EN ISO 25539-1:2009/AC:2011
(Corrigendum)Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 1 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 1. del: Znotrajžilne proteze (ISO 25539-1:2003, vključno z Amd 1:2005)
1.1 Ta del ISO 25539 določa zahteve za znotrajžilne proteze, 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.
1.2 Ta del ISO 25539 velja za znotrajžilne proteze, uporabljene za zdravljenje arterijskih anevrizem, arterijskih stenoz ali drugih ustreznih žilnih nepravilnostih.
1.3 Ta del ISO 25539 velja za sisteme prenosa, če vsebujejo sestavni del postavitve znotrajžilnih protez.
1.4 Ta del ISO 25539 ne velja za žilne zapore, razen iliakalnih zapor v nasprotni smeri, kadar so uporabljene kot sestavni del aortnega uni-iliakalnega pripomočka. Glej ISO 14360 za izvzete proizvode.
1.5 Ta del ISO 25539 ne velja za postopke in pripomočke, uporabljene pred predstavitvijo znotrajžilnega sistema (določeno v točki 3.6), kot so znotrajžilne naprave z balonom.
General Information
- Status
- Withdrawn
- Publication Date
- 15-Feb-2011
- Withdrawal Date
- 20-Jan-2026
- 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
- 15-Mar-2017
- Completion Date
- 28-Jan-2026
Relations
- Effective Date
- 22-Mar-2017
- Effective Date
- 28-Jan-2026
- 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
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN ISO 25539-1:2009/AC:2011 is a corrigendum published by the European Committee for Standardization (CEN). Its full title is "Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)". This standard covers: 2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 1 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 1 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).
EN ISO 25539-1:2009/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 25539-1:2009/AC:2011 has the following relationships with other standards: It is inter standard links to EN ISO 25539-1:2017, EN ISO 5211:2017, EN 4108:2006, EN 4302:2008, EN 4109:2006, EN 4110:2006, EN ISO 25539-1:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 25539-1:2009/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 25539-1:2009/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 1: Endovaskuläre Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005)Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 25539-1:2009/AC:2011SIST EN ISO 25539-1:2009/AC:2011en,fr,de01-julij-2011SIST EN ISO 25539-1:2009/AC:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 25539-1:2009/AC
February 2011
Février 2011
Februar 2011 ICS 11.040.40 English version Version Française Deutsche Fassung
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)
Kardiovaskuläre Implantate - Endovaskuläre Imp
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...