PREN 14299 : DRAFT 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
01-05-2004
12-01-2013
Foreword
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) Table A.1 - 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
Details specific requirements for arterial stents and their deployment intended to correct or compensate a defect of an artery.
| Committee |
TC 285
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 01/564791 DC : DRAFT NOV 2001 | Identical |
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