The ISO 80369-7 standard, developed by the International Organization for Standardization (ISO), specifies the dimensions and requirements for the design and functional performance of small bore connectors intended for use for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
Test methods according to ISO 80369-7 include:
The ISO 80369-7 standard specifies requirements for the design and functional performance of small-hole fasteners intended for use in connections in intravenous applications or in subcutaneous applications of medical devices and accessories.
For example, subcutaneous syringes and needles, male and female luer slip connectors, and intravenous cannulas with luer lock connectors are covered by this standard. The Luer fitting was originally designed for use at pressures up to 300 kPa.
The ISO 80369-7 standard does not specify requirements for medical devices or accessories that use these fasteners. Such requirements are contained in other international standards, particularly for certain medical devices or accessories.
This standard also does not specify requirements for the following small hole connectors covered by other international standards: hemodialyzer, hemodiafilter and hemofilter blood chamber ports (ISO 8637 and ISO 8638), hemodialysis, hemodiafiltration and hemofiltration equipment connectors (ISO 8637), and infusion system closure piercing fasteners (ISO 8536‑4).
Among the services provided by our organization within the framework of testing services for medical equipment, there are also ISO 80369-7 standard tests.
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