During the clinical use of medical equipment，the performance indicators and safety of the equipment will change over time due to various reasons，directly affecting the quality of medical care and patient safetyTo ensure the quality and safety of medical care，the World Health Organization（WHO） has included medical equipment testing as one of the main components of equipment maintenance，falling under the category of Healthcare Technology Management（HTM）
Many domestic laws，regulations，standards and guidelines require necessary safety and performance testing for medical equipment in useIn 2021，the State Council issued the revised Regulations for the Supervision and Administration of Medical Device（State Council Order No739，2021），which stipulates that“medical device users should conduct regular inspections，tests，calibrations，maintenance，and necessary maintenance of medical devices in accordance with the requirements of the product instructions，and provide timely analysis and evaluation to ensure that the medical devices are in good condition，ensuring the quality of use”The Clinical Use Management Measures for Medical Devices（National Health Commission Order No8，2021） issued by the National Health Commission also states that“maintenance management of medical equipment should focus on testing and preventive maintenanceVerification of the appropriateness of medical device performance and its safety through performance testing and safety monitoring”The State Council Offices“Opinions on Strengthening the Performance Appraisal of Grade III Public Hospitals”（2019 State Office Document No4） specifically requires，under the thirdlevel indicators of medical quality“maintenance and quality control management of large medical equipment”，“necessary testing and quality control equipment must be provided for the maintenance and quality control of large medical equipment”In addition，the 2022“Management Measures for the Mutual Recognition of Medical Institutions Inspection and Testing Results”jointly issued by the National Health Commission，the National Medical Insurance Administration，the National Administration of Traditional Chinese Medicine，and the Health Bureau of the Logistics Support Department of the Central Military Commission，requires that“the instruments and equipment，reagents and consumables used for inspection and testing by medical institutions shall meet relevant requirements，and instruments and equipment shall be verified，inspected，calibrated，for stability measurements and maintenance as required”The“Metrology Law of the Peoples Republic of China”stipulates that measuring instruments included in the mandatory verification directory for trade settlement，safety protection，medical care，and environmental monitoring shall be subject to mandatory verificationMedical equipment included in the metrological equipment directory shall be regularly tested in accordance with the regulations
Currently，there are many standards related to the quality testing of medical equipment，mainly including national standards，national metrological verification regulation，healthcare industry standards，local standards，group standards，and enterprise standardsThe testing methods，standards，and requirements for different products and manufacturers of medical equipment are also differentThe scope of application of these standards and their relationships need to be correctly understood and clarified based on laws and regulations combined with practical work in hospitals
It is extremely important to carry out the quality testing of medical equipmentMedical quality testing of equipment has become a basic skill that clinical medical engineers in hospitals must master，and it is also a highly technical professional workWithout professional knowledge and training，it is difficult for clinical medical engineers to meet the requirements of practical workAt the same time，the development of medical equipment technology is fast，covering various medical specialties，including the development and application of digital integration and artificial intelligence medical equipmentAutomated and intelligent testing methods are also continuously developing，requiring constant updating of knowledge in the field of medical equipment quality testingCurrently，there are few professional books on this subject domestically and internationally，posing great difficulties for the comprehensive implementation of medical equipment quality testing workIn order to implement relevant laws and regulations，especially to implement“The Clinical Use Management Measures for Medical Devices”（National Health Commission Order No8，2021） issued by the National Health Commission，there is a need for a professional reference book on the technology of the quality testing of medical equipment to guide clinical medical engineers in carrying out the quality testing of medical equipment
To implement relevant laws and regulations and meet the needs of the development，National Institute of Hospital Administration of the National Health Commission organized the writing of the book Technical Guidelines for Use Quality Testing of Medical EquipmentThis book comprehensively explains the basic theory，knowledge，and skills of medical equipment quality testing，from the historical background and current situation，technical requirements，safety testing technology，imaging equipment，life support and emergency equipment，radiotherapy equipment，endoscopy equipment，disinfection and sterilisation equipment，artificial intelligence medical equipment，in vitro diagnostic equipment and laboratory equipmentAs an aid to illustration，the products of individual companies or certain manufacturers may appear in the illustrations in this book，but this does not imply that we endorse or recommend the products of those companies or manufacturersIn order to better demonstrate professionalism，practicality，and operability，the book was jointly written by clinical engineering experts who have long been engaged in the front line quality testing of medical equipment in medical institutions，medical equipment manufacturing companies，and professional personnel engaged in quality testing in thirdparty service organizationsThis book is suitable for personnel involved in the quality control of inuse medical equipment，such as hospital managers，clinical engineers in hospitals，quality management personnel in medical equipment companies，and quality testing technical personnel in thirdparty service organizationsIt is especially suitable as a reference for front line clinical medical engineering and technical personnel and managers in hospitals engaged in the quality control of inuse medical equipment
Due to time constraints in the writing of this book，shortcomings are inevitableIt would be much appreciated if you could provide any constructive criticism and/or feedbackDuring the writing process，some companies provided technical materials and other support，and we are especially grateful for their help
Ma LipingXie Songcheng
April，2024
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