YY/T 1143-2008 English PDF

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YY/T 1143-2008: Bridge type impedance blood flow recorder
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1143-2008	229	Add to Cart	3 days	Bridge type impedance blood flow recorder	Valid

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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: 10,171
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Older Standard (superseded by this standard): YY 91143-1999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

---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.
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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