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EN 14299 : 2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
Superseded date

09-01-2008

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

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Superseded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

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