ISO 8537:2007 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 ISO 8537:2007 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.
Status : WithdrawnPublication date : 2007-10
Edition : 2Number of pages : 23
Technical Committee:Devices for administration of medicinal products and catheters