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.
EN ISO 8537:2008 history
2016EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
2008EN ISO 8537:2008 Sterile single-use syringes, with or without needle, for insulin
1994EN ISO 8537:1994 Sterile Single-Use Syringes@ with or Without Needle@ for Insulin (Incorporates Amendment A1: 2000)