BS EN ISO 14607:2009
Withdrawn
View Superseded by
Non-active surgical implants. Mammary implants. Particular requirements
Hardcopy , PDF
English
11-30-2009
09-28-2018
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) - Test for surface characteristics
Annex B (normative) - Tests for shell integrity
Annex C (normative) - Test method for valve competence and
injection site competence
Annex D (normative) - Test for silicone gel cohesion
(silicone filling materials only)
Annex E (normative) - Mechanical tests on a mammary implant
in its implantable state
Annex F (normative) - Information for the patient
Annex G (normative) - Information for the user
Annex H (informative) - Silicone release assessment from
mammary implants by an in vitro
method
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive 93/42/EEC
Describes particular requirements for mammary implants for clinical practice.
| Committee |
CH/150
|
| DevelopmentNote |
Supersedes BS EN 12180. (12/2008)
|
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14607:2007 | Identical |
| DIN EN ISO 14607:2009-08 | Equivalent |
| I.S. EN ISO 14607:2009 | Equivalent |
| EN ISO 14607:2009 | Identical |
| EN ISO 14607:2018 | Identical |
| UNE-EN ISO 14607:2009 | Equivalent |
| EN ISO 14607:2009 | Equivalent |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| ISO 16054:2000 | Implants for surgery — Minimum data sets for surgical implants |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans |
| CR 14060:2000 | Medical device traceability |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects — Part 1: General requirements |
| 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 |
| 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 |
| 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 |
| NFS 99 401 : 1994 | MEDICAL DEVICES - SILICONE ELASTOMETER OF MEDICAL GRADE |
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