This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, signs, labels, instructions for use, packaging, transportation and storage of detectors for medical breast digital X-ray photography (hereinafter referred to as "detectors"). This standard applies to detectors for breast digital X-ray equipment with single-exposure imaging functions, including but not limited to amorphous silicon detectors, amorphous selenium detectors, CCD detectors, CMOS detectors, etc. This standard does not apply to:
——detectors for general photography and detectors for dental photography;
——detectors for computed tomography;
——detectors for dynamic or tomographic imaging.
YY/T 1307-2016 Referenced Document
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*， 2020-04-09 Update
GB/T 10149 Terminology and symbol for medical X-ray equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0505 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
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/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 1099-2007 Packaging,transportation and storage for medical X-ray equipment
YY/T 1307-2016 history
2016YY/T 1307-2016 Medical digital X-ray image detector used in mammography