标准摘要
[中文适用范围]： 适用于装有或未装有针头的塑料胰岛素注射器，这些注射器专为人用且由最终用户填充。本标准涵盖 intendsd 供单次使用的胰岛素注射器及其浓度。 该国际标准不适用于玻璃制成的一次性使用注射器、与功率驱动注射器泵一起使用的注射器、制造商预装的注射器以及装满后打算储存的注射器（例如：由药剂师填充）。 [外文原描述]： 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).
英文名称Sterile single-use syringes, with or without needle, for insulin