EN 14299 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
09-01-2008
01-12-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) Cross reference of specific aims
Annex B (informative) Definitions of reportable clinical
events
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or
other provisions of EU Directives
Bibliography
Describes specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery.
Committee |
TC 285
|
DevelopmentNote |
Supersedes PREN 14299 (10/2005)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
NBN EN 14299 : 2004 | Identical |
NEN EN 14299 : 2004 | Identical |
NS EN 14299 : 1ED 2004 | Identical |
I.S. EN 14299:2004 | Identical |
PN EN 14299 : 2005 | Identical |
SN EN 14299 : 2004 | Identical |
UNI EN 14299 : 2004 | Identical |
UNE-EN 14299:2004 | Identical |
BS EN 14299:2004 | Identical |
NF EN 14299 : 2004 | Identical |
DIN EN 14299 E : 2004 | Identical |
DIN EN 14299:2004-08 | Identical |
UNE-EN ISO 25539-2:2013 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
ANSI/AAMI/ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
ASTM F 2394 : 2007 : R2013 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
EN ISO 25539-2:2012 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
ASTM F 2394 : 2007 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
BS EN ISO 25539-2:2012 | Cardiovascular implants. Endovascular devices Vascular stents |
I.S. EN ISO 25539-2:2012 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
UNI EN ISO 25539-2 : 2013 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
ASTM F 2394 : 2007 : R2017 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
ISO 25539-2:2012 | Cardiovascular implants Endovascular devices Part 2: Vascular stents |
ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
EN 12006-2:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
ISO 14630:2012 | Non-active surgical implants — General requirements |
EN ISO 10555-4:2013 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013) |
EN 12006-3:1998+A1:2009 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
EN ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.