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I.S. 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 14607:2018)
Available format(s)

Hardcopy , PDF

Superseded date

04-02-2019

Language(s)

English

Published date

01-01-2009

Preview

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Superseded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 14607:2018 Identical

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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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