BS EN 14136-2004 体外诊断检验程序的性能评定中外部质量评定方案的使用

标准号：BS EN 14136-2004
中文标准名称：体外诊断检验程序的性能评定中外部质量评定方案的使用
英文标准名称：Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
标准类型：C05
发布日期：2004/5/26 12:00:00
实施日期：2004/5/26 12:00:00
中国标准分类号：C05
国际标准分类号：11.100.10
适用范围：This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: — scheme design and organisation; — identification of procedures (IVD MDs) used by the participant; — classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.