YY/T 1244-2014Purified water for in vitro diagnostic reagents (English PDF)

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.