This standard specifies classification and composition as well as requirements and test methods for mobile C-arm X-ray equipment (hereinafter referred to as C-arm X-ray equipment).
This standard is applicable to the X-ray equipment equipped with mobile C-arm mechanical support device and this product is mainly used for the positioning and inspection by medical institutes in the surgery.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
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 9706.15-2008 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical Systems (IEC 60601-1-1: 2000, IDT)
GB/T 10149 Terminology and Symbol for Medical X-ray Equipment
GB/T 10151-2008 Medical Diagnostic X-ray Equipment - Specifications for High Voltage Cable Plugs and Sockets
GB/T 19042.1-2008 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Tests - Imaging Performance of X-ray Equipment for Radiography and Radioscopic Systems (IEC 61223-3-1: 1999, IDT)
GB/T 19042.3-2005 Evaluation and Routine Testing in Medical Imaging Departments - Part3-3: Acceptance Tests - Imaging Performance of X-ray Equipment for Digital Subtraction Angiography (DSA) (IEC 61223-3-3: 1996, IDT)
YY 0076-1992 Coating Classifications for Metal Product - Technical Conditions
YY/T 0106-2008 General Specifications for Medical Diagnostic X-ray Equipment
YY/T 0291-2007 The Environmental Requirements and Test Methods for Medical X-ray Equipment
YY 0605-2005 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility Requirements and Tests (IEC 60601-1-2: 2001, IDT)
3 Terms and Definitions
For the purpose of this standard, the terms and definitions established in GB/T 10149, GB/T 19042.1-2003 and GB/T 19042.3-2005 apply.
4 Classification and Composition
4.1 Classification
According to the classification by product structure, it belongs to the mobile equipment.
4.2 Composition
C-arm X-ray equipment shall be composed of X ray generator system, mobile C-arm support frame and X-ray image system at least.
