EN 12006-3:1998+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
01-02-2011
06-05-2009
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Superseded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 |
Standards | Relationship |
UNI EN 12006-3 : 2009 | Identical |
UNE-EN 12006-3:1999 | Identical |
DIN EN 12006-3:2009-08 | Identical |
NBN EN 12006-3 : 1999 + A1 2009 | Identical |
NS EN 12006-3 : 1998 + A1 2009 | Identical |
NF EN 12006-3 : 1999 + A1 2009 | Identical |
NEN EN 12006-3 : 1998 + A1 2009 | Identical |
I.S. EN 12006-3:1999 | Identical |
SN EN 12006-3 : 1999 + A1 2009 | Identical |
PN EN 12006-3 : 2002 + A1 2009 | Identical |
BS EN 12006-3 : 1999 | Identical |
DIN EN 12006-3:1999-01 | Identical |
UNE-EN 12006-3:1999+A1:2009 | Identical |
BS EN 12006-3:1998+A1:2009 | Identical |
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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