I.S. EN 12006-3:1999
Superseded
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES
Hardcopy , PDF
English
01-01-1999
02-23-2011
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Superseded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 |
| DIN EN 12006-3:1999-01 | Identical |
| DIN EN 12006-3:2009-08 | Identical |
| BS EN 12006-3 : 1999 | Identical |
| UNE-EN 12006-3:1999 | Identical |
| EN 12006-3:1998+A1:2009 | Identical |
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