BS ISO 18241:2016+A1:2019 - Cardiovascular Implants and Extracorporeal Systems

Cardiopulmonary Bypass Systems: Venous Bubble Traps

The BS ISO 18241:2016+A1:2019 standard is an essential document for professionals in the field of cardiovascular implants and extracorporeal systems. This comprehensive standard provides detailed guidelines and specifications for cardiopulmonary bypass systems, with a specific focus on venous bubble traps. Released on December 31, 2019, this standard is a critical resource for ensuring the safety and efficacy of these medical devices.

Standard Number: BS ISO 18241:2016+A1:2019
Pages: 28
ISBN: 978 0 580 51827 0
Status: Standard

Overview

Cardiopulmonary bypass systems are vital components in cardiac surgery, providing life-sustaining support during procedures that require the heart to be stopped. One of the critical elements of these systems is the venous bubble trap, which plays a crucial role in preventing air embolisms by capturing and removing air bubbles from the venous blood before it is returned to the patient's circulation.

The BS ISO 18241:2016+A1:2019 standard outlines the design, performance, and safety requirements for venous bubble traps used in cardiopulmonary bypass systems. By adhering to these guidelines, manufacturers can ensure that their products meet the highest standards of quality and safety, ultimately protecting patients and improving surgical outcomes.

Key Features

• Comprehensive Guidelines: The standard provides detailed instructions on the design and testing of venous bubble traps, ensuring that they effectively capture and remove air bubbles from the blood.
• Safety and Performance: By following the specifications outlined in this standard, manufacturers can ensure that their venous bubble traps meet rigorous safety and performance criteria, reducing the risk of complications during surgery.
• International Recognition: As an ISO standard, BS ISO 18241:2016+A1:2019 is recognized globally, making it an essential reference for manufacturers and healthcare providers around the world.

Benefits

Implementing the guidelines set forth in the BS ISO 18241:2016+A1:2019 standard offers numerous benefits for both manufacturers and healthcare providers. By ensuring that venous bubble traps meet the highest standards of quality and safety, this standard helps to:

• Enhance Patient Safety: By effectively removing air bubbles from the blood, venous bubble traps reduce the risk of air embolisms, a potentially life-threatening complication during cardiac surgery.
• Improve Surgical Outcomes: High-quality venous bubble traps contribute to smoother surgical procedures and better patient outcomes, reducing the likelihood of complications and improving recovery times.
• Facilitate Regulatory Compliance: Adhering to this internationally recognized standard helps manufacturers meet regulatory requirements, streamlining the approval process for their products.

Who Should Use This Standard?

The BS ISO 18241:2016+A1:2019 standard is an invaluable resource for a wide range of professionals involved in the design, manufacture, and use of cardiopulmonary bypass systems. This includes:

• Medical Device Manufacturers: Companies that produce venous bubble traps and other components of cardiopulmonary bypass systems can use this standard to ensure their products meet the highest quality and safety standards.
• Healthcare Providers: Hospitals and surgical centers can reference this standard to evaluate the quality and safety of the venous bubble traps they use, ensuring the best possible care for their patients.
• Regulatory Bodies: Organizations responsible for approving and monitoring medical devices can use this standard as a benchmark for evaluating the safety and efficacy of venous bubble traps.

Conclusion

The BS ISO 18241:2016+A1:2019 standard is a vital tool for ensuring the safety and effectiveness of venous bubble traps used in cardiopulmonary bypass systems. By providing comprehensive guidelines and specifications, this standard helps manufacturers produce high-quality products that enhance patient safety and improve surgical outcomes. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is an essential resource for ensuring the highest standards of quality and safety in cardiovascular implants and extracorporeal systems.

BS ISO 18241:2016+A1:2019

This standard BS ISO 18241:2016+A1:2019 Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.