ISO 7886-3:2005 一次性使用无菌皮下注射器 第3部分：固定剂量免疫用自失效式耳咽管

标准编号：ISO 7886-3:2005

中文名称：一次性使用无菌皮下注射器 第3部分：固定剂量免疫用自失效式耳咽管

英文名称：Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization

发布日期：2005-03

标准范围

ISO 7886-3:2005规定了一次性无菌皮下注射器的性能和性能，该注射器由塑料材料和不锈钢制成，用于吸入疫苗或灌装后立即注射疫苗。在提供固定剂量的疫苗后，注射器会自动变得无法使用。ISO 7886-3:2005未规定自动禁用功能的设计，这由制造商自行决定ISO 7886-3:2005不适用于胰岛素注射器（ISO 8537中规定）、玻璃注射器（ISO 595中规定）、电动注射泵注射器（ISO 7886-2中规定）、可变剂量自动禁用注射器和预填充注射器。它不涉及与注射液/疫苗的相容性。

ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturerISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

标准预览图