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YY/T 1682-2019: Ureaplasma spp. /Mycoplasma hominis culture and antimicrobial susceptibility testing kit
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1682-2019 | English | 199 |
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Ureaplasma spp. /Mycoplasma hominis culture and antimicrobial susceptibility testing kit
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YY/T 1682-2019
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Basic data | Standard ID | YY/T 1682-2019 (YY/T1682-2019) | | Description (Translated English) | Ureaplasma spp. /Mycoplasma hominis culture and antimicrobial susceptibility testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,130 | | Date of Issue | 2019-10-23 | | Date of Implementation | 2021-10-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, labels, instructions for use, packaging, transportation and storage of Ureaplasma/Mycoplasma hominis culture and drug susceptibility test kits. This standard is only applicable to the culture and drug susceptibility detection kits (including separate culture identification kits) of Ureaplasma spp. The drug susceptibility coincidence rate test in this standard is not applicable to a separate culture kit. | YY/T 1682-2019: Ureaplasma spp. /Mycoplasma hominis culture and antimicrobial susceptibility testing kit
---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.
Ureaplasma spp./Mycoplasma hominis culture and antimicrobial susceptibility testing kit
ICS 11.040.40
C40
People's Republic of China Pharmaceutical Industry Standard
Ureaplasma/Mycoplasma hominis culture and drug sensitivity
Detection kit
Published on October 23,.2019
2021-10-01 implementation
Published by the State Drug Administration
Contents
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirement 1
5 Test method 4
6 Labels and instruction manuals 5
7 Packaging, transportation, storage 5
Appendix A (informative) Ureaplasma/Mycoplasma hominis culture and growth performance verification method for drug sensitivity test kits6
Reference 7
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the Standardization Technical Committee for In vitro Diagnostic Systems (SAC/TC136).
The main drafting organizations of this standard. China Food and Drug Inspection and Research Institute, Henan Medical Device Inspection Institute, Shandong Medical Device Product Quality
Inspection Center, Zhengzhou Antu Biological Engineering Co., Ltd., Zhengzhou Dianshi Biotechnology Co., Ltd.
Division, Zhuhai Lizhu Reagent Co., Ltd., Zhuhai Yinke Medical Engineering Co., Ltd., Merieux Diagnostic Products (Shanghai) Co., Ltd.,
Barrett Biotechnology (Zhengzhou) Co., Ltd.
The main drafters of this standard. Yu Ting, Zhang Juanli, Wang Haitao, Huang Jie, Qu Shoufang, Wang Wenqing, Wang Zeyu, Qin Junling, Zhang Baohua, Zheng Hongxia,
Liu Jieyou, Zeng Minxia, Zeng Bingbing, Wang Lingling, and Li Cuixia.
Ureaplasma/Mycoplasma hominis culture and drug sensitivity
Detection kit
1 Scope
This standard specifies the requirements, test methods, labels, and instructions for Ureaplasma/Mycoplasma hominis culture and drug sensitivity detection kits.
Books, packaging, transportation and storage.
This standard only applies to Ureaplasma p. And Mycoplasma humanis based on discoloration caused by biochemical reactions during culture.
(Mycoplasmahominis, MH) culture and drug sensitivity detection kits (including separate culture identification kits, collectively referred to as.
Kit).
The drug sensitivity compliance test in this standard does not apply to individual culture kits.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 Packaging, storage and transportation icon
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use
Pharmacopoeia of the People's Republic of China
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Minimuminhibitoryconcentration; MIC
The lowest concentration of an antimicrobial drug that inhibits visible growth of microorganisms in agar or broth dilution drug sensitivity tests.
3.2
Colourchangeunit; CCU
The minimum inoculation amount that can cause discoloration of the culture medium is to express the relative content of microorganisms.
3.3
Colonyforming unit; CFU
When counting live cultures, colonies formed by the growth of a single bacterial body or multiple bacterial bodies aggregated on a solid medium to
It expresses the number of live bacteria.
4 Requirements
4.1 Appearance
The kit should be complete, the internal and external packaging should be complete, the label should be clear, the liquid reagent should be uniform, no precipitation, clarification, and no leakage.
The appearance is in accordance with the properties specified by the manufacturer and should be clarified after dissolution.
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