医用输液设备.一次性使用的重力输液式输液器

标准编号：BS EN ISO 8536-4-2007

提出单位：BSI

起草单位：BSI

发布日期：2007年

实施日期：20070430

主      题：生物测定 生物试验 化学性质 兼容性 可混用性 名称与符号 可处置的 一次性使用设备 重力输液 检验 加标签 作标记 材料 医疗设备 医疗产品 医学科学 包装件 胃肠外注入设备 物理性能 安全 安全要求 规范 规范(验收) 测试 密封性 容积流量率 

中国标准分类号：C31

国际标准分类号：11_040_20

摘      要：This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.