YY/T 1143-2008Bridge type impedance blood flow recorder (English PDF)

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--- Update outdated reference standard.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

YY/T 1143 is the product standard for the bridge-type impedance rheograph, an instrument that infers blood flow from changes in the electrical impedance of a body segment as blood volume varies through the cardiac cycle. It is the bridge-circuit counterpart of the direct-measurement instrument covered by YY/T 1078, and the two standards were issued together. Impedance methods remain in use in China for peripheral and cerebral blood flow assessment, and their measurements depend on electrode arrangement, excitation current and the signal processing that separates a small pulsatile change from a large baseline. For a manufacturer or a distributor of impedance rheography equipment for the Chinese market, this is the standard the type testing follows.

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 200Omega 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.