CEN/TC 285/WG 3 - Cardiac and vascular implants

This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
NOTE 1  Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices.
NOTE 2  Vascular device-drug combination products are within the scope of ISO 12417-1.
Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these d

2011-12-06 EMA: Draft for // vote received in ISO/CS (see notification of 2011-12-02 in dataservice).
MINOR REVISION      MINOR REVISION       MINOR REVISION       MINOR REVISION      MINOR REVISION

2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 1 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).

ISO 25539-1:2003 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
ISO 25539-1:2003 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.
ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.

This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.
This European Standard is not applicable to prostheses derived from host tissue (autografts).
NOTE   A valve conduit is regarded as a composite prosthesis and falls within the scope of this standard.
With regard to safety it gives in addition to EN ISO 14630:1997, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
This European Standard specifies the designation of materials of the manufacturer and the construction of the device, and the designation of sizes and dimensions of vascular prostheses. It specifies biological requirements for the materials of construction and for the finished product by references to appropriate International and European Standards.
In addition this European Standard specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties stated by the manufacturer, including durability testing.
This standard also gives requirements for packaging and labelling. It provides definitions of the terms in common use.
This European Standard does not specify all possible performance or dimensional characteristics. In such cases, the European Standard does however include methods to verify the nominal values stated by the manufacturer.

2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 2 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).

ISO 25539-2:2008 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The scope of ISO 25539-2:2008 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1:2003. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1:2003 and ISO 25539-2:2008.
Delivery systems are included in ISO 25539-2:2008 if they comprise an integral component of the deployment of the vascular stent.
Some pharmacological aspects of drug eluting stents are addressed in ISO 25539-2:2008, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.
With the exception of sterilization, ISO 25539-2:2008 does not address requirements for the evaluation of animal tissue products.

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 1   Vascular 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 2   Due 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.

2005-12-01  60.60 de-synchornized, ISO/CS failed to notify of publication date.
2000-07-10  This WI should be processed in // VA/ISO lead with the revision of ISO 5840.
2000-04-20  Pending because the WI not yet created at ISO (NT).

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 1: Vascular 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 2: Due 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.

This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.  This European Standard is not applicable to prostheses derived from host tissue (autografts).  NOTE: A valve conduit is regarded as a composite prosthesis and falls within the scope of this standard.  With regard to safety it gives in addition to EN ISO 14630:1997, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.  This European Standard specifies the designation of materials of the manufacturer and the construction of the device, and the designation of sizes and dimensions of vascular prostheses. It specifies biological requirements for the materials of construction and for the finished product by references to appropriate international and European Standards.  In addition this European Standard specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties stated by the manufacturer, including durability testing.  This standard gives also requirements for packaging and labelling. It provides definitions of the terms in common use.  This European Standard does not specify all possible performance or dimensional characteristics. In such cases, the European Standard does however include methods to verify the nominal values stated by the manufacturer.

This European Standard specifies specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery.
With regard to safety, this standard gives in addition to EN ISO 14630:1997 and
EN 12006-3:1998 specific requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
This European Standard applies to arterial stents and endovascular prostheses used in the aorta, cervical segments of cerebral arteries, coronary arteries, intra-cerebral arteries, peripheral arteries, pulmonary arteries, supra-aortic arteries and visceral arteries. It also includes endovascular prostheses used to treat aneurysms, arterial stenoses, or other vascular abnormalities.
NOTE 1   Delivery systems are included in this standard if they comprise an integral component of the deployment of the implant.
NOTE 2   Covered stents used as occluders are included in this standard.

This standard specifies particular requirements for heart valve substitutes.           This European Standard is not applicable to heart valve substitutes composed in whole, or in part, of human tissue.           With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.           This European Standard specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes and of the materials and components of which they are made.           Recommendations are also made for in vivo testing and clinical evaluation, and for the reporting of results of all types of testing and evaluation covered in this European Standard. These recommendations do not purport to comprise a complete test programme (see annex F for rationale).