BS EN 14299:2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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. Specific requirements for arterial stents
Hardcopy , PDF
09-30-2009
English
06-08-2004
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and 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) Cross reference of specific aims
Annex B (informative) Definitions of reportable clinical
events
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or
other provisions of EU Directives
Bibliography
Describes specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery.
| Committee |
CH/150/2
|
| DevelopmentNote |
Supersedes 01/564791 DC. (06/2004)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN 14299 : 2004 | Identical |
| UNI EN 14299 : 2004 | Identical |
| NEN EN 14299 : 2004 | Identical |
| UNE-EN 14299:2004 | Identical |
| NF EN 14299 : 2004 | Identical |
| NS EN 14299 : 1ED 2004 | Identical |
| EN 14299:2004 | Identical |
| NBN EN 14299 : 2004 | Identical |
| I.S. EN 14299:2004 | Identical |
| DIN EN 14299:2004-08 | Identical |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| EN 12006-2:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| EN ISO 10555-4:2013 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
| EN 12006-3:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| EN ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| 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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