BS EN ISO 80369-20:2024 - Small-bore Connectors for Liquids and Gases in Healthcare Applications: Common Test Methods

Introducing the BS EN ISO 80369-20:2024, a pivotal standard that sets the benchmark for small-bore connectors used in healthcare applications. This comprehensive document is essential for professionals in the medical and healthcare industries, providing a detailed framework for the common test methods applicable to small-bore connectors for liquids and gases. Released on November 28, 2024, this standard is the latest in ensuring safety, reliability, and efficiency in medical device connectivity.

Key Features of BS EN ISO 80369-20:2024

• Standard Number: BS EN ISO 80369-20:2024
• Pages: 42
• ISBN: 978 0 539 17360 4
• Status: Standard

This standard is meticulously crafted to address the critical need for standardized testing methods for small-bore connectors, which are integral to the safe and effective delivery of liquids and gases in healthcare settings. With 42 pages of in-depth guidelines, it provides a robust framework for manufacturers, healthcare providers, and regulatory bodies to ensure that these connectors meet the highest standards of safety and performance.

Why BS EN ISO 80369-20:2024 is Essential

In the complex world of healthcare, the precision and reliability of medical devices are paramount. Small-bore connectors are used extensively in various medical applications, from intravenous therapy to respiratory care. The BS EN ISO 80369-20:2024 standard is designed to mitigate the risks associated with misconnections and ensure that these connectors function correctly under all conditions.

By adhering to the guidelines set forth in this standard, manufacturers can ensure that their products are not only compliant with international safety regulations but also optimized for performance. This is crucial in maintaining the trust of healthcare professionals and patients alike, as well as in reducing the incidence of adverse events related to connector failures.

Comprehensive Testing Methods

The BS EN ISO 80369-20:2024 standard outlines a series of rigorous test methods that are essential for evaluating the performance of small-bore connectors. These tests are designed to assess various aspects of connector functionality, including:

• Leakage Prevention: Ensuring that connectors do not allow the unintended escape of liquids or gases, which could compromise patient safety.
• Mechanical Strength: Evaluating the durability of connectors under various stress conditions to prevent breakage or disconnection during use.
• Compatibility: Testing the connectors' ability to function seamlessly with other medical devices and systems, reducing the risk of misconnections.
• Environmental Resistance: Assessing the connectors' performance in different environmental conditions, such as temperature and humidity variations.

These comprehensive testing methods ensure that every aspect of connector performance is scrutinized, providing peace of mind to healthcare providers and patients alike.

Global Relevance and Compliance

The BS EN ISO 80369-20:2024 standard is recognized globally, making it a critical component for manufacturers aiming to enter international markets. Compliance with this standard not only demonstrates a commitment to quality and safety but also facilitates smoother regulatory approvals across different regions.

For healthcare institutions, adopting products that meet the BS EN ISO 80369-20:2024 standard is a testament to their dedication to patient safety and care excellence. It ensures that the equipment used within their facilities adheres to the highest international standards, thereby enhancing their reputation and trustworthiness.

Conclusion

The BS EN ISO 80369-20:2024 standard is an indispensable resource for anyone involved in the design, manufacture, or use of small-bore connectors in healthcare applications. Its comprehensive guidelines and rigorous testing methods provide a solid foundation for ensuring the safety, reliability, and effectiveness of these critical components.

By integrating the principles of this standard into their operations, manufacturers can enhance their product offerings, healthcare providers can improve patient outcomes, and regulatory bodies can uphold the highest standards of medical device safety. Embrace the future of healthcare connectivity with the BS EN ISO 80369-20:2024 standard.

BS EN ISO 80369-20:2024

• 11.040.25 Syringes, needles and catheters
• 11.040.20 Transfusion, infusion and injection equipment
• 11.040.10 Anaesthetic, respiratory and reanimation equipment