This standard specifies the classification, requirements and test methods of medical diagnostic X-ray machines (hereinafter referred to as X-ray machines). This standard applies to medical diagnostic X-ray machines. For medical diagnostic X-ray machines that require national or industry-specific standards, the corresponding national or industry-specific standards should be implemented. This standard does not apply to X-ray computed tomography equipment.
YY/T 0106-2008 Referenced Document
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
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
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
GB 9706.14-1997 Medical electrical equipment--Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
GB 9706.15-1999 Medical electrical equipment Part 1: General requiements for safety 1.Collateral standard: Safety requirements for medical electrical systems
GB 9706.23-2005 Medical electrical equipment-Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures
GB 9706.24-2005 Medical electrical equipment-Part 2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices
GB 9706.3-2000 Medical electrical equipment-Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
GB/T 10149 Terminology and symbol for medical X-ray equipment
GB/T 19042.1-2003 Evaluation and routine testing in medical imaging departments--Part 3-1: Acceptance test--Imaging performance of X-ray equipment for radiographic and radioscopic systems
GB/T 19042.3-2005 Evaluation and routine testing in medical imaging departments-Part 3-3:Acceptance tests-Imaging performance of X-ray equipment for digital subtraction angiography(DSA)
YY 0076-1992 Coating classifications for metal product Technical conditions
YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY/T 0202 Specifications for medical diagnostic X-ray device for tomography*, 2009-06-16 Update
YY/T 0291-2007 Environmental requirements and test methods for medical X-ray equipment
YY/T 0106-2008 history
2021YY/T 0106-2021 General technical conditions for medical diagnostic X-ray machines
2008YY/T 0106-2008 General specifications for medical diagnostic X-ray equipment
2004YY/T 0106-2004 General specifications for medical diagnostic X-ray equipment