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
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 is automatically 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.
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