ISO 6717:2021 体外诊断医疗器械 从人类（血液除外）采集样本的一次性容器

标准编号：ISO 6717:2021

中文名称：体外诊断医疗器械 从人类（血液除外）采集样本的一次性容器

英文名称：In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

发布日期：2021-08

标准范围

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。此类样本的示例包括但不限于脑脊液（CSF）、粪便、受感染体液、唾液、射精、痰、尿液、组织样本。特别排除的样本和设备类型包括用于冷冻保存的专用容器、用于核酸检测的样本和拭子。注？疏散和非疏散设备的要求和试验方法-ISO？6710规定了一次性使用的真空人体静脉血液样本采集容器。本文件未规定与样本容器一起使用的辅助装置的要求。

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.

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