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
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
This International Standard specifies requirements for the content of a reference measurement procedure for
in vitro diagnostic medical devices and medical laboratories.
NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in
accordance with this International Standard can be expected to produce measurement results with a measurement
uncertainty not exceeding the stipulated interval.
This International Standard applies to reference measurement procedures providing values of differential or
rational 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 branches
of 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 are
described 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.