BS ISO 18250-7:2018 - Medical Devices: Connectors for Reservoir Delivery Systems for Healthcare Applications

In the ever-evolving world of healthcare, ensuring the safety and efficiency of medical devices is paramount. The BS ISO 18250-7:2018 standard is a crucial document that addresses the specifications and requirements for connectors used in reservoir delivery systems, specifically for intravascular infusion. Released on December 20, 2018, this standard is an essential resource for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and implementation of medical connectors.

Comprehensive Coverage

Spanning 40 pages, the BS ISO 18250-7:2018 standard provides a detailed framework for the design and testing of connectors used in medical devices. It ensures that these connectors meet the necessary safety and performance criteria, thereby minimizing the risk of misconnections and enhancing patient safety. The document is meticulously structured to cover all aspects of connector design, from material selection to dimensional specifications and performance testing.

Key Features and Benefits

• Standard Number: BS ISO 18250-7:2018
• ISBN: 978 0 580 95285 2
• Status: Standard
• Release Date: December 20, 2018

The BS ISO 18250-7:2018 standard is designed to ensure compatibility and interoperability among different medical devices, which is critical in a healthcare setting where multiple devices are often used in conjunction. By adhering to this standard, manufacturers can guarantee that their products will work seamlessly with other devices, reducing the likelihood of errors and improving overall patient care.

Why This Standard Matters

Intravascular infusion is a common medical procedure that involves the delivery of fluids, medications, or nutrients directly into a patient's bloodstream. The connectors used in these systems must be reliable and safe to prevent any potential harm to patients. The BS ISO 18250-7:2018 standard provides the necessary guidelines to ensure that these connectors are designed and manufactured to the highest standards.

By following the specifications outlined in this standard, manufacturers can produce connectors that are not only safe and effective but also compliant with international regulations. This compliance is crucial for gaining market access and ensuring that products meet the expectations of healthcare providers and patients alike.

Ensuring Patient Safety

One of the primary goals of the BS ISO 18250-7:2018 standard is to enhance patient safety by reducing the risk of misconnections. Misconnections can lead to serious medical errors, including the administration of incorrect fluids or medications. By providing clear guidelines for connector design and testing, this standard helps to prevent such errors and ensures that patients receive the correct treatment.

The standard also emphasizes the importance of using high-quality materials in the production of connectors. This focus on material quality ensures that connectors are durable, reliable, and capable of withstanding the rigors of medical use. By prioritizing material quality, the standard helps to extend the lifespan of connectors and reduce the need for frequent replacements, ultimately saving time and resources for healthcare providers.

Global Relevance

The BS ISO 18250-7:2018 standard is recognized internationally, making it a valuable resource for manufacturers and healthcare providers around the world. By adhering to this standard, companies can ensure that their products are accepted in global markets, facilitating international trade and collaboration in the healthcare industry.

Furthermore, the standard's global recognition means that it is continually updated and refined to reflect the latest advancements in medical technology and practices. This commitment to continuous improvement ensures that the standard remains relevant and effective in addressing the evolving needs of the healthcare sector.

Conclusion

In summary, the BS ISO 18250-7:2018 standard is an indispensable tool for anyone involved in the design, production, or use of medical connectors for intravascular infusion. With its comprehensive guidelines and focus on safety and performance, this standard plays a critical role in enhancing patient care and ensuring the reliability of medical devices.

Whether you are a manufacturer looking to ensure compliance with international regulations or a healthcare provider seeking to improve patient safety, the BS ISO 18250-7:2018 standard is an essential resource that can help you achieve your goals. By investing in this standard, you are taking a proactive step towards improving the quality and safety of healthcare delivery systems worldwide.

BS ISO 18250-7:2018

• 11.040.25 Syringes, needles and catheters

This document specifies the interface dimensions and requirements for the design and functional performance of connectors intended to be used to connect intravascular infusion sets to intravascular infusion reservoirs.

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

EXAMPLES Medical devices which may use intravascular reservoir connectors are the following:

• Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets;

• Devices intended to be connected in series between the administration port of IV fluid reservoirs and the mating spikes of IV administration/giving lines;

• Syringes and syringe IV sets utilizing Luer connectors.

The following connectors are excluded from the scope of this document:

• Stoppers for bottles as specified in ISO 8536‑2;

• Compounding/admixture ports on IV reservoirs and intended mating devices.

  EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the compounding or admixture ports).

• The fill ports of non-powered (i.e. elastomeric) pumps.

NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes.

NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into intravascular infusion medical devices or accessories, even if not currently required by the particular medical device standards. It is expected that when the particular medical device standards are revised, requirements for reservoir connectors, as specified in ISO 18250, will be included.