本文件规定了制造商拟用于体外诊断检查的人体样本（血液样本除外）主要密封和保存的专用一次性真空和非真空容器的要求和试验方法。其目的不是覆盖用于法医调查的样本容器。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, 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. It is not intended to cover specimen containers for forensic investigations.All current amendments available at time of purchase are included with the purchase of this document.