ISO 8537 Sterile, Single-Use Syringes for Insulin

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ISO 8537 Sterile, Single-Use Syringes for Insulin

ISO 8537 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 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.