EN ISO 25539-2:2009/AC:2011
(Corrigendum)Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 2 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 2. del: Žilne opornice (stent) (ISO 25539-2:2008)
Ta del ISO 25539 določa zahteve za žilne opornice (stent), zasnovane na sodobnem medicinskem znanju. Z upoštevanjem varnosti podaja zahteve za predvideno delovanje, lastnosti modela, materiale, ovrednotenje zasnove, izdelavo, sterilizacijo, pakiranje in informacije, ki jih priskrbi proizvajalec. Upoštevati se mora kot dodatek ISO 14630, ki določa splošne zahteve za delovanje neaktivnih kirurških implantatov.
General Information
- Status
- Withdrawn
- Publication Date
- 15-Feb-2011
- Withdrawal Date
- 30-Nov-2012
- Technical Committee
- CEN/TC 285 - Non-active surgical implants
- Drafting Committee
- CEN/TC 285/WG 3 - Cardiac and vascular implants
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 01-Dec-2012
- Completion Date
- 01-Dec-2012
Relations
- Effective Date
- 26-Dec-2012
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 25539-2:2009/AC:2011 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)". This standard covers: 2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 2 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).
2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 2 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).
EN ISO 25539-2:2009/AC:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 25539-2:2009/AC:2011 has the following relationships with other standards: It is inter standard links to EN ISO 25539-2:2012, EN 4302:2008, EN 4109:2006, EN 4110:2006, EN 4108:2006, EN ISO 25539-2:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 25539-2:2009/AC:2011 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 25539-2:2009/AC:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008)Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 25539-2:2009/AC:2011SIST EN ISO 25539-2:2009/AC:2011en,fr,de01-julij-2011SIST EN ISO 25539-2:2009/AC:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 25539-2:2009/AC
February 2011
Février 2011
Februar 2011 ICS 11.040.40 English version Version Française Deutsche Fassung
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008) This c
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