本标准规定了制造商打算用于主要容纳和保存来自人体的血液标本以外的标本的一次性疏散和非抽真空的容器的要求和测试方法，用于体外诊断检查。 注1:真空和未抽空的一次性使用静脉血样本容器的要求和试验方法见prEN 14820。 注2:尽管样品容器应设计成避免内装物自然排放，但打开时，本标准并未规定试验程序，因为不可能进行客观和可重复的试验。 本标准没有规定采样针或针头或其他与样品容器配合使用的附件的要求

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 prEN 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.