EN 14299 : 2004

Superseded

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

Available format(s):

Superseded date: 01-09-2008

Language(s):

Published date: 12-01-2013

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

Describes specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery.

General Product Information - (Show below) - (Hide below)

Committee	TC 285
Development Note	Supersedes PREN 14299 (10/2005)
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 25539-1:2017

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	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

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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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