本文件规定了标称容量为1 ml及以上的无菌一次性皮下注射器的要求，该注射器由塑料材料制成，旨在与电动注射泵一起使用。 本文件不适用于具有自动禁用注射器功能的注射器（ISO 7886-3[2]）、用于胰岛素的注射器（ISO 8537[3]）、玻璃制成的一次性注射器、制造商预充注射器以及作为药剂师灌装套件随注射器一起提供的注射器。它没有解决与注射流体的兼容性。

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3^[2]), syringes for use with insulin (ISO 8537^[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.