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YY/T 1078-2008 English PDF

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YY/T 1078-2008: Direct impedance blood flow recorder
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PDF similar to YY/T 1078-2008


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Basic data

Standard ID YY/T 1078-2008 (YY/T1078-2008)
Description (Translated English) Direct 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 12,124
Date of Issue 2008-04-25
Date of Implementation 2009-06-01
Older Standard (superseded by this standard) YY 91078-1999
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 basic parameters of the instrument, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage requirements. The instrument is mainly used for the brain, limbs, internal organs such as blood flow examination for clinical diagnosis or physiological research. This standard applies to Direct ICG instrument (hereinafter referred to as the instrument).

YY/T 1078-2008: Direct 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.
Direct impedance blood flow recorder ICS 11.040.50 C39 People's Republic of China pharmaceutical industry standards Replacing YY 91078-1999 Direct ICG instrument Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

Table of Contents

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 basic parameters 1 4 technical requirements 5 Test Method 3 6 7 inspection rules 7 signs, packaging, transportation and storage 8

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 2.1,2.16 to 2.20. --- 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

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 ℃ ~ 40 ℃; 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 40kΩ. 4.3 base impedance Z0 4.3.1 Z0 measuring range. 5Ω ~ 100Ω. 4.3.2 Z0 measurement error of ± 4%. 4.4.1 ΔZ. 0 ~ 0.4Ω; 4.5 sensitivity 4.5.1 Maximum sensitivity 4.5.1.1 ΔZ file. ≥20mm/0.1Ω;

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