1 Scope
This standard specifies classification, requirements and test methods for medical diagnostic X-ray equipment (hereinafter referred to as "X-ray equipment").
This standard is applicable to medical diagnostic X-ray equipment. As for medical diagnostic X-ray equipment for which national or industry-specified standards are provided, the corresponding standards should be implemented.
This standard is not applicable to X-ray computed tomography equipment.
2 Normative References
The following documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction), 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 normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
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 9706.15-1999 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical Systems (idt IEC 60601-1-1: 1995)
GB 9706.23-2005 Medical Electrical Equipment - Part2-43: Particular Requirements for the Safety of X-ray Equipment for Interventional Procedures (IEC 60601-2-43: 2000, IDT)
GB 9706.24-2005 Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices (IEC 60601-2-45: 2001, IDT)
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification and Composition
5 Requirements
6 Test methods
