YY/T 1244-2014 English PDF (YY/T1244-2014)

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YY/T 1244-2014: Purified water for in vitro diagnostic reagents
YY/T 1244-2014
Purified water for in vitro diagnostic reagents
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
In vitro diagnostic reagents with purified water
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Beckman Coulter experimental system (Suzhou) Co., biological Biosino
Technology Co., Ltd., Zhongshan Da An Gene Co., Ltd., China Institute of Food and Drug test.
The main drafters of this standard. Bi Chunlei, Chen Bao, GRAPHIC, Gao Xu years, Huang Jie.
In vitro diagnostic reagents with purified water
1 Scope
This standard specifies the use of purified water in vitro diagnostic reagents terms and definitions, requirements and test methods.
In vitro diagnostic reagents with purified water can be used for the production of in vitro diagnostic reagents, medical general laboratory reagent preparation, instruments and equipment cleaning.
Reagents production have special requirements, refer to the relevant standards or develop special requirements (for example, blood cell count reagent specific requirements for particles; points
Molecular biology reagents for DNA enzymes, RNA enzymes, protease special requirements, etc.).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
People's Republic of China Pharmacopoeia 2010 Edition (two)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Purified water purifiedwater
This product is drinking water by distillation, ion exchange, reverse osmosis or other suitable method to prepare, does not contain any water additives.
4 Requirements
4.1 Characters
This product should be a clear, colorless liquid.
4.2 Conductivity
Conductivity (25 ℃) should not exceed 0.1mS/m.
Note. Conductivity is the conductivity of the physical characterization of an object, which object is the resistivity (MΩ · cm) is the reciprocal of conductivity unit conversion formula is. 1mS/m
= 10μS/cm.
4.3 The total number of micro-organisms
Is not greater than the total number of microorganisms 50CFU/mL.
4.4 TOC
TOC of not more than 500μg/L.
4.5 Yi oxide
Take this product 100mL, add dilute sulfuric acid (10%) 10mL, after boiling, add potassium permanganate titration solution (0.02mol/L) 0.10mL, then boil