標準號：BS EN 14254-2004
中文標準名稱：體外診斷醫療設備.取自于人體的不包括血液的樣品用一次性容器
英文標準名稱：In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
標準類型：C44
發布日期：2004/7/6 12:00:00
實施日期：2004/7/6 12:00:00
中國標準分類號：C44
國際標準分類號：11.100.10
適用范圍：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.