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YY/T 1191-2011: Antimicrobial susceptibility test disks
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1191-2011 | English | 209 |
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Antimicrobial susceptibility test disks
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YY/T 1191-2011
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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 | 9,952 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State 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---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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.
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