UNI EN 12006-3 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 3: ENDOVASCULAR DEVICES
14-04-2011
01-01-2009
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 supplied 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
Describes particular requirements for endovascular devices.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN 12006-3:1999 | 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 |
| NFS 91 141 : 1997 | BIODEGRADABILITY OF DENTAL METAL ALLOYS - STANDARDIZATION OF ELECTROCHEMICAL TESTS |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
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