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YY/T 0738-2009Particular specifications for cardiovascular table (English PDF)

医用X射线导管床专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 25, 2009

Implementation date

December 1, 2010

Scope

YY/T 0738-2009 is the English-translated version of 医用X射线导管床专用技术条件.

YY/T 0738-2009 is the Chinese pharmaceutical industry standard that sets the particular technical requirements for medical X-ray cardiovascular tables, the catheter tables used with X-ray imaging equipment for interventional radiology examinations and procedures.

It classifies the tables as mobile or fixed, requires at least a table top, a base and a control device, and fixes the working conditions of ambient temperature, humidity, atmospheric pressure and power supply before setting out the requirements and test methods.

It applies the safety requirements of GB 9706.1 and GB 9706.14. It does not cover the catheter table supplied as part of an X-ray angiography system. Issued on 25 November 2009, it has applied since 1 December 2010.

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Document preview — YY/T 0738-2009

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C 43

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Classification and composition
  • 5 Requirements

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.

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 °C ~ 40 °C;

b) Relative humidity. 30% to 75%;

c) Atmospheric Pressure. 700hPa ~ 1060hPa.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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