ISO 18250-6:2019

Overview

ISO 18250-6:2019 is an international standard developed by the International Organization for Standardization (ISO) specifically addressing medical device connectors used in neural reservoir delivery systems. This standard is part six of the ISO 18250 series, which focuses on connectors for reservoir delivery systems across various healthcare applications. The scope of ISO 18250-6:2019 covers the recommended connectors for the outlet ports of neural reservoirs and the inlet ports of neural giving sets, aimed at reducing misconnection risks and enhancing patient safety in neural medical treatments.

By standardizing connectors for neural applications, ISO 18250-6 ensures compatibility and reliable connection between components, preventing misconnections that could lead to serious medical errors. This specification aligns the neural reservoir connectors with ISO 80369-6 connectors for neuraxial applications, promoting uniformity and safety across healthcare devices.

Key Topics

• Connector Designation: Specifies the use of male N2 neuraxial lock connectors for neural reservoir outlet ports and female N2 neuraxial lock connectors for neural giving set inlet ports.
• Compliance with ISO 80369-6: Connectors must comply with ISO 80369-6, which defines small bore connectors for neuraxial applications, ensuring rigorous performance and usability testing.
• Non-User-Detachable Connectors: Recommendations emphasize connectors should not be detachable by users from reservoirs or giving sets to prevent accidental disconnections.
• Misconnection Risk Mitigation: The standard includes comprehensive analyses showing how the neural connectors minimize risks of misconnections with other medical device connectors like IV spikes or respiratory therapy connectors.
• Design Rationale and History: Informative annexes provide background on the rationale for selection and design history of neural reservoir connectors, along with CAD and engineering assessments to verify connector compatibility and safety.
• Related Normative References: ISO 18250-1 (general requirements) and ISO 80369-6 provide mandatory foundational requirements complemented by this standard.

Applications

ISO 18250-6:2019 is essential for manufacturers, healthcare providers, and engineers involved in designing and deploying neural reservoir delivery systems used in healthcare. Typical applications include:

• Implantable Neural Drug Delivery Systems: Ensuring secure connections between reservoirs and delivery tubing in devices that administer drugs or therapies directly to neural tissues.
• Neuraxial Drug Administration: Facilitating safe fluid delivery for anesthesia or pain management involving spinal or epidural routes.
• Medical Device Manufacturing: Guiding medical device manufacturers to standardize connectors for neural reservoirs and giving sets in compliance with international safety and interoperability standards.
• Healthcare Risk Management: Minimizing patient risk by reducing misconnections, which can cause severe injury or treatment failure.
• Device Design Validation: Supporting engineering teams in validating connector designs through 3D CAD modeling and mechanical testing aligned with ISO 18250-1 and ISO 80369-6 requisites.

Related Standards

ISO 18250-6:2019 is part of a comprehensive series of connector standards for reservoir delivery systems in healthcare and is closely linked with the following key standards:

• ISO 18250-1: General requirements and test methods for connectors used in reservoir delivery systems.
• ISO 80369-6: Small bore connectors intended specifically for neuraxial applications, establishing performance and safety criteria.
• ISO 18250-3: Connectors for enteral applications, covering feeding tubes and related systems.
• ISO 18250-7: Connectors for intravascular infusion, addressing vascular access devices.
• ISO 18250-8: Connectors for citrate-based anticoagulant solutions in apheresis.
• ISO 8536-4 and ISO 1135-4: Infusion sets and transfusion equipment standards referenced to prevent misconnection.
• ISO 17256 and ISO/IEC 80601-2-74: Respiratory therapy and humidifying equipment connectors potentially overlapping in healthcare environments.

These interconnected standards ensure broad coverage of reservoir delivery system connectors, facilitating safe and effective fluid delivery for various medical applications, with ISO 18250-6 focusing specifically on neural systems.

Keywords: ISO 18250-6, neural reservoir connectors, medical device connectors, neural delivery systems, neuraxial lock connectors, healthcare standards, medical device safety, ISO 80369-6, misconnections prevention, reservoir delivery system connectors.