In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (First revision) (ISO 15193:2009, IDT)
This Malaysian Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
This Malaysian Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
This Malaysian 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.
Published
• (none) / (none) / MS ISO 15193:2008
PDF
17/01/2021
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NSC 18 - Medical Devices and Facilities for Healthcare
