This International Standard specifies requirements and test methods for sterile syringes with or without needles intended for single use solely for the in-jection of insulin and primarily in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).
Sterile syringes specified in this International Stan-dard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.