BS EN ISO 14607:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Non-active surgical implants. Mammary implants. Particular requirements
Hardcopy , PDF
09-28-2018
English
11-30-2009
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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Withdrawn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 |
| EN ISO 14607:2009 | Identical |
| EN ISO 14607:2018 | Identical |
| 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 |
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.