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SN 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

01-09-2021

Published date

12-01-2013

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

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).

DevelopmentNote
1998 Edition Re-issued in September 2009 & incorporates AMD 1 2009. (11/2009)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded
SupersededBy

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