:2018
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 14607:2018&LC:2018 | Identical |
| UNE-EN ISO 14607:2018 | Identical |
| SN EN ISO 14607:2018 | Identical |
| NEN-EN-ISO 14607:2018 | Identical |
| ÖNORM EN ISO 14607:2018 | Identical |
| NBN EN ISO 14607 : 2009 | Identical |
| NS EN ISO 14607 : 2009 | Identical |
| PN-EN ISO 14607:2018-08 | Identical |
| PN EN ISO 14607 : 2009 | Identical |
| BS EN ISO 14607:2009 | Identical |
| ISO 14607:2007 | Identical |
| NF EN ISO 14607:2018 | Identical |
| ISO 14607:2018 | Identical |
| SN EN ISO 14607 : 2009 | Identical |
| DIN EN ISO 14607:2009-08 | Identical |
| I.S. EN ISO 14607:2018 | Identical |
| NEN EN ISO 14607 : 2009 | Identical |
| DIN EN ISO 14607:2018-10 | Identical |
| UNI EN ISO 14607:2018 | Identical |
| I.S. EN ISO 14607:2009 | Identical |
| UNE-EN ISO 14607:2009 | Identical |
| ONORM EN ISO 14607 : 2009 | Identical |
| NF EN ISO 14607 : 2009 | Identical |
| UNI EN ISO 14607 : 2009 | Identical |
| NS EN ISO 14607 : 2018 | Identical |
| BS EN ISO 14607:2018 | Identical |
| SS-EN ISO 14607:2018 | Identical |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 16054:2000 | Implants for surgery Minimum data sets for surgical implants |
| CR 14060:2000 | Medical device traceability |
| ASTM D 792 : 2013 : REDLINE | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 37:2017 | Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 25178-2:2012 | Geometrical product specifications (GPS) Surface texture: Areal Part 2: Terms, definitions and surface texture parameters |
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