BS ISO 18250-1:2018 - 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 18250-1:2018 standard is a crucial document that sets the benchmark for connectors used in reservoir delivery systems within healthcare applications. Released on December 5, 2018, this standard provides comprehensive guidelines and common test methods to ensure that these connectors meet the highest quality and safety standards.

Overview of BS ISO 18250-1:2018

The BS ISO 18250-1:2018 standard is a part of a series of standards that focus on medical devices, specifically the connectors used in reservoir delivery systems. These systems are integral to various healthcare applications, including intravenous therapy, enteral feeding, and other critical medical procedures. The standard outlines the general requirements and common test methods that these connectors must adhere to, ensuring their reliability and safety in medical settings.

Key Features and Benefits

• Comprehensive Guidelines: The standard provides detailed guidelines on the design, performance, and testing of connectors, ensuring they meet the necessary safety and quality requirements.
• Enhanced Safety: By adhering to the BS ISO 18250-1:2018 standard, manufacturers can ensure that their connectors minimize the risk of misconnections, which can lead to serious medical errors.
• Consistency and Compatibility: The standard promotes consistency in the design and functionality of connectors, facilitating compatibility across different medical devices and systems.
• Global Recognition: As an ISO standard, BS ISO 18250-1:2018 is recognized internationally, making it easier for manufacturers to market their products globally.

Technical Specifications

The BS ISO 18250-1:2018 standard is a comprehensive document spanning 62 pages. It is identified by the standard number BS ISO 18250-1:2018 and carries the ISBN 978 0 580 90579 7. The document is currently in standard status, indicating its active role in guiding the development and testing of medical device connectors.

Importance in Healthcare

Connectors play a critical role in the functionality of reservoir delivery systems. These systems are used to deliver fluids and medications to patients, making the reliability of connectors a matter of life and death. The BS ISO 18250-1:2018 standard ensures that these connectors are designed and tested to prevent leaks, misconnections, and other potential hazards that could compromise patient safety.

By following the guidelines set forth in this standard, healthcare providers can trust that the connectors they use are of the highest quality, reducing the risk of adverse events and improving patient outcomes. This standard is not only a tool for manufacturers but also a reassurance for healthcare professionals and patients alike.

Common Test Methods

The standard outlines a series of common test methods that are essential for verifying the performance and safety of connectors. These tests include:

• Leakage Testing: Ensures that connectors do not allow fluid to escape, which could lead to contamination or incorrect dosing.
• Connection Strength Testing: Verifies that connectors can withstand the forces they may encounter during use without failing.
• Compatibility Testing: Confirms that connectors are compatible with other components of the reservoir delivery system, preventing misconnections.

Conclusion

The BS ISO 18250-1:2018 standard is an essential resource for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and use of medical device connectors. By adhering to this standard, stakeholders can ensure that their products meet the highest safety and quality standards, ultimately enhancing patient care and safety.

Whether you are a manufacturer looking to ensure compliance or a healthcare provider seeking reliable products, the BS ISO 18250-1:2018 standard is an invaluable tool in the pursuit of excellence in healthcare delivery systems.

BS ISO 18250-1:2018

• 11.040.25 Syringes, needles and catheters

This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient.

This document also specifies the healthcare fields in which these reservoir connectors are intended to be used.

These healthcare fields of use include, but are not limited to, applications for

• respiratory,

• enteral,

• neural,

• intravascular,

• citrate-based anticoagulant solution, and

• irrigation.

Reservoir connectors as specified in this document are non-interconnectable with:

• the reservoir connectors of every other application specified in the ISO 18250 series;

• removable temperature sensor port specified in Annex EE of ISO 80601‑2‑74:2017;

• the nipples specified in Annex B of ISO 17256¹;

unless otherwise specified in the ISO 18250 series.

Application parts of the ISO 18250 series can specify additional connectors with which reservoir connectors (as specified in those application parts) are to be non-interconnectable.

This document provides the methodology to assess non-interconnectable characteristics of reservoir connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications.

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

NOTE 1 Manufacturers are encouraged to incorporate the reservoir connectors specified in the ISO 18250 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for reservoir connectors as specified in the series of standards will be included.

NOTE 2 The ISO 18250 series does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. Examples of screw caps and necks are defined in DIN 55525, ASTM D2911/D2911M, DIN 6063‑1, DIN 6063‑2, DIN 168‑1. Examples of crown cork caps and necks are defined in DIN 6094, ISO 12821, EN 14635.

This document also specifies the test methods to verify the common performance requirements for reservoir connectors. The performance requirements for these common test methods are specified in the application parts and not in the general part.

¹ Under preparation. Stage at the time of publication: ISO/DIS 17256:2017.