BS ISO 18250-6:2019 - Medical Devices: Connectors for Reservoir Delivery Systems in Neural Applications

In the ever-evolving world of healthcare, ensuring the safety and efficiency of medical devices is paramount. The BS ISO 18250-6:2019 standard is a crucial document that addresses the specific requirements for connectors used in reservoir delivery systems, particularly for neural applications. Released on March 19, 2019, this standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and implementation of medical devices.

Key Features of BS ISO 18250-6:2019

• Standard Number: BS ISO 18250-6:2019
• Pages: 14
• Release Date: March 19, 2019
• ISBN: 978 0 580 94994 4
• Status: Standard

Why This Standard Matters

The BS ISO 18250-6:2019 standard is designed to ensure that connectors used in neural applications are safe, reliable, and compatible with existing systems. This is particularly important in the field of neurology, where precision and reliability are critical. The standard provides guidelines that help prevent misconnections and ensure that the connectors function as intended, thereby reducing the risk of medical errors and enhancing patient safety.

Applications in Healthcare

Reservoir delivery systems are widely used in healthcare settings for the administration of medications and other therapeutic agents. In neural applications, these systems are crucial for delivering precise doses to specific areas of the nervous system. The BS ISO 18250-6:2019 standard ensures that the connectors used in these systems are designed to meet the rigorous demands of neural applications, providing healthcare professionals with the confidence they need to deliver effective care.

Benefits of Compliance

Compliance with the BS ISO 18250-6:2019 standard offers numerous benefits, including:

• Enhanced Safety: By adhering to the guidelines set forth in the standard, manufacturers can ensure that their connectors are safe for use in neural applications, minimizing the risk of adverse events.
• Improved Compatibility: The standard promotes the development of connectors that are compatible with a wide range of reservoir delivery systems, facilitating seamless integration into existing healthcare infrastructures.
• Regulatory Approval: Products that comply with the BS ISO 18250-6:2019 standard are more likely to meet regulatory requirements, streamlining the approval process and accelerating time-to-market.

Who Should Use This Standard?

The BS ISO 18250-6:2019 standard is an invaluable resource for a variety of stakeholders in the healthcare industry, including:

• Medical Device Manufacturers: Companies involved in the design and production of connectors for reservoir delivery systems can use this standard to ensure their products meet the highest safety and performance standards.
• Healthcare Providers: Hospitals, clinics, and other healthcare facilities can rely on the standard to select connectors that are safe and effective for use in neural applications.
• Regulatory Bodies: Agencies responsible for the approval and oversight of medical devices can use the standard as a benchmark for evaluating the safety and efficacy of connectors used in neural applications.

Conclusion

The BS ISO 18250-6:2019 standard is a critical tool for ensuring the safety and effectiveness of connectors used in reservoir delivery systems for neural applications. By providing clear guidelines and specifications, this standard helps manufacturers produce high-quality products that meet the needs of healthcare providers and patients alike. Whether you are a manufacturer, healthcare provider, or regulatory body, the BS ISO 18250-6:2019 standard is an essential resource for ensuring the highest standards of safety and performance in neural applications.

BS ISO 18250-6:2019

This standard BS ISO 18250-6:2019 Medical devices. Connectors for reservoir delivery systems for healthcare applications is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters

The word neural has been used as a more generic term as neuraxial only relates to the central nervous system and not the peripheral nervous system.

This document does not specify how this outlet port connector is attached to the reservoir, neither does it concern itself with any other reservoir ports necessary to make the reservoir work, e.g. air inlets, nor does it specify how the reservoir is sealed to prevent ingress of contaminants. These requirements are left to the manufacturers as they do not affect the misconnection of the reservoir outlet with a giving set of another application.