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
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 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
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