ISO 7886 Sterile Hypodermic Syringes for Single Use

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ISO 7886 Sterile Hypodermic Syringes for Single Use

ISO 7886-1 specifies requirements (cleanliness, limits for acidity and alkalinity, limits for extractable metals, lubricant, tolerance on graduated capacity, graduated scale, barrel, piston/plunger assembly, nozzle, performance, packaging, labeling) for sterile single-use hypodermic syringes made of plastic materials and intended for the aspiration of fluids or for the injection of fluids immediately after filling. Excludes e.g. syringes for use with insulin, single-use syringes made of glass.

The ISO 7886-1 procedure uses the test machine to compress and expel water from syringes while measuring the force to move the syringe piston.

  • Depress the piston at a constant speed of 100 mm/min (4 in/min)
  • Measure and report initial, mean, and maximum force levels
  • Forces can approach 100 N (20 lbf)

ISO 7886-2 Sterile, Single-Use, Hypodermic Syringes for Use with Power-Driven Syringe Pump

ISO 7886-2 specifies requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven syringe pumps. Does not apply to syringes for use with insulin, single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a doctors kid.

ISO 7886-3 Sterile, Hypodermic, Auto-Disable Syringes for Fixed-Dose Immunization

ISO 7886-3 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable. ISO 7886-3 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.

ISO 7886-4 Sterile, Hypodermic Syringes with Re-Use Prevention Feature

ISO 7886-4 specifies requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.