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YY/T 1191-2011

Chinese Standard: 'YY/T 1191-2011'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1191-2011English179 Add to Cart Days<=3 Antimicrobial susceptibility test disks Valid YY/T 1191-2011
YY/T 1191-2011Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY/T 1191-2011 (YY/T1191-2011)
Description (Translated English) Antimicrobial susceptibility test disks
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 9,954
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard YY/T 0466.1
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from) State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the antimicrobial susceptibility paper General technical requirements for quality inspection. Including terminology and definitions, requirements, test methods, labeling and instructions for use, packaging, transportation and storage. Wherein the antimicrobial agent is a chemical synthesis of antibiotics and antibacterial agents collectively. This standard applies to medical laboratories for disk diffusion susceptibility testing Antimicrobial susceptibility used paper (hereinafter referred to as susceptibility paper).

YY/T 1191-2011
Antimicrobial susceptibility test disks
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Antimicrobial susceptibility paper
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
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 State 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, Becton Dickinson Medical Devices (Shanghai) Co., Ltd.
The main drafters of this standard. Bi Chunlei, a small section of mine, Duhai Ou.
Antimicrobial susceptibility paper
1 Scope
This standard specifies the general technical requirements for antimicrobial susceptibility paper quality inspection. Including the terms and definitions, requirements, test methods, labeling
And instructions for use, packaging, transportation and storage. Wherein the antimicrobial agent refers collectively antibiotics and synthetic antibacterial agents. This standard applies to doctors
Laboratory conducted disk diffusion susceptibility test used antibacterial agent susceptibility paper (hereinafter referred to as susceptibility paper).
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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Containing a predetermined amount of one or more circular pieces of paper antibacterial agents for disk diffusion susceptibility test to measure clinical pathogens to antimicrobial
In vitro susceptibility agent.
3.2
Zone diameters zonediameter
In the disk diffusion method in antimicrobial susceptibility paper around the bacterial growth is inhibited diameter annular area (mm).
Note. YY/T 0688.2-2010/ISO 20776-2.2007, definitions 3.15.
3.3
Acceptable range acceptablerange
In the disk diffusion susceptibility tests, quality control Bacilli relevant technical standards required ring diameter range.
Note. The relevant technical standards such as CLSI/NCCLSM100.
4 Requirements
4.1 Appearance
Appearance should meet the following requirements.
a) susceptibility paper packaging integrity, without damage; the appearance should be neat, clear identification text symbols;
b) susceptibility paper rounded edges no gaps, smooth surface, no cracks;
Name c) both sides have antimicrobial susceptibility paper of abbreviations and represents a number of antimicrobial agent content.
4.2 diameter paper
Susceptibility paper should have a diameter. 6.3mm ± 0.3mm.
Related standard:   YY/T 1182-2020  YY/T 1196-2013
Related PDF sample:   YY/T 1182-2020  YY/T 1197-2013
   
 
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