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YY/T 0656-2008: Automated Blood Culture System
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0656-2008 | English | 209 |
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Automated Blood Culture System
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YY/T 0656-2008
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PDF similar to YY/T 0656-2008
Standard similar to YY/T 0656-2008 YY/T 0659 YY/T 0653 YY/T 0654 YY/T 0655 Basic data | Standard ID | YY/T 0656-2008 (YY/T0656-2008) | | Description (Translated English) | Automated Blood Culture System | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,961 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Quoted Standard | GB 4793.1; GB/T 14710 | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the automated blood culture system terms, definitions, requirements, test methods, marking, labeling and instructions, packaging, transportation and storage. This standard applies to the clinical laboratory in vitro culture, detection of human blood or other sterile fluid under normal conditions (hereinafter referred to as sterile body fluids) in the automated blood culture systems of microorganisms (hereinafter referred to as blood culture systems), including blood culture apparatus and its supporting medium. The scope of this standard is referred to microbial bacteria and yeast-like fungi. | YY/T 0656-2008: Automated Blood Culture System---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.
Automated Blood Culture System
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Automated blood culture systems
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
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 is mainly drafted by. American BD Company, bioMerieux, France, Beijing Medical Device Testing.
The main drafters of this standard. Tong Mingqing, Shen Ran, Wang Hui, XIAO Zhi-qiang.
Automated blood culture systems
1 Scope
This standard specifies the automated blood culture system of terms, definitions, requirements, test methods, marking, labeling and instructions, packaging, transport and
Storage.
This standard applies to clinical laboratories through in vitro, detect human blood under normal conditions or other sterile body fluid (hereinafter referred to as no
Bacteria humoral) automated blood culture system of microorganisms (hereinafter referred to as the blood culture system), and the apparatus comprises a blood culture medium supporting.
The scope of the standard within the meaning of micro-organisms are bacteria and yeast-like fungi.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 4793.1 measurement, control and laboratory use safety requirements for electrical equipment - Part 1. General requirements
GB/T 14710 Medical electrical equipment environmental requirements and test methods
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Clinical laboratory by in vitro detection of human blood or other body fluids in sterile microorganisms.
3.2
For in vitro human blood or other body fluids in sterile microbiological medium.
3.3
Clinical laboratory in vitro human blood or other body fluids in a sterile microbial continuous culture, automatically detect and determine the culture knot
Fruit (positive or negative) of the system, which includes a blood culture system and its supporting medium.
3.4
Blood culture system detects blood culture medium in the presence of microorganisms.
3.5
In the culture period, blood culture system failed to detect blood in the culture medium with the presence of microorganisms.
3.6
Blood culture system determines a positive blood culture, but transferred after staining and no species of microorganisms present.
3.7
Blood culture system determines blood culture negative, but after staining and transferred species found in the presence of microorganisms.
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