NBN EN 12006-3 : 1999 + A1 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-01-2012
12-01-2013
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 August 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| 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Superseded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 |
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