GB/T 19702-2021: In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

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Scope

This 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 Standard can be expected to produce
measurement results with a measurement uncertainty not exceeding the stipulated
interval.
This Standard applies to reference measurement procedures providing values
of differential or rational quantities. Annex A provides information on nominal
properties and ordinal quantities.
This 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 Standard, “international measurement standard” designates a material
standard. The term “international standard” is used by WHO for reference materials.

Basic Data

Standard ID	GB/T 19702-2021 (GB/T19702-2021)
Description (Translated English)	In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Word Count Estimation	22,242
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration