YY/T 1078-2008Direct impedance blood flow recorder (English PDF)

Foreword

This standard is YY 91078-1999 "Direct ICG instrument" revision. This standard YY 91078-1999 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 tests" execution;

--- Environmental testing requirements modified to press GB/T 14710-1993 "Medical electrical equipment environmental requirements and test methods" execution;

--- Delete the original standard technical requirements for non-technical content 2.1,

--- Update outdated reference standard. From the date of implementation of this standard, YY 91078-1999 repealed. 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:

--- ZBC39002-1986;

--- YY 91078-1999. Direct ICG instrument

1 Scope

YY/T 1078 is the product standard for the direct impedance rheograph, which measures the impedance of a body segment directly rather than through a bridge circuit to derive blood flow from the pulsatile change in blood volume. It is the companion to YY/T 1143, covering the bridge-type instrument, and the two were issued on the same day. The performance of either depends on how the excitation current is applied, how the electrodes are placed, and how the instrument extracts a small periodic signal from a much larger static impedance. For a manufacturer or a distributor of impedance rheography equipment serving Chinese hospitals, this is the standard the type testing is run against.

This standard specifies the basic parameters of the instrument, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage requirements. The instrument is mainly used for brain, limbs, internal organs and other flow imaging examination, diagnosis for use of clinical or physiological research. This standard applies to direct blood flow impedance analyzer (hereinafter referred to as the instrument).

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 Basic parameters

3.1 Warm-up time. 2min.

3.2 Continuous working time. >=6h.

3.3 tracings recorded the most significant. >= ± 20mm. 4. Technical Requirements

4.1 Instrument Operating Conditions Ambient temperature. 5 °C ~ 40 °C; Relative humidity. <=80%; Atmospheric pressure. 860hPa ~ 1060hPa; Power supply. AC 220V ± 22V, 50Hz ± 1Hz;

4.2 Input impedance Instrument input impedance is not less than 40kOmega.

4.3 base impedance Z0

4.3.1 Z0 measuring range. 5Omega ~ 100Omega.

4.3.2 Z0 measurement error of ± 4%. 4.4.1 DeltaZ. 0 ~ 0.4Omega;

4.5.1 Maximum sensitivity 4.5.1.1 DeltaZ file. >=20mm/0.1Omega;