標準號：BS EN ISO 7886-3-2009
中文標準名稱：一次性使用無菌皮下注射器.固定劑量免疫接種用自動報廢注射器
英文標準名稱：Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization
標準類型：C31
發布日期：2009/11/30 12:00:00
實施日期：2009/11/30 12:00:00
中國標準分類號：C31
國際標準分類號：11.040.25
引用標準：ISO 3696-1987;ISO 7864-1993;ISO 7886-1-1993;ISO 8537-1991;ISO 9626;ASTM D999-2001;ASTM D5276-1998
適用范圍：This part of ISO 7886 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 isautomatically rendered unusable.This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer.This part of ISO 7886 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.NOTE A fourth part of ISO 7886 is being prepared to cover syringes with reuse prevention feature.