| ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 6-364 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Section 5.3 Colour coding. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5860 | Syringe, Piston | Class 2 | FMF |
| §880.5570 | Needle, Hypodermic, Single Lumen | Class 2 | FMI |
| Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes, Issued April 1993. |