I.S. EN ISO 25539-2:2020
Current
The latest, up-to-date edition.
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
Hardcopy , PDF
English
19-10-2020
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for stent systems
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) Relationship between testing requirements, device attributes, and potential failure modes and guidance for the creation of a device evaluation strategy
Annex B (informative) Description of clinical effects of failure
Annex C (informative) Description of device effects of failure
Annex D (informative) Test methods
Bibliography
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge
| Committee |
TC 150
|
| DocumentType |
Standard
|
| Pages |
134
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERES TO : AAMI TIR 42,ASME V&V40,
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 25539-2:2020 | Identical |
| ISO 25539-2:2020 | Identical |
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