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01/564791 DC : DRAFT NOV 2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

06-08-2004

Published date

11-23-2012

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

BS EN 14299

Committee
CH/23
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN 14299 : DRAFT 2001 Identical

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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