BS EN ISO 80369-6:2016

Comprehensive Standard for Small-Bore Connectors in Healthcare

BS EN ISO 80369-6:2016 is the essential standard for small-bore connectors used in healthcare applications. This comprehensive specification ensures the safety and compatibility of these critical components, protecting patients and healthcare professionals alike.

Ensuring Patient Safety and Compatibility

Small-bore connectors are ubiquitous in modern healthcare, used to link a wide range of medical devices and deliver vital fluids and gases. BS EN ISO 80369-6:2016 establishes strict design and performance requirements for these connectors, including:

• Dimensional specifications to ensure proper fit and function
• Mechanical strength and durability to withstand the demands of clinical use
• Compatibility with common medical gases and liquids, including oxygen, air, and various pharmaceuticals
• Tamper-evident features to prevent accidental disconnection or misuse

By standardizing these critical design elements, BS EN ISO 80369-6:2016 helps to eliminate the risk of patient harm due to connector incompatibility or failure.

Compliance with the Latest Regulations

This British Standard is fully aligned with the latest healthcare regulations and directives, including:

• Medical Device Regulation (MDR) 2017/745 for the European Union
• FDA regulations for the United States market
• ISO 80369 series of standards for small-bore connectors

Conformance with BS EN ISO 80369-6:2016 demonstrates a manufacturer's commitment to patient safety and regulatory compliance, streamlining the path to market for new medical devices and components.

Key Features and Benefits

• Comprehensive design and performance specifications for small-bore connectors used in healthcare applications
• Ensures compatibility and safety across a wide range of medical devices and equipment
• Aligns with the latest international regulations and standards, including MDR 2017/745 and FDA requirements
• Supports the development of innovative medical technologies by providing a clear, standardized framework
• Protects patients and healthcare workers from the risks of connector failure or misuse

Whether you're a medical device manufacturer, healthcare provider, or regulatory body, BS EN ISO 80369-6:2016 is an essential resource for ensuring the safety and compatibility of small-bore connectors in the modern healthcare landscape.