体外诊断医疗设备.取自于人体的不包括血液的样品用一次性容器

标准编号：BS EN 14254-2004

提出单位：BSI

起草单位：BSI

发布日期：2004年

实施日期：20040706

主      题：医疗设备 插孔 实验室 容量 血的试验 定义 容器 在实验室条件下 医学科学 规范(验收) 试样 生物化学制品 利用 实验室医学 诊断(医学) 诊断 人用的药物 基准方法 可处置的 无菌 实验室条件下诊断 人员 样品 血细胞计数 一次性使用设备 标志 参考材料 使用说明 材料 

中国标准分类号：C44

国际标准分类号：11_100_10

摘      要：This standard specifies requirements and test methods for single-use evacuated and non-evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. NOTE 1 Requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers are specified in EN 14820. NOTE 2 While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test. This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.