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EN 12006-3:1998+A1:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

Superseded date

01-02-2011

Published date

06-05-2009

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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplies by the manufacturer
Annex A (informative) - Bibliography
Annex B (informative) - Animal studies with stents
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

This European Standard specifies particular requirements for endovascular devices.With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.NOTE 1Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products.NOTE 2Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available.Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary.

Committee
CEN/TC 285
DevelopmentNote
1998 Edition Re-Issued in May 2009 & incorporates AMD 1 2009. (06/2009)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

UNE-EN ISO 25539-2:2013 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
UNE-EN ISO 25539-3:2012 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
ANSI/AAMI/ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
ISO 25539-3:2011 Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
DIN EN ISO 25539-3:2012-03 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
BS EN 14299:2004 Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents
EN ISO 25539-2:2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DIN EN 14299:2004-08 NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
I.S. EN 14299:2004 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
10/30196945 DC : 0 BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
01/564791 DC : DRAFT NOV 2001 BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
BS ISO 25539-1 : 2003 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
I.S. EN ISO 25539-2:2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
AAMI ISO 25539-3 : 2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
I.S. EN ISO 25539-3:2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011)
UNI EN ISO 25539-3 : 2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
01/563350 DC : DRAFT AUG 2001 BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
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)
ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
EN 14299:2004 Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents
BS EN ISO 25539-3:2011 Cardiovascular implants. Endovascular devices Vena cava filters
BS EN ISO 25539-2:2012 Cardiovascular implants. Endovascular devices Vascular stents

NFS 91 141 : 1997 BIODEGRADABILITY OF DENTAL METAL ALLOYS - STANDARDIZATION OF ELECTROCHEMICAL TESTS
ISO 14630:2012 Non-active surgical implants — 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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