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  • BSI
    BS EN ISO 15193:2009 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
    Edition: 2016
    $435.35
    / user per year

Description of BS EN ISO 15193:2009 2016

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.



Standard NumberBS EN ISO 15193:2009
TitleIn vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
StatusUnder Review
Publication Date2016-01-31
ReplacesBS EN 12286:1999
Identical National Standard OfEN ISO 15193:2009, ISO 15193:2009
CorrectsBS EN ISO 15193:2009
DescriptorsStatistical methods of analysis, Accuracy, Data processing, Clinical investigation instruments, Medical equipment, Layout, Laboratories, Terminology, Diagnosis (medical), Samples, Safety measures, Reliability, Biological analysis and testing, Precision, Documents, Calibration, Measurement, Quality assurance, Reproducibility
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 92899 4
PublisherBSI
Pages30

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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