ISO 18250-1 Medical Devices, Connectors for Reservoir Distribution Systems for Healthcare Applications, Part 1: General Requirements

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 18250-1 testing. This standard specifies general requirements for reservoir connectors that transport fluids in healthcare applications.

These reservoir connectors are used on medical devices or accessories intended for use with a patient. This standard also specifies the healthcare areas in which these reservoir connectors are intended to be used.

These healthcare uses include, but are not limited to:

• Respiratory,
• enteral,
• Neural,
• Intravenous,
• Citrate-based anticoagulant solution,
• Irrigation.

Application parts of the ISO 18250 series may specify additional fasteners with which the reservoir connections (as specified in these application parts) cannot be connected together.

This standard provides methodology for evaluating the non-interconnectable properties of reservoir connectors based on their structural design and dimensions to reduce the risk of misconnection between medical devices or accessories for different applications.

This standard does not specify requirements for medical devices or accessories that use these reservoir connectors. Such requirements are specifically given in International Standards for certain medical devices or accessories.

Manufacturers are recommended to include reservoir connectors specified in the ISO 18250 series in medical devices, medical systems or accessories, even if not currently required by the relevant specific medical device standards. When the relevant specific medical device standards are revised, it is expected that the requirements for reservoir connectors specified in the series of standards will be included.

This standard also specifies test methods to verify common performance requirements for reservoir connectors. Performance requirements for these common test methods are specified in the application sections, not the general section.

EUROLAB assists manufacturers with ISO 18250-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.