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  • ISO 10993-4-2002 - 中外标准 - - - 现行
    This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
    生物试验相互作用外科植入物血液医疗设备导则生物测定分类牙科学牙科器械牙科设备医学科学外科设备医疗产品定义材料试验BioassayBiological hazardsBiological testsBloodClassificationDefinitionsDental equipmentDental instrumentsDentistryEvaluationsGuidelinesHaematologyImplants (surgical)In vitroInteractionMaterialsMedical devicesMedical equipmentMedical productsMedical sciencesRiskSpecification (approval)Surgical equipmentSurgical implantsTesting
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    GB 8369-2005 - 中外标准 - - 2005/7 - 现行
    本标准规定了一次性使用医用输血器的要求,以保证与血液血液成分容器和静脉器具相适应。  本标准的第二个目的是为输血器所用材料的性能及质量规范提供指南,并给出了输血器组件的标记。
    输血设备尺寸一次性使用输血器规范blood transfusion equipmentspecificationssize contentsizesspecificationdimensionaldimensionssize
  • DIN 58913-1-2000 - 中外标准 - - - 现行
    The document is applicable to the determination of factor II and factor X coagulant activity in plasma and factor concentrates by the one-stage method. The purpose of this document is to achieve comparable results for the factor II C and factor X C content in a given specimen. Essential precondition for archieving this objective are a standardized procedure for calibration of the method, as well as the use of reference plasmas or reference concentrates with declared factor II C and factor X C proportion, respectively, which has been determined by calibration against the International Standard of WHO for factor II C and factor X C, respectively, which is valid at the time of use.#,,#
    化学分析和试验多语种的分析测定定义试验医学科学人用的药物血液血浆实验室医学等离子成分凝结血凝固止血学一段法血细胞计数凝血剂活性血液学bloodhaematologychemical analysis and testingblood countsdefinitiondeterminationmultilingualplasmablood coagulationcoagulationhaemostaseologyone-stage methodplasma fractioncoagulant activityblood plasmatestinghuman medicineanalysismedical scienceslaboratory medicinedefinitions
  • ISO 8637-2010/Amd 1-2013 - 中外标准 - - 2013/4 - 作废
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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
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    YY/T 0653-2017 - 中外标准 - - 2017/3 - 现行
    本标准规定了血液分析仪的术语和定义、产品分类、技术要求、试验方法、标签、标记、使用说明、包装、运输和贮存要求。本标准适用于对人类血液中有形成分进行分析,并提供相关信息的血液分析仪。本标准不适用于网织红细胞项目检测。
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    YY 0314-2007 - 中外标准 - - 2007/7 - 现行
    医疗器械血液静脉聚集容器医疗MEDICAL INSTRUMENTSMEDICAL DEVICESBLOODHAEMATOLOGYVEINSCONTAINERSVESSELSTANKSMEDICAL TREATMENT
  • ISO 13958-2002 - 中外标准 - - 2002/9 - 作废
    This International Standard is applicable to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or haemodiafiltration. It addresses chemical quality and purity, microbial contamination, handling, measurement and labelling of concentrates, the requirements for containers and the tests to monitor concentrates. This International Standard does not address the final mixing and use of these concentrates and treated water in such therapies. That operation is the sole responsibility of dialysis professionals. This International Standard is not applicable to dialysing-fluid regeneration systems.
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    YY/T 0168-2007 - 中外标准 - - 2007/7 - 现行
    血液冷藏箱冰箱COOLING EQUIPMENTBLOOD STORAGEBLOODHAEMATOLOGYMEDICAL EQUIPMENTCOLD STORAGE
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    YY/T 0617-2007 - 中外标准 - - 2007/7 - 现行
    本标准规定了用于体外诊断检查的、制造商预期一次性使用、采血量不超过1 000 μL的人体末梢血样采集采血管的要求和试验方法。本标准不包括静脉血样采集容器和动脉血样采集器的要求。
    医学医疗器械人体血液样品采样设备容器MEDICINEMEDICAL INSTRUMENTSMEDICAL DEVICESHUMAN BODYCLAYBLOODHAEMATOLOGYDUMMYSPECIMENSSAMPLESAMPLING EQUIPMENTCONTAINERSVESSELSTANKS
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