标准编号：ISO 8537:2016
中文名称：带或不带针头的一次性无菌胰岛素注射器
英文名称：Sterile single-use syringes, with or without needle, for insulin
发布日期：2016-03
标准范围
This International Standard specifies requirements and test methods for empty, sterile, single-usesyringes, with or without needles, made of plastic materials and intended solely for the injection ofinsulin, with which the syringes are filled by the end user. This International Standard covers syringesintended 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.This International Standard excludes single-use syringes made of glass, syringes for use with powerdrivensyringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to bestored after filling (e.g. in a kit intended for filling by a pharmacist).
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