YY/T 0347-2009Particular specifications for mini medical diagnostic X-ray equipment (English PDF)

Foreword

Instead of the standard YY/T 0347-2002 "mini-medical diagnostic X-ray machine general technical conditions." Compared with the standard YY/T 0347-2002 The main changes are as follows.

--- Safety requirements should be changed to comply with GB 9706.1, GB 9706.3, GB 9706.11, GB 9706.12, GB requirements of 9706.14. Removed Appendix A;

--- Modify the standard name, the "mini-medical diagnostic X-ray machine general technical conditions" to "micro-diagnostic X-ray machine designed Technical conditions ";

--- Because YY/T 91055-1999 "paint coating medical devices classified technical conditions" obsolete, the reference standard delete this standard;

--- Remove the 5.12 Environmental test methods in Table 1;

--- Remove the inspection rules, manual, signs, labeling requirements, packaging, transportation and storage;

--- Modified tube voltage deviation, tube current deviation, load time deviation test methods;

--- Supplementary radiation leakage under Article loading conditions;

--- Effective field of view display size to the size of the effective field of vision;

--- The focus skin distance from the screen to focus and focus skin distance;

--- Adds additional shield requirements.

1 Scope

This standard specifies the miniature diagnostic X-ray machine (hereinafter referred to as microcomputer) terms and definitions, classification and composition, requirements and test method.

This standard applies to facilitate tube current image with the receiver in the following 1000µA portable medical diagnostic X-ray machine.

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 9706.3-2000 Medical electrical equipment - Part 2. High-voltage generator safety device requirements for diagnostic X-ray generator (Idt IEC 60601-2-7:1998)

GB 9706.11-1997 Medical electrical equipment - Part II. diagnostic X-ray source assemblies and X-ray tube assemblies Requirements (idt IEC 60601-2-28:1993)

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/T 10149 X-ray equipment for medical terminology and symbols

YY 0076-1992 metal parts coating technology classification conditions

YY/T 0106-2008 medical diagnostic X-ray machine general technical conditions

YY/T 0291-2007 medical X-ray equipment environmental requirements and test methods

YY 0292.1-1997 Medical Diagnostic X-ray radiation protection appliances - Part 1. Determination of attenuation properties of materials (idt IEC 1331-1.

1994)

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

5 Requirements