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DIN EN 12006-2:2009-08

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS

Available format(s)

Hardcopy , PDF

Superseded date

01-07-2017

Language(s)

English

Published date

01-01-2009

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Beabsichtigte Funktion
5 Konstruktionsmerkmale
6 Werkstoffe
   6.1 Biologische Verträglichkeit und
       biologische Stabilität
   6.2 Chemische Eigenschaften - Nomenklatur
7 Beurteilung der Konstruktion
   7.1 Funktionsmerkmale
       7.1.1 Verbundprothesen
       7.1.2 Kombinierte Prothesen
       7.1.3 Kombinierte kardiovaskuläre
             Prothesen (Klappen-Konduit)
   7.2 Anforderungen an Prothesen im
       Endzustand
   7.3 Probenahme
   7.4 Prüfverfahren
   7.5 Vorklinische Bewertung in vivo
   7.6 Klinische Bewertung
   7.7 Prüfberichte
8 Herstellung
9 Sterilisation
10 Verpackung
11 Bereitstellung von Informationen durch
   den Hersteller
Anhang A (normativ) Klassifizierung von Prothesen
Anhang B (informativ) Literaturverzeichnis
Anhang C (informativ) Gegenüberstellung von
          EN 12006-2 und ISO/DIS 7198
Anhang ZA (informativ) Zusammenhang zwischen
          dieser Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG

Das Dokument legt besondere Anforderungen für Gefässprothesen und kardiovaskuläre Patches synthetischer oder biologischer Herkunft fest, die im menschlichen Herz-Gefäss-system zum Ersatz, zur Rekonstruktion, zum Bypassaufbau oder zur Shuntbildung zwischen diesen Teilen bestimmt sind.

DevelopmentNote
A transition period, as set out in DIN EN ISO 7198 issue 08-2009, exists until 31-03-2020. (07/2017)
DocumentType
Standard
Pages
15
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
ISO 2960:1974 Textiles — Determination of bursting strength and bursting distension — Diaphragm method
ISO 5084:1996 Textiles Determination of thickness of textiles and textile products
ISO 2076:2013 Textiles Man-made fibres Generic names
ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
EN ISO 10993-7 : 2008 COR 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
ISO 5081:1977 Textiles Woven fabrics Determination of breaking strength and elongation (Strip method)
ISO 14630:2012 Non-active surgical implants — General requirements
ISO 472:2013 Plastics Vocabulary
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)

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