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YY/T 0738-2009 English PDF

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YY/T 0738-2009: particular specification for cardiovascular table
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 0738-2009169 Add to Cart 3 days particular specification for cardiovascular table Valid

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Basic data

Standard ID: YY/T 0738-2009 (YY/T0738-2009)
Description (Translated English): particular specification for cardiovascular table
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.50
Word Count Estimation: 7,723
Date of Issue: 2009-11-15
Date of Implementation: 2010-12-01
Quoted Standard: GB 9706.1-2007; GB 9706.12-1997; GB 9706.14-1997; GB 9706.23-2005; GB/T 10149; YY 0076-1992; YY/T 0291-2007; YY 0505-2005
Regulation (derived from): Industry standard filing Notice 2010 No. 2 (No. 122 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies: Medical X-ray catheter bed (hereinafter referred to as the catheter bed) classification and composition, requirements and test methods. This standard applies to the catheter bed. These products can be equipped with a medical X-ray imaging device, Check for interventional radiology and surgical treatment. This standard does not apply to intervene in the operation of X-ray angiography system comes conduit bed.

YY/T 0738-2009: particular specification for cardiovascular table

---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.
particular specification for cardiovascular table ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards Medical X-ray catheter bed special technical conditions Posted 2009-11-15 2010-12-01 implementation State Food and Drug Administration issued

Foreword

The standard safety requirements for full implementation of GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" and GB 9706.14-1997 "Medical electrical equipment - Part 2. X-ray equipment ancillary equipment requirements for the safety." This standard by the National Standardization Technical Committee on Medical Electrical medical X-ray equipment and utensils Standardization Technical Committee (SAC / TC10/SC1) centralized. This standard was drafted. Liaoning Provincial Medical Device Testing. The main drafters of this standard. Mou Li, Pan Zhenzi, one hundred real Liu, Dong Kai I. Medical X-ray catheter bed special technical conditions

1 Scope

This standard specifies the medical X-ray catheter bed (hereinafter referred to as the catheter bed) classification and composition, requirements and test methods. This standard applies to the catheter bed. Such products can be used with medical X-ray imaging equipment for interventional radiology examination and treatment surgery. This standard does not apply to interventional procedures X-ray angiography system comes with a catheter bed.

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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety. Collateral standard diagnostic X-ray equipment General requirements for radiation protection (idt IEC 60601-1-3.1994) GB 9706.14-1997 Medical electrical equipment - Part 2. X-ray equipment ancillary equipment requirements for the safety (idt IEC 60601-2-32.1994) GB 9706.23-2005 Medical electrical equipment - Part 2-43. Interventional X-ray equipment operating requirements for the safety (IEC 60601-2-43.2000, IDT) GB/T 10149 X-ray equipment for medical terminology and symbols YY 0076-1992 metal parts coating technology classification conditions YY/T 0291-2007 medical X-ray 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

Terms and definitions GB/T 10149 apply to this standard established.

4 Classification and composition

4.1 Classification Press mechanical structure can be divided into mobile and fixed. 4.2 Composition Catheter bed bed panel should at least, the bed and the control device components.

5 Requirements

5.1 Working conditions 5.1.1 Environmental conditions Unless otherwise specified, working conditions should be met. a) Ambient temperature. 10 ℃ ~ 40 ℃; b) Relative humidity. 30% to 75%; c) Atmospheric Pressure. 700hPa ~ 1060hPa.
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