ISO 8537:2016规定了空的、无菌的一次性注射器的要求和测试方法，该注射器由塑料材料制成，且仅用于注射胰岛素，注射器由最终用户填充。本国际标准涵盖仅用于人体和各种浓度胰岛素的一次性注射器。 本国际标准中规定的胰岛素注射器旨在在灌装后立即使用（即胰岛素注射），且不打算长期含有胰岛素。 ISO 8537:2016不包括由玻璃制成的一次性注射器、与电动注射器泵一起使用的注射器、由制造商预先填充的注射器以及填充后储存的注射器（例如，在供药剂师填充的试剂盒中）。

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).