BS ISO 25539-4:2021 Cardiovascular Implants - Endovascular Devices

Standard Number: BS ISO 25539-4:2021

Pages: 20

Released: 2021-11-15

ISBN: 978 0 539 05879 6

Name: Cardiovascular implants. Endovascular devices Application of ISO 17327-1 for coated endovascular devices

Status: Standard

Overview

The BS ISO 25539-4:2021 standard is a crucial document for professionals in the field of cardiovascular implants and endovascular devices. This standard provides comprehensive guidelines and specifications for the application of ISO 17327-1, specifically tailored for coated endovascular devices. Released on November 15, 2021, this 20-page document is an essential resource for ensuring the highest quality and safety standards in the development and implementation of these medical devices.

Key Features

• Comprehensive Guidelines: The standard offers detailed instructions and criteria for the application of ISO 17327-1, ensuring that coated endovascular devices meet the highest quality and safety standards.
• Up-to-Date Information: Released in 2021, this standard reflects the latest advancements and best practices in the field of cardiovascular implants and endovascular devices.
• International Recognition: As an ISO standard, BS ISO 25539-4:2021 is recognized and respected globally, making it a valuable resource for professionals and organizations worldwide.
• Focused Content: With 20 pages of targeted information, this standard provides a concise yet thorough overview of the necessary requirements and guidelines for coated endovascular devices.

Benefits

Adhering to the BS ISO 25539-4:2021 standard offers numerous benefits for manufacturers, healthcare providers, and patients alike:

• Enhanced Safety: By following the guidelines outlined in this standard, manufacturers can ensure that their coated endovascular devices are safe for use, reducing the risk of complications and adverse events.
• Improved Quality: The standard's comprehensive criteria help manufacturers produce high-quality devices that meet stringent international standards, leading to better patient outcomes.
• Regulatory Compliance: Compliance with this ISO standard can facilitate regulatory approval processes, making it easier for manufacturers to bring their products to market.
• Global Acceptance: As an internationally recognized standard, BS ISO 25539-4:2021 can help manufacturers gain acceptance and trust in global markets, expanding their reach and potential customer base.

Target Audience

This standard is designed for a wide range of professionals and organizations involved in the development, manufacturing, and implementation of cardiovascular implants and endovascular devices, including:

• Medical device manufacturers
• Regulatory bodies
• Healthcare providers
• Research and development teams
• Quality assurance professionals

Why Choose BS ISO 25539-4:2021?

Choosing the BS ISO 25539-4:2021 standard ensures that you are adhering to the most current and comprehensive guidelines for coated endovascular devices. This standard not only helps you meet regulatory requirements but also enhances the safety and quality of your products, ultimately leading to better patient outcomes and increased trust in your brand.

Conclusion

The BS ISO 25539-4:2021 standard is an indispensable resource for anyone involved in the field of cardiovascular implants and endovascular devices. With its detailed guidelines, up-to-date information, and international recognition, this standard provides the foundation for producing high-quality, safe, and effective coated endovascular devices. By adhering to this standard, you can ensure regulatory compliance, improve patient outcomes, and gain a competitive edge in the global market.

BS ISO 25539-4:2021

This standard BS ISO 25539-4:2021 Cardiovascular implants. Endovascular devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics