NS EN 12006-2 : 1998 + A1 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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS

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Superseded date: 01-06-2017

Language(s):

Published date: 12-01-2013

Publisher: Norwegian Standards (Norges Standardiseringsforbund)

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Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 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) Classification of prostheses
Annex B (normative) Bibliography
Annex C (informative) Reference table EN 12006-2 and
ISO/DIS 7198
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
EU Directives

Abstract - (Show below) - (Hide below)

Covers specified requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, reconstruct, bypass or form shunts between segments of the cardio-vascular system in humans. Does not apply to prostheses derived from host tissue (autografts).

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Development Note	1998 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (08/2009)
Document Type	Standard
ISBN
Pages
Published
Publisher	Norwegian Standards (Norges Standardiseringsforbund)
Status	Superseded

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
UNI EN 12006-2 : 2009	Identical
EN 12006-2:1998+A1:2009	Identical
I.S. EN 12006-2:1998	Identical
DIN EN 12006-2:2009-08	Identical
BS EN 12006-2 : 1998	Identical
SN EN 12006-2 : 1998 + A1 2009	Identical

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