YY/T 1244-2014: Purified water for in vitro diagnostic reagents

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Scope

This Standard specifies terms and definitions, requirements, and test methods of
purified water in-vitro diagnostic reagents.
Purified water for in-vitro diagnostic reagents can be used for in-vitro diagnostic
reagents’ production, general reagent preparation in medical laboratory, instrument
and equipment cleaning etc.
If there are special requirements for reagents production, REFER to the relevant
standards or FORMULATE a special requirement (such as the special requirements
for particle by blood cell counting reagents; the special requirements for DNA
enzymes, RNA enzymes, and protease by molecular biology reagents).

Basic Data

Standard ID	YY/T 1244-2014 (YY/T1244-2014)
Description (Translated English)	Purified water for in vitro diagnostic reagents
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	6,634
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	PRC Pharmacopoeia 2010 edition (Volume 2)
Adopted Standard	PRC Pharmacopoeia 2010 edition (Volume 2)
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 production of in vitro diagnostic reagents, reagent preparation general medical laboratories, instruments and equipment cleaning with purified water. When reagents production have special requirements, refer to the relevant st