STN EN ISO 25539-2
| Name: | STN EN ISO 25539-2 |
| Validity: | Valid |
| Number of pages: | 128 |
| Language: |
EN
|
| Paper: | 35,00€ |
| Electronic version |
a) Only read (without ability to print and copy)
31,50€ b) Without ability to print, with ability to copy (printscreen) 35,00€ c) With ability to print and copy (printscreen) 45,50€ |
| Slovak title | Srdcovo-cievne implantáty. Vnútrocievne pomôcky. Časť 2: Cievne stenty (ISO 25539-2: 2020) |
| English title | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020) |
| Release Date: | 01. 03. 2021 |
| Date of withdrawal: | |
| ICS: | 11.040.40 |
| Sorting character/National clasification code | 85 2925 |
| Level of incorporation: | idt EN ISO 25539-2:2020, idt ISO 25539-2:2020 |
| Official Journal | 02/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 25539-2:2013-05 (85 2925) |
| Note in Official Journal: | |
| Subject of the standard: | 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. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary. |
| Preview: | Náhľad normy (PDF) |