This standard specifies terms, classification and composition, requirements as well as test methods for the mobile radiography X-ray equipment (hereinafter referred to as X-ray equipment).
This standard is only applicable to X-ray equipment for special photography function powered by single phase A.C. power supply and/or internal power supply.
2 Normative References
The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending error in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of these documents is applicable. For undated references, the latest edition of the normative document is applicable to this standard.
GB 5579 High-voltage Cable Plug and Socket Connections for Medical X-ray Equipment
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: Particular Requirements for the Safety of High-voltage Generators of Diagnostic X-ray Generators (idt IEC 60601-2-7: 1998)
GB 9706.11-1997 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (idt IEC 60601-2-28: 1993)
GB 9706.12-1997 Medical Electrical Equipment - Part 1: General Requirements for Safety 3. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray equipment (idt IEC 60601-1-3: 1994)
GB 9706.14-1997 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment (idt IEC 60601-2-32: 1994)
GB/T 10149 Terminology and Symbol for Medical X-ray Equipment
GB/T 19042.1-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Tests - Imaging Performance of X-ray equipment for Radiographic and Radioscopic systems (IEC 61223-3-1: 1999, IDT)
YY 0505-2005 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility Requirements and Tests (IEC 60601-1-2: 2001, IDT)
YY 0076-1992 Coating Classifications for Metal Product - Technical Conditions
YY/T 0291-2007 The Environmental Requirements and Test Methods for Medical X-ray Equipment
3 Terms and Definitions
For the purpose of this standard, the terms and definitions in the GB/T 10149 apply.
4 Classification and Composition
4.1 Classification
The safety classification shall be in accordance with those specified in GB 9706.1-2007.
4.2 Composition
X-ray equipment at least shall be equipped with the following main components:
a) X ray generator system;
b) Mechanical support device.
5 Requirements
5.1 Operating conditions
5.1.1 Environment conditions
Unless otherwise specified, the operating environment of X-ray equipment shall meet the following conditions:
a) Environment temperature: 10℃~40℃;
b) Relative humidity: 30%~75%;
c) Atmospheric pressure: 700hPa ~1060hPa.
