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现行 BS EN ISO 8536-14:2018
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Infusion equipment for medical use-Clamps and flow regulators for transfusion and infusion equipment without fluid contact 医用输液设备
发布日期: 2018-02-22
BS EN ISO 8536-14:2018规定了非无菌夹具和流量调节器的要求,这些夹具和流量调节器作为子部件,用于控制静脉注射溶液和/或血液成分在无液体接触的情况下通过无菌输液器、输血器和血袋组件的流量。在一些国家,国家药典或其他国家法规具有法律约束力,优先于ISO 8536的本部分。交叉引用:ISO 10993-1ISO 1135(所有部分)ISO 8536-4ISO 3826(所有部分)购买本文件时提供的所有当前修订版均包含在购买本文件中。
BS EN ISO 8536-14:2018 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.Cross References:ISO 10993-1ISO 1135 (all parts)ISO 8536-4ISO 3826 (all parts)All current amendments available at time of purchase are included with the purchase of this document.
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发布单位或类别: 英国-英国标准学会
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