YY/T 1231-2014: Creatinine test reagent kit (Method of sarcosine oxidase)

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Scope

This standard specifies the technical requirements, test method, labeling, instructions
for use, packaging, transport and storage of creatinine test reagent (kit) (method of
sarcosine oxidase).
This standard applies to the creatinine test reagent (kit) that is used to carry out
quantitative determination of the creatinine concentration in serum, plasma and urine
with the method of sarcosine oxidase. It includes manual reagent and reagents used in
semi-automatic and full-automatic biochemical analyzer.
This standard does not apply to the creatinine test reagent (kit) with picric acid method.
This standard does not apply to the dry creatinine test reagent (kit).
2  Normative References
The following document is indispensable for the application of this Document. For dated
references, only dated edition applies to this document. For undated references, the
latest edition (including all amendments) applies to this document.
GB 3100 The international system of units and its application
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities
in biological samples - Metrological traceability of values assigned to calibrators and
control materials
YY /T 0316 Medical devices - Application of risk management to medical devices
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements

Basic Data

Standard ID	YY/T 1231-2014 (YY/T1231-2014)
Description (Translated English)	Creatinine test reagent kit (Method of sarcosine oxidase)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	11,151
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB 3100; GB/T 21415-2008; YY/T 0316; YY/T 0466.1
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to the use of sarcosine oxidase in serum, plasma, urine creatinine concentration quantitative detection of creatinine assay reagent (box), including manual reagents and on the semi-automatic biochemical analyzer used. This Standard s