UNI 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
24-10-2018
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
11.1 General
11.2 Resterilization
11.3 Base dimensions
11.4 Effects on diagnostic techniques
11.5 Filling materials
11.6 Information on expected lifetime
11.7 Information for the patient
11.8 Labels
11.9 Information for the user
11.10 Marking on implants
11.11 Manufacturer's device card
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
Describes particular requirements for mammary implants for clinical practice.
| DevelopmentNote |
Supersedes UNI EN 12180. (05/2007) Bilingual (Italian + English) version issued in OCTOBER 2011. (03/2012)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14607:2007 | 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 |
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