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Abstract

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 

  • Status
     :  Withdrawn
    Publication date
     : 2007-10
  • Edition
     : 2
    Number of pages
     : 23
  • Technical Committee
     : ISO/TC 84 Devices for administration of medicinal products and catheters
  • ICS
     :
    11.040.25 Syringes, needles and catheters

Life cycle


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