YY/T 1244-2014 PDF English
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YY/T 1244-2014: Purified water for in vitro diagnostic reagents
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1244-2014YY 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... 7Foreword
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 reagents1 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.4 Requirements
4.1 Characters This product shall be clear and colorless liquid. 4.2 Conductivity Conductivity (25°C) shall not be more than 0.1 mS/m. 4.4 Total organic carbon Total organic carbon is not more than 500 g/L. 4.5 Easily oxidized materials TAKE 100mL of this product. ADD 10mL of dilute sulfuric acid (10%). After boiled, ADD 0.10mL of potassium permanganate titration solution (0.02 mol/L), then boiling for 10 min, the pink shall not disappear completely.5 Test methods
5.1 Characters INSPECTE visually by normal vision, it shall meet the requirements of 4.1. 5.2 Conductivity MEASURE with conductivity meter. It has temperature automatic compensation function. 5.4 Total organic carbon DETERMINE according to the determination method of total organic carbon in the Annex VIII R pharmaceutical water of "Pharmacopoeia of the People's Republic of China 2010 Edition (Volume II)". The results shall meet the requirements of 4.4. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
