标准摘要
[中文适用范围]： 本文件规定了制造商设计的专用一次性抽空和非抽空容器的要求和测试方法，用于主要容纳和保存来自人体的样本（血液样本除外），用于体外试验。 诊断检查。 它无意于覆盖用于法医调查的样本容器。 此类样本的例子包括但不限于脑脊液(CSF)、粪便、受感染的体液、唾液、精液、痰液、尿液、组织样本。 特别排除的样本和设备类型是用于冷冻保存的专用容器、用于核酸检测的样本和拭子。 注：ISO 6710 规定了抽空和非抽空一次性人体静脉血标本采集容器的要求和测试方法。 本文件没有规定与标本容器配合使用的辅助装置的要求。 [外文原描述]： 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. Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples. Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs. NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710. This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.
英文名称In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood