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UNI EN ISO 14607 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
Superseded date

10-24-2018

Published date

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Superseded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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