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Bridge type impedance blood flow recorder
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Basic data
| Standard ID | YY/T 1143-2008 (YY/T1143-2008) |
| Description (Translated English) | Bridge type impedance blood flow recorder |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C39 |
| Classification of International Standard | 11.040.50 |
| Word Count Estimation | 10,195 |
| Date of Issue | 2008-04-25 |
| Date of Implementation | 2009-06-01 |
| Older Standard (superseded by this standard) | YY 91143-1999 |
| Quoted Standard | GB/T 191-2008; GB 9706.1-2007; GB/T 14710-1993; YY 0505-2005 |
| Regulation (derived from) | SFDA [2008] No. 192 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies the terms and definitions of the instrument, the basic parameters, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage requirements. This standard applies to electrical bridge ICG instrument (hereinafter referred to as the instrument). The instrument is mainly used for the brain, limbs, internal organs such as blood flow examination for clinical diagnosis or physiological research. |
YY/T 1143-2008: Bridge type impedance blood flow recorder
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Bridge type impedance blood flow recorder
ICS 11.040.50
C39
People's Republic of China pharmaceutical industry standards
Replacing YY 91143-1999
Overhead electrical impedance blood flow meter
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is the recommended standard.
This standard replaces YY 91143-1999 "electrical bridge ICG instrument."
This standard YY 91143-1999 major differences are.
--- Safety requirements for the modification according to GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" and
YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and
Test "implementation.
--- Environmental testing requirements modified to press GB/T 14710-1993 "requirements and test methods for medical electrical equipment environment" implementation.
--- Delete the original standard technical requirements for non-technical content 3.1,3.10,3.19 ~ 3.22.
--- Update outdated reference standard.
This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard was drafted. Shanghai Medical Device detection.
The main drafters of this standard. and Yu.
This standard replaces the standards previously issued as follows.
--- WS2-309-1984;
--- YY 91143-1999.
Overhead electrical impedance blood flow meter
1 Scope
This standard specifies the terms and definitions of the instrument, the basic parameters, technical requirements, test methods, inspection rules and signs, packaging, transportation,
Storage requirements.
This standard applies to electrical bridge ICG instrument (hereinafter referred to as the instrument).
The instrument is mainly used for brain, limbs, internal organs and other flow imaging examination, diagnosis for use of clinical or physiological research.
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/T 191-2008 Packaging - Pictorial signs
GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2.2001, IDT)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Simulate the human body load
Access impedance instrument input 200Ω resistor in series with the capacitor 0.022μF as simulate the human load.
3.2
The best balance
When the instrument input of an analog of human access to the load, the adjustable impedance instrument bridge balance arm of the instrument to achieve the best balance, this time the bridge
Arm impedance called the best balance.
3.3
Worst balance
When the instrument input of an analog of human access to the load, the adjustable impedance instrument bridge balance arm of the instrument at the upper edge of the equilibrium range,
In this case the bridge arm impedance called the worst balance.
3.4
Working condition
When the instrument bridge balance, after access to a imbalance in impedance, the instrument enters the record or display the status of the waveform.
3.5
Top working condition
The instrument is the best balance into the working state.
3.6
Worst Job Status
The instrument is the worst balance Enter working condition.
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