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I.S. EN 12006-3:1999

Superseded

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NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

02-23-2011

Language(s)

English

Published date

01-01-1999

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 supplies by the manufacturer
Annex A (informative) Bibliography
Annex B (informative) Animal studies with stents
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC

Defines particular requirements for endovascular devices With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

DevelopmentNote	1999 Edition Re-issued in July 2009 & incorporates AMD 1 2009. (07/2009)
DocumentType	Standard
Pages	16
PublisherName	National Standards Authority of Ireland
Status	Superseded

Standards	Relationship
UNE-EN 12006-3:1999	Identical
DIN EN 12006-3:1999-01	Identical
DIN EN 12006-3:2009-08	Identical
UNI EN 12006-3 : 2009	Identical
BS EN 12006-3 : 1999	Identical
EN 12006-3:1998+A1:2009	Identical