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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.
Life cycle
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Previously
WithdrawnISO 8537:1991
WithdrawnISO 8537:1991/Amd 1:2000
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Now
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Revised by
PublishedISO 8537:2016