ISO 7886-4:2006 无菌皮下注射器.第4部分：带防止重复使用功能的注射器

标准编号：ISO 7886-4:2006

中文名称：无菌皮下注射器.第4部分：带防止重复使用功能的注射器

英文名称：Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature

发布日期：2006-10

标准范围

ISO 7886-4:2006规定了一次性无菌皮下注射器的要求，该注射器由塑料材料制成，带或不带针头，用于吸入液体或填充后立即注射液体，其设计应确保注射器在使用后无法使用。ISO 7886-4:2006不适用于玻璃制成的注射器（ISO 595中有规定）、用于固定剂量免疫的自动禁用注射器（ISO 7886-3）和设计为预填充的注射器。它不涉及与注射液的相容性。当注射器用于ISO 7886规定以外的任何其他预期用途时，可适用其他标准-4:2006.注:设计用于降低针头刺伤风险的注射器也可以符合ISO 7886-4:2006关于其重复使用预防性能的规定，但需要强调的是，ISO 7886-4:2006中并未涉及注射器的抗针头刺伤性能。

ISO 7886-4:2006 specifies requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.ISO 7886-4:2006 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in ISO 7886-4:2006.NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with ISO 7886-4:2006 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in ISO 7886-4:2006.

标准预览图