YY/T 1531-2017 (YY/T1531-2017, YYT 1531-2017, YYT1531-2017) & related versions
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Biochemical identification systems for bacteria
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YY/T 1531-2017: PDF in English (YYT 1531-2017)
YY/T 1531-2017
Biochemical identification systems for bacteria
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Bacterial biochemical identification system
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The release of this document
The agency does not assume responsibility for identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing Institute, Thermo Fisher Scientific (China) Co., Ltd., Changsha, Hunan, earth and animal
Technology Co., Ltd., BD Medical Devices (Shanghai) Co., Ltd., Shandong Xin Branch Biological Technology Co., Ltd., Shanghai Star Bai Biotechnology
Limited company.
The main drafters of this standard. Bi Chunlei, Jiangdan Dan, Zhang Maolin, Yang Zhong, Zhang Rui, Pang Chao, Zhang Yuejian.
Bacterial biochemical identification system
1 Scope
This standard specifies the requirements of bacterial biochemical identification system, test methods, labels and instructions for use, packaging, transportation and storage.
This standard applies to the use of biochemical identification of bacteria on the clinical level of identification of instruments and identification reagents. Instruments include semi-self
Moving, automatic bacterial identification equipment (hereinafter referred to as instruments), reagents include identification plate, identification card, identification of identification reagents (hereinafter referred to as
Reagent).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes
Special requirements for moving and semi-automatic equipment
GB/T 14710 medical electrical environment requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 26. Particular requirements for body
External diagnostic (IVD) medical equipment
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 3. PROFESSIONAL IN VITRO DIAGNOSIS INSTRUMENTS
YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
The special requirements
3 requirements
3.1 identification accuracy
With known strains tested, the identification results should be consistent with the known bacteria name.
3.2 Identification of repeatability
Quality control strains were tested repeatedly, the identification results obtained should be the same.
3.3 Repeatability between reagents
With quality control strains of three batches of reagents for testing, the identification results obtained should be the same.
3.4 reagent stability
Quality control strains of near-term detection of reagents, identification results should be consistent with the name of known bacteria.
......
| Standard ID | YY/T 1531-2017 (YY/T1531-2017) | | Description (Translated English) | Biochemical identification systems for bacteria | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,876 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Device Inspection Institute, Thermo Fisher Scientific (China) Co., Ltd., Hunan Changsha Tiandiren Biotechnology Co., Ltd., BD Medical Devices (Shanghai) Co., Ltd., Shandong Xin Branch Biotechnology Co., Ltd., Shanghai Xing Bai Biotechnology Co., Ltd | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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