標準號：BS EN ISO 15193-2009
中文標準名稱：體外診斷醫療器械.生物源樣品的數量測量.基準測量規程的內容和表示要求
英文標準名稱：In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
標準類型：C38
發布日期：2009/5/31 12:00:00
實施日期：2009/5/31 12:00:00
中國標準分類號：C38
國際標準分類號：11.100.10
引用標準：ISO 15194;ISO/IEC GUIDE 98-3-2008;ISO/IEC GUIDE 99-2007
適用范圍：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.