BS EN ISO 80369-7:2021: Small-bore Connectors for Liquids and Gases in Healthcare Applications

In the ever-evolving world of healthcare, ensuring the safety and reliability of medical devices is paramount. The BS EN ISO 80369-7:2021 standard is a crucial document that addresses the design and performance of small-bore connectors used in intravascular or hypodermic applications. Released on May 24, 2021, this standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies who are committed to maintaining the highest standards of patient safety and care.

Overview of the Standard

The BS EN ISO 80369-7:2021 standard provides comprehensive guidelines for the design and testing of small-bore connectors that are used in healthcare settings for the delivery of liquids and gases. These connectors are critical components in medical devices, ensuring that fluids and gases are safely and effectively administered to patients. The standard is part of a series of standards that aim to reduce the risk of misconnections between different medical devices, which can lead to serious patient harm.

Key Features

• Standard Number: BS EN ISO 80369-7:2021
• Pages: 56
• Released: 2021-05-24
• ISBN: 978 0 539 06119 2
• Status: Standard

Importance of Small-bore Connectors

Small-bore connectors are integral to the safe and effective delivery of medical treatments. They are used in a variety of applications, including intravenous therapy, blood transfusions, and the administration of medications. The design of these connectors must prevent accidental disconnections and misconnections, which can have severe consequences for patient health.

The BS EN ISO 80369-7:2021 standard sets out the requirements for the dimensions, performance, and testing of these connectors, ensuring that they are compatible with other medical devices and that they function reliably under various conditions. By adhering to this standard, manufacturers can produce connectors that meet the highest safety and quality standards, thereby enhancing patient safety and improving clinical outcomes.

Who Should Use This Standard?

This standard is an invaluable resource for a wide range of stakeholders in the healthcare industry, including:

• Medical Device Manufacturers: To ensure that their products meet international safety and performance standards.
• Healthcare Providers: To understand the specifications and requirements of the connectors they use in patient care.
• Regulatory Bodies: To assess compliance with safety standards and to guide policy development.
• Quality Assurance Professionals: To implement rigorous testing and quality control processes.

Benefits of Compliance

Compliance with the BS EN ISO 80369-7:2021 standard offers numerous benefits, including:

• Enhanced Patient Safety: By reducing the risk of misconnections and ensuring reliable performance.
• Regulatory Compliance: Meeting international standards facilitates market access and regulatory approval.
• Improved Product Quality: Adhering to stringent design and testing requirements ensures high-quality products.
• Increased Trust: Demonstrating a commitment to safety and quality builds trust with healthcare providers and patients.

Conclusion

The BS EN ISO 80369-7:2021 standard is a vital tool for ensuring the safety and effectiveness of small-bore connectors used in healthcare applications. By providing clear guidelines for design, performance, and testing, this standard helps to prevent misconnections and enhance patient safety. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is an essential resource for maintaining the highest standards of care and safety in the medical field.

Invest in the BS EN ISO 80369-7:2021 standard today to ensure that your products and practices meet the rigorous demands of modern healthcare, and contribute to a safer, more reliable healthcare environment for all.

BS EN ISO 80369-7:2021

This standard BS EN ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.

This document does not specify requirements for the following small-bore connectors, which are specified in other documents:

1. haemodialyser, haemodiafilter and haemofilter blood compartment ports ( ISO 8637 ^{[ 5 ]} and applicable portion of ISO 8638 ^{[ 6 ]} referencing blood compartment ports);

2. haemodialysis, haemodiafiltration and haemofiltration equipment connectors ( ISO 8637 ^{[ 5 ]});

3. infusion system closure piercing connectors ( ISO 8536-4 ^{[ 4 ]}).