本文件为了体外诊断检查的目的，规定了制造商打算收集来自人体的静脉血标本的一次性容器的要求和试验方法。本文件也适用于含血培养基的容器。 本文件没有规定毛细血管样本容器或动脉血样本容器的要求。本文件没有规定用于收集除血液之外的标本的一次性容器的要求和测试方法

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture. This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.