标准摘要
[中文适用范围]: 本文件规定了标称容量 1 毫升及以上、由塑料材料制成并与动力驱动注射泵一起使用的无菌一次性皮下注射器的要求。 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、预填充注射剂的注射器制造商和注射器随注射剂一起提供,作为药剂师填充的套件。 它不涉及与注射液的兼容性。 [外文原描述]: 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.
英文名称Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps