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    WS 399-2012 - 中外标准 - - 2012/12 - 现行
    本标准规定了血液的储存要求。 本标准适用于一般血站和医疗机构的血液储存。
    血液储存血站医疗机构
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    WS/T 400-2012 - 中外标准 - - 2012/12 - 现行
    本标准规定了临床输注用血液的运输要求。
    血液运输临床输注采供血机构采供血场
  • CNS 14194-1998 - 中外标准 - - 1998/8 - 现行
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    YY 0053-2016 - 中外标准 - - 2016/3 - 现行
    本标准规定了在人体上使用的血液透析器,血液透析滤过器,血液滤过器和血液浓缩器的技术要求,在本文中涉及的“器件”特指上述产品。 本标准不适用于: ——体外循环血液管路; ——血浆分离器; ——血液灌注装置; ——血管通路装置; ——血泵; ——体外循环血液管路的压力监测器; ——空气监测器; ——制备、供给和监控透析液的系统; ——用于进行血液透析、血液滤过或血液透析滤过治疗的系统; ——再处理步骤和设备。 注:血液透析器、血液透析滤过器和血液滤过器的体外循环血液管路的要求按照YY 0267-2016的规定。
  • ISO 8637-2010 - 中外标准 - - 2010/7 - 作废
    ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
    血液定义耐久性渗析尺寸体外的血液透析过滤器血液透析器血透析设备血液过滤器处理惰性气体铠装电弧焊作标记医疗设备医学科学规范试验测试痕量元素分析BloodBlood cleansingDefinitionsDialysisDimensionsExtracorporealHaemodiafiltrationHaemodialysersHaemodialysis equipmentHaemofiltrationMarkingMedical equipmentMedical sciencesSpecificationsTesting
  • BS EN 1283-1996 - 中外标准 - - - 现行
    This European Standard specifies requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans. This European Standard does not apply to extracorporeal circuits for cardiovascular use or to other extracorporeal blood exchange devices, such as plasmafilters, haemoperfusion devices, vascular access devices, oxygenators, active medical devices or devices for peritoneal dialysis.
    性能试验血液学试验设备漏泄试验使用说明浓缩器流体入口压力试验医疗设备过滤器无菌设备人工器官血液可处置的尺寸管道配件人工肾流体控制设备(医疗)生物滤器过滤渗析流体排出口Blood-line systemsBloodlinesDefinitionDefinitionsDialyzerDisposableDisposable deviceEquipment for single useFiltersFiltrationHaemodiafiltrationHaemodialysersHaemodialysisHaemofiltrationInformationMarkingMeasurementMedical equipmentMedical instrumentsMedical sciencesMedical technologyMedical vacuum-pipeline servicesPerformance specificationPhysical propertiesSpecification (approval)Testing
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    YY 0327-2002 - 中外标准 - - 2002/1 - 现行
    本标准规定了用于人体血液在体外进行紫外线辐照处理的一次性使用紫外线透疗血液容器的要求及试验方法等。 本标准适用于以医用高分子材料制成的一次性使用紫外线透疗血液容器。
    医疗器械血液容器透疗紫外线透疗一次性容器
  • CNS 14193-1998 - 中外标准 - - 1998/8 - 现行
  • ISO 8638-2010 - 中外标准 - - 2010/7 - 作废
    ISO 8638:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
    血液循环系统定义耐久性渗析尺寸体外的血液透析过滤器血液透析器血透析血透析设备血液过滤器处理惰性气体铠装电弧焊作标记机械性能医疗设备医学科学云母板包装件压力补偿保护设备规范无菌试验测试痕量元素分析BloodBlood cleansingCirculatory systemDefinitionsDialysisDimensionsExtracorporealHaemodiafiltrationHaemodialysersHaemodialysisHaemodialysis equipmentHaemofiltrationMarkingMechanical propertiesMedical equipmentMedical sciencesPackagesPressure compensationProtection devicesSpecificationsSterilityTesting
  • ISO 8638-2004 - 中外标准 - - 2004/10 - 作废
    ISO 8638:2004 specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. ISO 8638:2004 is not applicable to haemodialysers, haemodiafilters or haemofilters, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysing fluid, or systems intended to perform haemofiltration or haemoconcentration. Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
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