BS EN ISO 25539-2:2020 Cardiovascular Implants - Endovascular Devices: Vascular Stents

Discover the comprehensive standard that is pivotal for the development, testing, and implementation of vascular stents in the field of cardiovascular implants. The BS EN ISO 25539-2:2020 is an essential document for professionals involved in the design, manufacturing, and quality assurance of endovascular devices.

Overview

This standard, released on October 6, 2020, provides detailed guidelines and specifications for vascular stents, which are critical components in the treatment of cardiovascular diseases. With a total of 126 pages, this document is a comprehensive resource that covers all aspects of vascular stent technology.

Key Features

• Standard Number: BS EN ISO 25539-2:2020
• ISBN: 978 0 539 02797 6
• Status: Standard

Why This Standard is Important

Vascular stents are crucial in the management of cardiovascular conditions, providing support to blood vessels and ensuring proper blood flow. The BS EN ISO 25539-2:2020 standard ensures that these devices meet the highest quality and safety standards, which is vital for patient safety and the effectiveness of medical treatments.

Comprehensive Guidelines

The standard offers a detailed framework for the design and testing of vascular stents, ensuring that they are safe, reliable, and effective. It includes specifications for materials, design, performance, and testing methods, providing a thorough understanding of the requirements for these critical medical devices.

Global Relevance

As an internationally recognized standard, BS EN ISO 25539-2:2020 is relevant to manufacturers and healthcare providers worldwide. It aligns with global best practices, facilitating international trade and ensuring that products meet the expectations of healthcare systems across different countries.

Who Should Use This Standard?

This standard is indispensable for:

• Medical device manufacturers involved in the production of vascular stents.
• Quality assurance professionals ensuring compliance with international standards.
• Regulatory bodies overseeing the approval and monitoring of cardiovascular implants.
• Healthcare providers and clinicians who utilize these devices in patient care.

Benefits of Compliance

Adhering to the BS EN ISO 25539-2:2020 standard offers numerous benefits, including:

• Enhanced Safety: Ensures that vascular stents are safe for patient use, reducing the risk of complications.
• Improved Quality: Promotes high-quality manufacturing processes, leading to reliable and effective medical devices.
• Regulatory Approval: Facilitates the approval process by meeting international regulatory requirements.
• Market Access: Opens up opportunities in global markets by aligning with international standards.

Conclusion

The BS EN ISO 25539-2:2020 standard is a vital resource for anyone involved in the cardiovascular implant industry. By providing a comprehensive set of guidelines and specifications, it ensures that vascular stents are designed and manufactured to the highest standards, ultimately improving patient outcomes and advancing the field of cardiovascular medicine.

Invest in this standard to ensure your products meet the rigorous demands of the healthcare industry and contribute to the advancement of medical technology.

BS EN ISO 25539-2:2020

This standard BS EN ISO 25539-2:2020 Cardiovascular implants. Endovascular devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

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.

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.

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 devices.

Although coated stents and coated stent systems are within the scope of this document, this document is not comprehensive with respect to coatings.

This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.