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DIN EN ISO 14607:2009-08

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Hardcopy , PDF

Superseded date

07-29-2020

Language(s)

English

Published date

01-01-2009

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Beabsichtigte Funktion
5 Konstruktionsmerkmale
6 Werkstoffe
7 Konstruktionbewertung
   7.1 Allgemeines
   7.2 Vorklinische Bewertung
   7.3 Klinische Bewertung
   7.4 Produktbeobachtung nach Markteinführung
8 Herstellung
9 Sterilisation
10 Verpackung
11 Bereitstellung von Informationen durch den Hersteller
   11.1 Allgemeines
   11.2 Resterilisation
   11.3 Basismasse
   11.4 Einflüsse auf Diagnoseverfahren
   11.5 Füllmaterialien
   11.6 Angaben über die zu erwartende Lebensdauer
   11.7 Informationen für den Patiententen
   11.8 Etiketten
   11.9 Informationen für den Anwender
   11.10 Kennzeichnung auf Implantaten
   11.11 Produktkarte des Herstellers
Anhang A (normativ) Prüfung auf Oberflächenmerkmale
Anhang B (normativ) Prüfungen auf Zuverlässigkeit
                       der Hülleneigenschaften
Anhang C (normativ) Prüfverfahren für die Zuverlässigkeit
                       des Ventils und der Injektionsstelle
Anhang D (normativ) Prüfung auf Kohäsion des Silikongels
                       (nur für Silikon-Füllmaterialien)
Anhang E (normativ) Mechanische Prüfungen eines
                       Mammaimplantats im implantierbaren
                       Zustand
Anhang F (normativ) Informationen für den Patienten
Anhang G (normativ) Informationen für den Anwender
Anhang H (informativ) Beurteilung der Silikonfreisetzung
                       aus Mammaimplantaten durch ein
                       In-vitro-Vefahren
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen
          dieser Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG

Describes particular requirements for mammary implants for clinical practice.

DevelopmentNote
Supersedes DIN EN 12180. (05/2007) DRAFT 2017 issued in May 2017. (05/2017)
DocumentType
Standard
Pages
37
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
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
DIN EN ISO 14155-1:2009-11 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
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
DIN EN ISO 14155-2:2009-11 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

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