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YY/T 1244-2014 (YYT 1244-2014)

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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 & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 6,611
Date of Issue 2014/6/17
Date of Implementation 2015/7/1
Quoted Standard PRC Pharmacopoeia 2010 edition (Volume 2)
Adopted Standard PRC Pharmacopoeia 2010 edition (Volume 2)
Drafting Organization Beijing Medical Device Testing
Administrative Organization National medical clinical laboratory testing and in vitro diagnostic systems Standardization Technical Committee
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Proposing organization State Food and Drug Administration
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


YY/T 1244-2014: PDF in English (YYT 1244-2014)
YY/T 1244-2014
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Purified water for in vitro diagnostic reagents
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Requirements ... 4 
5 Test methods ... 5 
References ... 7 
Foreword
This Standard was drafted according to the rules given by GB/T 1.1-2009.
Please note that some contents of this Document may involve patents. The issuing
authority of this document does not undertake the responsibility for the identification of
these patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of the Standardization Technical
Committee of National Medical Clinical Test Laboratory and in Vitro Diagnostic
System (SAC/TC 136).
Main drafting organizations of this Standard. Beijing Institute of Medical Device
Testing, Beckman Coulter Experimental System (Suzhou) Co., Ltd., BIOSINO
Biotechnology Co., Ltd., Zhongshan University Da’an Gene Co., Ltd., and National
Institutes for Food and Drug Control.
Main drafters of this Standard. Bi Chunlei, Chen Xingbao, Wang Jianqing, Gao Xunian,
and Huang Jie.
Purified water for in vitro diagnostic reagents
1 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).
2 Normative references 
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrections) or revisions do not apply to this Standard.
Pharmacopoeia of the People's Republic of China 2010 Edition (Volume II)
3 Terms and definitions 
The following terms and definitions apply to this document.
3.1
purified water
This product is the water obtained from drinking water by distillation method,
ion-exchange method, reverse-osmosis method or other suitable methods, without
any additives.
4 Requirements 
4.1 Characters
This product shall be clear and colorless liquid.
References
[1] GB/T 6682-2008 Water for analytical laboratory use - Specification and test
methods
[2] National Pharmacopoeia Committee. Pharmacopoeia of the People's Republic of
China 2010 Edition (Volume II)
[3] CLSI (C3-A4 2006). Preparation and test of water for clinical laboratory reagents
Approved guideline. 4th Edition.
[4] ISO 3696.1987 Water for analytical laboratory use - Specification and test
methods
......