BS EN ISO 7886-3-2009 一次性使用无菌皮下注射器.固定剂量免疫接
【英文标准名称】: Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization 【原文标准名称】: 一次性使用无菌皮下注射器.固定剂量免疫接种用自动报废注射器 【标准号】: BS EN ISO 7886-3-2009 【标准状态】: 现行 【国别】: 英国 【发布日期】: 2009-11-30 【实施或试行日期】: 2009-11-30【发布单位】: 英国标准学会(GB-BSI)【起草单位】: BSI【标准类型】: ()【标准水平】: ()【中文主题词】: 组件;定义;尺寸;可处置的;保健;注射器械;注射器;联锁装置;加标签;标志;医疗器械;医疗设备;医疗产品;医学科学;包装件;性能;塑料;动力输液器;一次性注射器;规范(验收);不锈钢;无菌设备;测试【英文主题词】: Components;Definitions;Dimensions;Disposables;Health protection;Injection instruments;Injection syringes;Interlocks;Labelling;Marking;Medical devices;Medical equipment;Medical products;Medical sciences;Packages;Performance;Plastics;Power infusion apparatus;Single use syringes;Specification (approval);Stainless steels;Sterile equipment;Testing【摘要】: 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.【中国标准分类号】: C31【国际标准分类号】: 11_040_25【页数】: 24P.;A4【正文语种】: 英语大家好，我新来的，谢谢主！！！！
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