Cardiovascular implants. Endovascular devices - Vascular stents

BS EN ISO 25539-2:2009 Cardiovascular implants. Endovascular devices. Vascular stents

BS EN ISO 25539-2 has been prepared in order to provide minimum requirements for endovascular devices and the methods of test that will enable their evaluation.

It is the second part of a proposed three-part standard. BS EN SO 25539-1 addresses endovascular prostheses and ISO 25539-3 will address vena cava filters.

Those using the arterial stent standard EN 14299:2004 should be aware that it will no longer give presumption of conformity to the Medical Devices Directive as of 21 March 2010.

It has been superseded by the recently published EN ISO 25539-1:2009 Cardiovascular implants. Endovascular devices. Endovascular prostheses and EN ISO 25539-2:2009 Cardiovascular implants. Endovascular devices. Vascular stents.

The date of withdrawal coincides with the enforcement date of the amended MDD and will impact any medical devices manufacturers that CE mark their products.

ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for the requirements of this document. The Technical Specification ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the potential device and clinical failure modes. Tests were then identified to address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment.

This part of ISO 25539 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.

BS EN ISO 25539 consists of the following parts, under the general title Cardiovascular implants. Endovascular devices:

• Part 1: Endovascular prostheses
• Part 2: Vascular stents

Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. bioabsorbable stents, polymeric stents), 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.

The scope of this part of ISO 25539 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. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539.

Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the deployment of the vascular stent.

Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this part of ISO 25539.

Some pharmacological aspects of drug eluting stents are addressed in this part of ISO 25539, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.

Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO 25539.

With the exception of sterilization, BS EN ISO 25539-2:2009 does not address requirements for the evaluation of animal tissue products.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. An informative annex has been added to cover the relationship with the EU Directive.

Contents of BS EN ISO 25539-2 include:

• Scope
• Normative references
• Terms and definitions
• General requirements
• Classification
• Size
• Intended clinical use designation
• Intended performance
• Design attributes
• Delivery system and stent system
• Implant
• Materials
• Design evaluation
• Sampling
• Conditioning of test samples
• Reporting
• Delivery system and stent system
• Stent
• Preclinical in vivo evaluation
• Clinical evaluation
• Post market surveillance
• Manufacturing
• Sterilization
• Products supplied sterile
• Products supplied non-sterile
• Sterilization residuals
• Packaging
• Protection from damage in storage and transport
• Marking
• Information supplied by the manufacturer
• Attributes of endovascular devices — Vascular stents — Technical and clinical considerations
• Bench and analytical tests
• Definitions of reportable clinical events
• Test methods
• Supplement to fatigue durability test analytical approach
• Bibliography

BS EN ISO 25539-2:2009 replaces BS EN ISO 25539-2:2008 Cardiovascular implants. Endovascular devices. Vascular stents which has been withdrawn.

Also available for cardiovascular implants