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ISO 8537:2007

Sterile single-use syringes, with or without needle, for insulin

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.

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International Organization for Standardization [iso]

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