1 Scope
This standard specifies the classification, naming and basic components, requirements as well as test methods of X-ray equipment for computed tomography (hereinafter referred to as CT scanning device).
This standard is applicable to X-ray equipment for computed tomography.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this national standard. For dated references, subsequent amendments (excluding contents of corrigenda) to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For any 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 "Medical Electrical Equipment-Part 1: General Requirements for Safety" (GB 9706.1-1995, idt IEC 60601-1: 1988)
GB 9706.11 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis" (GB 9706.11-1997, idt IEC 601-2-28: 1993)
GB 9706.12 "Medical Electrical Equipment-Part 1: General Requirements for Safety 3.Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment" (GB 9706.12-1997, idt IEC 60601-13: 1994)
GB 9706.14 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment" (GB 9706.14-1997, idt IEC 60601-2-32: 1994)
GB 9706.15 "Medical Electrical Equipment-Part 1: General Requirements for Safety 1.Collateral Standard: Safety Requirements for Medical Electrical Systems" (GB 9706.15-1999, idt IEC 60601-1-1: 1995)
GB 9706.18 "Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of X-ray Equipment for Computed Tomography" (GB 9706.18-2006, IEC 60601-2-44: 2002, IDT)
GB 10151 "Medical X-ray Equipment - Specifications for High Voltage Cable Plug and Socket"
GB/T 19042.5 "Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests-Imaging performances of computed tomography X-ray equipment" (GB/T 19042.5-2006, IEC 61223-3-5: 2004, IDT)
YY/T 0291 "Environmental Requirements and Test Methods for Medical X-ray Equipment"
3 Terms and Definitions
For the purposes of this standard, the terms and definitions established in GB 9706.18 and GB/T 19042.5 as well as the following one apply.
3.1
Artifact
The false image appearing in CT image, which is not an actual object.
4 Classification, Naming and Basic Components
4.1 The CT scanning device is subject to Type B equipment in Category I according to the protection type and protective degree against electric shock.
4.2 The naming rule is specified according to product standard.
4.3 Basic components; the CT scanning device is mainly composed of the following components:
a) Scanning frame;
b) X-ray generator;
c) Patient bracket;
d) Control console;
e) Computer image processing system.
If necessary, the available selective accessories shall be designated.
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification, Naming and Basic Components
5 Requirements
6 Test Methods
