BS EN ISO 7199:2024 - Cardiovascular Implants and Artificial Organs: Blood-Gas Exchangers (Oxygenators)

Introducing the latest standard in the field of cardiovascular implants and artificial organs, the BS EN ISO 7199:2024. This comprehensive document is an essential resource for professionals involved in the design, manufacturing, and application of blood-gas exchangers, commonly known as oxygenators. Released on September 25, 2024, this standard is a crucial update for ensuring the highest quality and safety in medical devices that play a vital role in life-saving procedures.

Key Features of BS EN ISO 7199:2024

• Standard Number: BS EN ISO 7199:2024
• Pages: 32
• ISBN: 978 0 539 18478 5
• Status: Standard

Why This Standard Matters

The BS EN ISO 7199:2024 standard is pivotal for the medical industry, particularly in the realm of cardiovascular health. Blood-gas exchangers, or oxygenators, are critical components used during cardiac surgeries and other medical procedures that require the temporary replacement of lung function. These devices ensure that blood is oxygenated and carbon dioxide is removed, mimicking the natural process of the lungs.

With the increasing complexity and demand for precision in medical devices, adhering to the latest standards is not just a regulatory requirement but a commitment to patient safety and care. The BS EN ISO 7199:2024 provides detailed guidelines and specifications that manufacturers and healthcare providers must follow to ensure the efficacy and safety of these life-supporting devices.

Comprehensive Coverage

This 32-page document offers a thorough exploration of the requirements for blood-gas exchangers. It covers a wide range of topics, including:

• Design and construction requirements
• Performance criteria
• Testing methods and protocols
• Safety and risk management
• Quality assurance and control measures

Each section is meticulously crafted to provide clear and actionable guidance, ensuring that all aspects of the device's lifecycle are addressed, from initial design to final deployment in clinical settings.

Who Should Use This Standard?

The BS EN ISO 7199:2024 is indispensable for a variety of stakeholders in the medical field, including:

• Medical device manufacturers
• Quality assurance professionals
• Regulatory compliance officers
• Healthcare providers and clinicians
• Research and development teams

By integrating this standard into their operations, these professionals can ensure that their products meet the highest standards of safety and performance, ultimately enhancing patient outcomes and trust in medical technologies.

Stay Ahead with the Latest Standards

In the fast-evolving field of medical technology, staying updated with the latest standards is crucial. The BS EN ISO 7199:2024 not only reflects the current state of technology but also anticipates future advancements, providing a framework that is both robust and adaptable.

Whether you are involved in the development of new medical devices or the implementation of existing technologies, this standard is a valuable tool that will help you navigate the complexities of regulatory compliance and product development.

Conclusion

The BS EN ISO 7199:2024 is more than just a document; it is a commitment to excellence in the field of cardiovascular implants and artificial organs. By adhering to this standard, you are ensuring that your products are not only compliant but also at the forefront of medical innovation.

Equip yourself with the knowledge and guidelines provided in this standard to enhance the safety, reliability, and effectiveness of blood-gas exchangers. Embrace the future of medical technology with confidence and precision.

BS EN ISO 7199:2024

This standard BS EN ISO 7199:2024 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques requiring blood-gas exchange. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. This document does not apply to —     implanted oxygenators, —     liquid oxygenators, —     extracorporeal circuits (blood tubing), —     separate heat exchangers, —     separate ancillary devices, and —     separate arterial line filters.