ISO 8537 Sterile Single-Use Syringes, with or without Needle, for Insulin

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ISO 8537 Document Information:

Title
Sterile Single-Use Syringes, with or without Needle, for Insulin

International Organization for Standardization

Publication Date:
Oct 1, 2007

Scope:

This International Standard 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 this International Standard are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

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