BS EN ISO 7886-4-2009 一次性使用无菌皮下注射器.具有防止重复使用功能的注射器
【英文标准名称】: Sterile hypodermic syringes for single use - Syringes with re-use prevention feature 【原文标准名称】: 一次性使用无菌皮下注射器.具有防止重复使用功能的注射器 【标准号】: BS EN ISO 7886-4-2009 【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】: 医用套管;组件;定义;牙科设备;牙科学;设计;尺寸;可处置的;可处置物;一次性使用设备;消防泵;保健;皮下注射针头;喷射设备;注射器;联锁装置;钻模;加标签;标志;材料;医疗器械;医疗设备;医疗产品;医学科学;针;包装件;性能;塑料;电力输液器;一次性注射器;规范(验收);规范;消毒;无菌设备;测试【英文主题词】: Cannulas;Components;Definitions;Dental equipment;Dentistry;Design;Dimensions;Disposable;Disposables;Equipment for single use;Fire pumps;Health protection;Hypodermic needles;Injection equipment;Injection syringes;Interlocks;Jigs;Labelling;Marking;Materials;Medical devices;Medical equipment;Medical products;Medical sciences;Needles;Packages;Performance;Plastics;Power infusion apparatus;Single use syringes;Specification (approval);Specifications;Sterile;Sterile equipment;Testing【摘要】: This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics 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 part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), 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 part of ISO 7886.NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886.【中国标准分类号】: C31【国际标准分类号】: 11_040_25【页数】: 25P.;A4【正文语种】: 英语
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