The ISO 7886-2 standard developed by the International Standards Organization (ISO) describes the characteristics and test methods of one-use subcutaneous syringes used with a power-driven syringe pump. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 7886-2 Syringes - Hypodermic - Single use sterile - Part 2: For use with a power driven syringe pump.
The said standard describes the requirements for disposable sterile syringes with a nominal capacity of 1 ml and above, made of plastic materials and designed for use with power-driven syringe pumps. This standard does not cover syringes that are covered by other international standards: syringes with auto-deactivate syringes (ISO 7886-3), syringes designed for use with insulin (ISO 8537), disposable glass syringes, and for filling by a pharmacist. syringes supplied with the injection as a kit. This standard also does not address compatibility with injection fluids.
The latest update to the ISO 7886-2 standard has added syringe sizes from 1 ml to 5 ml to its scope. The general flow rate requirement has been removed from the standard, as it is primarily affected by the syringe's inner diameter. Furthermore, pump test speeds have been revised for each syringe size to better reflect the speed range used in general clinical settings. The manufacturer of one of the syringe components used with the syringe pump must consider design changes and communicate with the other manufacturer. Specifically, they must provide information regarding tolerances and relationships between syringe dimensions and piston actuation force and performance characteristics.
Our organization also provides testing services for single-use subcutaneous syringes used with an ISO 7886-2 powered syringe pump, within the scope of laboratory services.
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