This standard specifies terms and definitions, classification and composition, requirements, test methods, inspection rules, marking, labelling, operation instruction, packaging, transport and storage of digital medical X-ray image detector used in general radiography (hereinafter referred to as detector).
This standard is applicable to the detector with the function of imaging in single exposure, including, but not limited to, amorphous silicon detector, amorphous selenium detector, CCD detector, CMOS detector, etc.
This standard is not applicable to:
——detector used in mammography or dental photography;
——detector used in computed tomography;
——detector used for dynamic imaging.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 9706.1-2007 Medical Electrical Equipment - Part 1: General Requirements for Safety
GB/T 10149-1988 Terminology and Symbol for Medical X-ray Equipment
YY/T 0291-2007 Environmental Requirements and Test Methods for Medical X-ray Equipment
YY/T 0481-2004 Medical Diagnostic X-ray Equipment - Radiation Conditions for Use in the Determination of Characteristics
YY 0505-2012 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standards: Electromagnetic Compatibility - Requirements and Tests
YY/T 0590.1-2005 Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices - Part 1: Determination of the Detective Quantum Efficiency
YY/T 0590.2-2010 Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices - Part 1-2: Determination of the Detective Quantum Efficiency - Detectors Used in Mammography
YY/T 0708-2009 Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
YY/T 0741-2009 General Specifications for Digital Medical X-ray Radiography System
YY/T 1099-2007 Marking, Packaging, Transportation and Storage for Medical X-ray Equipment
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in YY/T 0590.1-2005, YY/T 0590.2-2010, YY/T 0741-2009, GB/T 10149-1988 and YY/T 0481-2004 and the following apply.
