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SN EN 12006-3 : 1999 + 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: ENDOVASCULAR DEVICES

Superseded date

07-01-2011

Published date

01-12-2013

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 C (informative) Clauses of this European
        Standard addressing essential requirements
        or other provisions of EU Directives

Details particular requirements for endovascular devices. With reference 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. Vascular occluders are not in this standard.

DevelopmentNote
1999 Edition Re-issued in September 2009 & incorporates AMD 1 2009. (11/2009)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded
SupersededBy

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

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