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To study the basic safety and basic performance of medical electrical equipment,to form quality control in multiple aspects of design,research and development,verification,circulation,application and maintenance,and to promote effective supervision of medical equipment safety.The differences between national standards GB9706.1-2007 and GB9706.1-2020 were compared and analyzed,and the product safety and requirements were updated by combining product design documents,usability documents and risk management documents.A full life cycle quality control process for medical electrical equipment was proposed to improve the demonstration of compliance under the new standard.Manufacturers should strengthen the risk management strategies,clarify the awareness of quality responsibility,establish the full life cycle quality control methods for medical electrical equipment,and meet the requirements for product registration and post-market supervision.
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The background and scope of the revision of GB 9706.255-2022"Medical Electrical Equipment-Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors"were introduced.The differences between GB 9706.255-2022 and YY 0601-2009"Medical electrical equipment particular requirements for basic safety and essential performance of respiratory gas monitors"were summarized.The key points of the revision of GB 9706.255-2022 were interpreted in terms of basic performance,marking signs and documents,protection level,calibration/nulling,rough handling,functional connectivity and usability.References were provided for manufacturers and inspection technicians to correctly understand GB 9706.255-2022.[Chinese Medical Equipment Journal,2023,44(11):79-82]
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This study mainly discusses the contents, methods and characteristics of the collection of operation and maintenance data, as well as the establishment and evaluation methods of the distribution model of the failure time of medical electrical equipment. The distribution models of failure time at three levels of medical electrical equipment are established by linear regression method and goodness of fit test:The first is the device level MTBF distribution model, the second is the failure rate distribution model of the failure mode of key components, the third is the calculation model of the influence coefficient of influence factor on the failure mode of key components. This study presents a method of establishing MTBF segment model and implements a calculation model of influence coefficient varying with time.
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ManutençãoRESUMO
The reliability of domestic medical equipment is one of the main factors that restrict the competitiveness of domestic medical devices. It is also an important factor that endangers the safety of patients and a blind spot in safety risk management. By analyzing the core elements of reliability and the situation of domestic medical device industry, this paper sorts out and analyzes the problems existing in the reliability of medical device industry, and puts forward the key points and problems to be solved to improve the reliability of domestic medical equipment products.
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Humanos , Desenho de Equipamento , Segurança de Equipamentos , Equipamentos e Provisões , Indústrias , Reprodutibilidade dos Testes , Gestão de Riscos , Gestão da SegurançaRESUMO
From the perspective of the organizers of medical electrical EMC laboratory, this paper elaborates the guiding principles, design ideas and experience of building medical EMC Laboratory. According to the needs of the laboratory, the basic requirements of anechoic chamber, the auxiliary room of anechoic chamber and other supporting rooms in the EMC laboratory are introduced. The key technologies of anechoic chamber, such as frequency range, shielding requirement and static zone, are mainly elaborated, so as to build a laboratory matching with test requirement.
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Humanos , Laboratórios , TecnologiaRESUMO
Objective To study the requirements for defibrillation protection testing and marking of the multi-parameter monitor to facilitate the manufacturer to understand related standards and design products rationally.Methods The background and principle were described for defibrillation protection testing of the monitor.The requirements of related standards were analyzed for defibrillation protection testing and marking,and the defibrillation protection flow was explored during the clinical application of the monitor.Results The multi-parameter monitor might be damaged in case of the monitor's deficiencies in the the defibrillation protection,even patient's failure in the defibrillation protection or death might occur,and the electrical shock could be caused also to medical staffs.Conclusion The defibrillation protection is of great significance for the multi-parameter monitor,and considerations have to be posed on standards requirements and the monitor's clinical application so as to decrease its use risks.
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Objective To study the protective earth requirement for touched metal parts of medical electrical equipment to improve the manufacturer's understanding on national standards.Methods The isolation methods for the touched metal parts in national standards were studied,and the principle of protective earth combined with insulation separating was analyzed.The characteristics of the second isolation method was discussed,and the respiratory system structure and electroshock protection of the anaesthetic machine were taken as examples.Results The touched metal parts with no measures for grounding,double isolation or reinforced insulation was determined by structure detection to meet the requirements of national standards in case basic insulation ceased to be effective and the parts were uncharged.Conclusion The necessities to girt the touched metal parts with measures for grounding,double isolation or reinforced insulation should depend on the understanding on national standards and electrical construction of the equipment under test by structure detection.
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Objective:To enhance the functional safety of medical electrical equipment and reduce the risk to patient when using the medical electrical equipment.Methods: Theory and rationale introduction of functional safety and provide application cases.Results: Introduce the definition and application scope of functional safety standards IEC 61508, the determination of safety integrity level of functional safety in the Medical Electrical equipment, and the design structure and development, meanwhile show some application examples.Conclusion: Provide suggestions for the manufactures for safety design that introduce functional safety standards IEC 61508 to the development process of Medical Electrical equipment will help enhance the safety level of Medical Electrical equipment and reduce the unacceptable risk’s probability to patient.
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According to the Common Specification of Medical Electrical Equipment with GB 9706.1—2007 and the Environment Requirements and Testing Ways of Medical Electrical Equipment with GB/T 14710—1993,the solving methods in the electrical examination are put forward. Application of the practical method of operation,reasonable and effective protective measures to address the medical electrical equipment for general safety requirements and the environmental requirements test and the actual operation encountered some problems. The medical electrical equipment has been designed and tested in scientific and accurate electrical testing,electric shock protection,environmental testing,and the results of the operation specification.