1 Scope
This standard specifies the classification, composition, requirement and test method of medical angiography X-ray equipment (hereinafter referred to as angiography equipment) that has the function of interventional procedures.
This standard is applicable to X-ray equipment which is stated by the manufacturer and is suitable for long-time fluoroscopic guidance and interventional procedures.
2 Normative References
The provisions in the following documents, through reference in this standard, constitute the provisions of this standard. For dated reference, subsequent amendments (excluding corrigendum), 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 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 (IEC 60601-2-7: 1998, IDT)
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 1-1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems (IEC 60601-1-1: 2000, IDT)
GB 9706.23-2005 Medical Electrical Equipment - Part 2-43: Particular Requirements for the Safety of X-ray Equipment for Interventional Procedures (IEC 60601-2-43: 2000, IDT)
GB/T 10151-2008 Medical Diagnostic X-ray Equipment - Specifications for High Voltage Cable Plugs and Sockets
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 Test - Imaging Performance of X-ray Equipment for Radiographic and Radioscopic Systems (IEC 61223-3-1: 1999, IDT)
GB/T 19042.3-2005 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-3: 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 Environmental Requirements and Test Methods for Medical X-ray Equipment
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)
3 Terms and Definitions
For the purposes of this standard, the terms and definitions specified in GB/T 10149, GB/T 19042.1-2003, GB/T 19042.3-2005 and GB 9706.23-2005 as well as those listed below apply.
3.1
Imaging time
The period required from the beginning of exposure to the display of normal image on the screen.
3.2
Stabilization of image brightness
The automatic control capacity which may keep an invariable image brightness under different degenerative phantom.
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification and Composition
5 Requirements
6 Test Methods
Appendix A (Normative) Test Layout
Appendix B (Normative) Test Phantom
