The ISO 80369-7 standard, developed by the International Standards Organization (ISO), describes the properties and test methods of fasteners used for intravenous or subcutaneous applications. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80369-7 Small diameter fittings for liquids and gases in healthcare applications - Part 7: Fasteners for intravenous or hypodermic applications. This standard replaces the abolished TS 3521-1 EN 20594-1 standard.
This standard describes requirements for the design and functional performance of small-bore fasteners intended for use in connections in intravenous applications or connections in subcutaneous applications of medical devices and accessories. For example, subcutaneous syringes and needles, male and female luer slide fasteners, and intravenous cannulas with luer lock fasteners 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 using these connectors. Such requirements are contained in other international standards, particularly for certain medical devices or accessories. This standard also does not disclose the requirement 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 fittings (ISO 8637), and infusion system shutdown piercing fasteners (ISO 8536‑4).
Our organization also provides businesses with ISO 80369-7 testing services for intravenous or subcutaneous application fasteners as part of our laboratory services.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
