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BS EN ISO 14607:2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Non-active surgical implants. Mammary implants. Particular requirements
Available format(s)

Hardcopy , PDF

Withdrawn date

09-28-2018

Language(s)

English

Published date

11-30-2009

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Withdrawn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 14607:2018 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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