标准摘要
[中文适用范围]： 本文件规定了具有自动禁用注射器功能的无菌一次性皮下注射器的特性和性能，旨在在填充后立即输送固定剂量的疫苗。 注射器可以由塑料、橡胶或其他材料制成，并且可以具有或不具有针头和针头保护功能。 本文件没有指定自动禁用注射器功能的设计。 本文件不适用于与胰岛素一起使用的注射器（由 ISO 8537 涵盖）、与电动注射泵一起使用的注射器（由 ISO 7886-2 涵盖）、防止重复使用注射器（由与注射液/疫苗的兼容性涵盖）。 [外文原描述]： This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
英文名称Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization