ISO 8537:2007
Sterile single-use syringes, with or without needle, for insulin
- Standard No.
- ISO 8537:2007
- Release Date
- 2007
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 8537:2016
- Latest
- ISO 8537:2016
- 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.
ISO 8537:2007 Referenced Document
- ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
- ISO 7864:1993 Sterile hypodermic needles for single use
- ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods*， 2016-08-01 Update
ISO 8537:2007 history
- 2016 ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
- 2007 ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin
- 2000 ISO 8537:1991/Amd 1:2000 Sterile single-use syringes, with or without needle, for insulin, Amendment 1
- 1991 ISO 8537:1991 Sterile single-use syringes, with or without needle, for insulin
