BS EN ISO 25539-3:2024 Cardiovascular Implants - Endovascular Devices: Vena Cava Filters

Introducing the latest standard in cardiovascular implants, the BS EN ISO 25539-3:2024, which focuses on endovascular devices, specifically vena cava filters. This comprehensive document is an essential resource for professionals in the medical device industry, healthcare providers, and researchers who are involved in the development, implementation, and regulation of cardiovascular implants.

Overview

The BS EN ISO 25539-3:2024 standard provides detailed guidelines and specifications for vena cava filters, which are critical devices used to prevent pulmonary embolism by capturing blood clots that travel from the lower extremities to the lungs. This standard ensures that these devices meet the highest safety and performance criteria, thereby enhancing patient outcomes and advancing medical technology.

Key Features

• Standard Number: BS EN ISO 25539-3:2024
• Pages: 110
• Release Date: October 24, 2024
• ISBN: 978 0 539 17110 5
• Status: Standard

Comprehensive Coverage

This standard spans 110 pages, offering an in-depth exploration of the design, testing, and clinical evaluation of vena cava filters. It provides a framework for manufacturers to ensure that their products are safe, effective, and compliant with international regulations. The document covers various aspects, including:

• Design specifications and material requirements
• Performance testing and validation procedures
• Clinical evaluation and risk assessment
• Labeling and packaging requirements
• Post-market surveillance and reporting

Why This Standard Matters

Vena cava filters play a crucial role in preventing life-threatening conditions such as pulmonary embolism. By adhering to the BS EN ISO 25539-3:2024 standard, manufacturers can ensure that their devices are reliable and effective, thereby safeguarding patient health. This standard not only facilitates regulatory compliance but also fosters innovation by providing a clear set of guidelines for product development.

Who Should Use This Standard?

This standard is indispensable for a wide range of stakeholders, including:

• Medical device manufacturers and designers
• Regulatory bodies and compliance officers
• Healthcare providers and clinical researchers
• Quality assurance and control professionals

Enhancing Patient Safety

Patient safety is at the forefront of the BS EN ISO 25539-3:2024 standard. By establishing rigorous testing and evaluation criteria, this standard helps to minimize risks associated with vena cava filters. It ensures that these devices perform as intended, reducing the likelihood of complications and improving patient outcomes.

Global Relevance

As an internationally recognized standard, the BS EN ISO 25539-3:2024 facilitates global harmonization in the field of cardiovascular implants. It enables manufacturers to access international markets by ensuring that their products meet universally accepted safety and performance benchmarks. This global relevance is crucial for fostering innovation and collaboration across borders.

Conclusion

The BS EN ISO 25539-3:2024 standard is a vital resource for anyone involved in the development and regulation of vena cava filters. Its comprehensive guidelines ensure that these life-saving devices are safe, effective, and compliant with international standards. By adopting this standard, stakeholders can contribute to the advancement of medical technology and the enhancement of patient care worldwide.

BS EN ISO 25539-3:2024

This standard BS EN ISO 25539-3:2024 Cardiovascular implants. Endovascular devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with 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, a revision of this document will be necessary. This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites. This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. This document is not applicable to —           temporary filters (e.g. tethered) that need to be removed after a defined period of time, —           issues associated with viable tissues and non-viable biological materials, and —           procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure. Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices. NOTE 2       Absorbable implants are covered in ISO/TS 17137. Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings. NOTE 3       Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.