DS/EN ISO 8537
Sterile single-use syringes, with or without needle, for insulin
| Organization: | DS |
| Publication Date: | 21 July 2008 |
| Status: | pending |
| Page Count: | 34 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
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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