BS EN 14254-2004 体外诊断医疗设备.取自于人体的不包括血液的样品用一次性容器

标准号：BS EN 14254-2004
中文标准名称：体外诊断医疗设备.取自于人体的不包括血液的样品用一次性容器
英文标准名称：In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
标准类型：C44
发布日期：2004/7/6 12:00:00
实施日期：2004/7/6 12:00:00
中国标准分类号：C44
国际标准分类号：11.100.10
适用范围：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 EN 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.