1 Scope
This standard specifies terms, classification, requirements and test methods for mammographic x-ray equipment (hereinafter referred to as mammographic equipment).
This standard is applicable to mammographic x-ray equipment equipped with x-ray film intensifying screen and operated in contact and amplify way, which is special for medical units for mammographic X-ray photography.
This standard is not applicable to special accessories such as digital imaging devices, biopsy plates and stereotaxic devices.
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 5579-1985 High-voltage Cable Plug and Socket Connections for Medical X-ray Equipment
GB 9706.1-1995 Medical Electrical Equipment - Part 1: General Requirements for Safety (IEC 60601-1: 1988, 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 9706.24-2005 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, TDT)
GB/T 10149-1988 Terminology and Symbol for Medical X-ray Equipment
GB/T 17006.9-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 2-10: Constancy Tests - X-ray Equipment for Mammography (IEC 61223-2-10: 1999, IDT)
GB/T 19042.2-2005 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment (IEC 61223-3-2: 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 purpose of this standard, the terms and definitions established in GB/T 10149-1988 and the following ones apply.
3.1
Gantry for radiography
It refers the equipment used for supporting components such as the head of X-ray tube.
3.2
Compression device
It refers to the special devices used for compressing mamma on the mammographic equipment, including compression plates, supports for patients and devices for controlling the compression movement etc.
3.3
Compression plates
It refers to transparent plates used for compressing mammas of patients on the mammographic equipment.
4 Classification and Composition
4.1 Classification
Mammographic equipment may be divided into fixed type and movable type according to product structure.
4.2 Composition
Mammographic equipment at least shall be equipped with the following main components:
a) X ray generator system;
b) Gantry for radiography.
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification and Composition
5 Requirements
6 Test Methods
