ISO 7886-4:2018 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 7886-4:2018

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：2018-11

标准范围

本文件规定了一次性使用无菌皮下注射器的要求，该注射器由塑料和橡胶材料制成，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。本文件不适用于[ISO 595（撤回）中规定的]玻璃制成的注射器、用于固定剂量免疫的自动禁用注射器（ISO 7886-3）以及设计为预填充的注射器。它不涉及与注射液的相容性。当注射器用于本文件规定以外的任何其他预期用途时，可适用其他标准。注:注射器设计用于降低针头感染的风险-关于防止再次使用的特性，刺伤也可以符合本文件的要求，但需要强调的是，本文件并未涉及注射器的防针刺伤特性。

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber 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can be rendered unusable after use.This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886？3) and syringes designed to be pre-filled.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 this document.NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

标准预览图