BS EN ISO 15193-2009 体外诊断医疗器械.生物源样品的数量测量.基准测量规程的内容和表示要求

标准号：BS EN ISO 15193-2009
中文标准名称：体外诊断医疗器械.生物源样品的数量测量.基准测量规程的内容和表示要求
英文标准名称：In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
标准类型：C38
发布日期：2009/5/31 12:00:00
实施日期：2009/5/31 12:00:00
中国标准分类号：C38
国际标准分类号：11.100.10
引用标准：ISO 15194;ISO/IEC GUIDE 98-3-2008;ISO/IEC GUIDE 99-2007
适用范围：This International Standard specifies requirements for the content of a reference measurement procedure forin vitro diagnostic medical devices and medical laboratories.NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written inaccordance with this International Standard can be expected to produce measurement results with a measurementuncertainty not exceeding the stipulated interval.This International Standard applies to reference measurement procedures providing values of differential orrational quantities. Annex A provides information on nominal properties and ordinal quantities.This International Standard is valid for any person, body or institution involved in one of the various branchesof laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.Full descriptions of measurement methods are usually published in scientific literature, in which methods aredescribed in sufficient detail that they can be used as the basis of a documented measurement procedure.NOTE 2 In this International Standard, “international measurement standard” designates a material standard. The term“international standard” is used by WHO for reference materials.