01/564791 DC : DRAFT NOV 2001

Superseded

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BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS

Available format(s):

Superseded date: 08-06-2004

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

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

Foreword
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) Table A.1 - 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

Abstract - (Show below) - (Hide below)

BS EN 14299

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

Comment Closes On
Committee	CH/23
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN 14299:2004

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
PREN 14299 : DRAFT 2001	Identical

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

ISO 11070:2014	Sterile single-use intravascular introducers, dilators and guidewires
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 5840:2005	Cardiovascular implants Cardiac valve prostheses
ISO 10555-2:1996	Sterile, single-use intravascular catheters Part 2: Angiographic catheters
ISO 7198:2016	Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
EN 540 : 1993	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
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 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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