This International Standard specifies requirements and test methods for sterile syringes, with or without
needles, solely for the injection of insulin. The syringes are single-use only, primarily for use 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 Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.