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
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This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-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.