UNE-EN 12006-3:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: ENDOVASCULAR DEVICES.
Hardcopy , PDF
19-04-2011
UNE-EN 12006-3:1999+A1:2009
UNE-EN ISO 25539-1:2009
UNE-EN ISO 25539-2:2013
UNE-EN ISO 25539-3:2012
Spanish, Castilian
16-02-1999
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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.
| Committee |
CTN 91
|
| DevelopmentNote |
1999 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNI EN 12006-3 : 2009 | Identical |
| DIN EN 12006-3:2009-08 | Identical |
| NBN EN 12006-3 : 1999 + A1 2009 | Identical |
| NS EN 12006-3 : 1998 + A1 2009 | Identical |
| EN 12006-3:1998+A1:2009 | Identical |
| NF EN 12006-3 : 1999 + A1 2009 | Identical |
| NEN EN 12006-3 : 1998 + A1 2009 | Identical |
| I.S. EN 12006-3:1999 | Identical |
| SN EN 12006-3 : 1999 + A1 2009 | Identical |
| BS EN 12006-3 : 1999 | Identical |
| DIN EN 12006-3:1999-01 | Identical |
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