ISO 8537 - Sterile single-use syringes, with or without needle, for insulin

The ISO 8537 standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user.

The following test methods are described:

• Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plunger
• Test method for determination of forces required to operate piston
• Test method for determination of dead space
• Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression
• Test method for air leakage past nozzle/hub or needle/barrel unions during aspiration