ISO 8537:2007

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

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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.


General information

  • Current status : Withdrawn
    Publication date : 2007-10
  • Edition : 2
  • :
    ISO/TC 84
    Devices for administration of medicinal products and catheters
  • 11.040.25
    Syringes, needles and catheters

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