标准摘要
[中文适用范围]： 本文件规定了验证空的无菌一次性皮下注射器设计的要求和测试方法，该注射器有或没有针头，由塑料或其他材料制成，用于最终用户填充后抽吸和注射液体。 本文件没有提供批签发的要求。 注射器主要用于人类。 本文件中指定的无菌注射器旨在填充后立即使用，不适合长时间容纳药物。 它不包括与胰岛素一起使用的注射器（参见 ISO 8537）、由玻璃制成的一次性注射器、与电动注射泵一起使用的注射器、制造商预填充的注射器以及打算在填充后储存的注射器（例如在由药剂师填写的试剂盒）。 本文件中指定的不带针头的皮下注射器旨在与 ISO 7864 中指定的皮下注射针头一起使用。 [外文原描述]： ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.
英文名称Sterile hypodermic syringes for single use — Part 1: Syringes for manual use