I.S. EN ISO 14607:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018)
Hardcopy , PDF
English
01-01-2009
04-02-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
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
Defines particular requirements for mammary implants.
| DevelopmentNote |
Supersedes I.S. EN 12180. (04/2007)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14607:2007 | Identical |
| EN ISO 14607:2009 | Equivalent |
| 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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