YY/T 1244-2014 PDF English
US$85.00 · In stock · Download in 9 secondsYY/T 1244-2014: Purified water for in vitro diagnostic reagents Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1244-2014 | English | 85 |
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Purified water for in vitro diagnostic reagents
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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/YYT1244-2014
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.
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.
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