本文件规定了一次性无菌皮下注射器的特性和性能，该注射器具有自动禁用注射器功能，用于在灌装后立即提供固定剂量的疫苗。注射器可以由塑料、橡胶或其他材料制成，可以带有或不带有针头和针头保护功能。 本文件未规定自动禁用注射器功能的设计。 本文件不适用于胰岛素注射器（ISO 8537涵盖）、电动注射泵注射器（ISO 7886涵盖）- 2） 、防止重复使用注射器（ISO 7886-4涵盖）或预填充注射器（ISO 11040系列涵盖）。它不涉及与注射液/疫苗的相容性。

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.