DS/EN ISO 8537
Sterile single-use syringes, with or without needle, for insulin
| Organization: | DS |
| Publication Date: | 21 July 2008 |
| Status: | inactive |
| Page Count: | 38 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
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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