ABSTRACT
OBJECTIVE@#To improve the electromagnetic compatibility (EMC) quality of medical devices, improve the efficiency of EMC testing, and promote the speed of market approval.@*METHODS@#The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed, and the reasons of low EMC quality of medical devices were analyzed from the perspective of test.@*RESULTS@#Based on the analysis of the reasons, the suggestions were given from the perspectives of medical device manufacturers and testing organizations.@*CONCLUSIONS@#In order to ensure the quality of EMC of medical devices, medical device manufacturers, regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility, to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.
Subject(s)
Electromagnetic Phenomena , Industry , Electromagnetic FieldsABSTRACT
In the electromagnetic compatibility standards of active implantable medical devices such as ISO 14117,radiated immunity test above 450 MHz frequency is recommended to be carried out in the electromagnetic shielding room.However,different test locations and the shape/size of the shielding room may lead to very different electromagnetic field distribution in the radiation exposure area of the sample,thus affecting the consistency of the test.With the model built by COMSOL software,this paper analyzes the impact of different parameters,such as size of the room and position of torso simulator on the distribution of field intensity,and reaches results about the distribution of field intensity on the torso simulator area under tow sizes of shielding rooms and two typical test positions.The results show that the experimental consistency of the electric field intensity on the surface directly below the center of the antenna is not good enough,which may affect the repeatability of the test.
Subject(s)
Electromagnetic Fields , Prostheses and ImplantsABSTRACT
Based on analysis of the domestic and foreign laws and regulations for hearing aids,some suggestions of safety evaluation about standards,premarket technical review and regulation are presented in this article.It is hoped to be helpful for registration and regulation of hearing aids.
Subject(s)
Equipment Safety , Hearing AidsABSTRACT
This article elaborates electromagnetic compatibility of medical electrical equipment and the regulatory tests based on related standards. And elaborating the diversity and the necessity of rectification by specific cases and deeply discussing and summing up for improving the compatibility of medical electrical equipment.
Subject(s)
Electricity , Electromagnetic Fields , Equipment Failure , Equipment and SuppliesABSTRACT
In order to compare the radiation immunity test level of ISO 14708 series standards and the domestic and international environmental radiation standards and then to ascertain whether the radiated immunity test level has reached the limit of the radiation strength in the relevant radiation environmental standards, this paper calculated the radiation field intensity and power density according to the radiated immunity test of ISO 14708 standards, and compared with the limit of ICNIRP 1998 and GB 8702-2014.
Subject(s)
Electromagnetic Fields , Electromagnetic Radiation , Immunity , Prostheses and Implants , Radiation DosageABSTRACT
BACKGROUND: This work presents an experimental and modeling study of the electromagnetic environment in the vicinity of a high voltage substation located in eastern Algeria (Annaba city) specified with a very high population density. The effects of electromagnetic fields emanating from the coupled multi-lines high voltage power systems (MLHV) on the health of the workers and people living in proximity of substations has been analyzed. METHODS: Experimental Measurements for the Multi-lines power system proposed have been conducted in the free space under the high voltage lines. Field's intensities were measured using a referenced and calibrated electromagnetic field meter PMM8053B for the levels 0 m, 1 m, 1.5 m and 1.8 m witch present the sensitive's parts as organs and major functions (head, heart, pelvis and feet) of the human body. RESULTS: The measurement results were validated by numerical simulation using the finite element method and these results are compared with the limit values of the international standards. CONCLUSION: We project to set own national standards for exposure to electromagnetic fields, in order to achieve a regional database that will be at the disposal of partners concerned to ensure safety of people and mainly workers inside high voltage electrical substations.
Subject(s)
Humans , Algeria , Electromagnetic Fields , Heart , Human Body , Magnetic Fields , Magnets , Methods , Pelvis , Population DensityABSTRACT
As a rising automatic identification technology, radio frequency identification (RFID) is receiving considerable attention and eliciting widespread interest in medical institutions in China. Some medical institutions have begun exploring and developing RFID systems for kinds of applications. A majority of medical institutions pay insufficient attention to the issue of RFID interference with medical devices. Specialized standards for the application of RFID in healthcare environments are desired. And there are misalignments between existing technology standards. Further researches should be developed to study the influence on safety and efficiency of medical devices induced by RFID system.
ABSTRACT
To explore the electromagnetic compatibility in the shelter hospital system to adapt it to the future complex electromagnetic environment. The factors for electromagnetic interference were analyzed, and some measures were put forward including separating the interference source from the sensitive device, setting up shielding space, applying grounding measures, eliminating interference signals by filtering and etc. The electromagnetic compatibility in the shelter hospital system was detected through electromagnetic self-compatibility test and electromagnetic environ-mental suitability test for external radio frequency. Simulations and tests proved that the failures and mal-re-sponse due to electromagnetic interference were avoided in the shelter hospital system. The electromagnetic compatibility scheme can meet the requirements of emergency medical facilities for electromagnetic protection in field conditions.
ABSTRACT
With the enforcement of YY 0505-2012 standard,more attention has been paid to the electromagnetic compatibility test of medical electrical equipment.In all the test items involved in YY 0505-2012,the radiation emission test is the most complicated and the hardest to be passed,so it is very important to master the test method.Microwave therapy equipment is a kind of equipment using microwave radiation energy to treat diseases,and is supervised as class Ⅲ medical equipment.According to the requirements of the relevant standards,all the electromagnetic compatibility testing items of microwave equipment are listed,and the test difficulty and the test focus of the equipment are studied.In the frequency band of the radiation emission experiment,microwave treatment equipment is divided into different categories according to the purpose and environment of the application.By comparing the data of the tests,the differences of different classes of microwave treatment equipment in the radiation emission tests are summarized.
ABSTRACT
Objective:To master the methods of reducing electromagnetic interference by RFID system, and presents the feasible technical advices for hospital’s implementation to ensure the safety of applications of electronic medical devices. Methods:According to analysis the causes of electromagnetic interference by RFID system, the methods of suppressing the electromagnetic interference are put forward for practical application. Results:The clinical engineers could refer to the methods of suppressing the electromagnetic interference and then conduct and use the RFID system, taking account of the management efficiency and the safety of applications of the medical devices. Conclusion:To determine the proper strategy for RFID system application in medical management of hospital may reduce the electromagnetic interference to the electrical devices of hospital and ensure its safety of application.
ABSTRACT
A crescente inserção de tecnologia eletroeletrônica em estabelecimentos assistenciais de saúde (EAS), seja como equipamentos terapêuticos, de diagnóstico ou até mesmo suporte vital, tem sido vista pela comunidade científica como a grande responsável pelo aumento dos níveis de energia eletromagnética emitidos ao ambiente hospitalar. Dessa forma, quando a energia eletromagnética presente no ambiente atinge um determinado nível crítico, fica estabelecida uma situação que é propícia ao aparecimento de dois fenômenos indesejados: a interferência eletromagnética (EMI) em equipamentos médicos, e os riscos biológicos (RBL) em seres vivos. Um importante recurso para gerenciar a compatibilidade eletromagnética e evitar o aparecimento destes fenômenos é o conhecimento das características eletromagnéticas presentes nestes ambientes. O objetivo deste trabalho é diagnosticar o comportamento eletromagnético estabelecido em ambientes de grande concentração de fontes emissoras como, por exemplo, o encontrado em centros cirúrgicos, através de uma série de medições in situ das grandezas eletromagnéticas envolvidas nestes meios (campos elétricos, campos magnéticos, ruídos conduzidos). Com base nestas medidas é realizada uma avaliação crítica de modo a comparar a situação estabelecida nos EAS e os limites de segurança preconizados por organismos competentes, tanto para EMI quanto para RBL. Como resultado desta análise, começa a existir maior discernimento quanto à real situação do ambiente eletromagnético encontrado em EAS nacionais, subsidiando informações para a definição de diretrizes mais eficientes para implementação de programas de gestão tecnológica que são direcionados às necessidades específicas destes hospitais.
Advances in technology and the increased use of electro-medical equipment (EME) to support medical procedures such as monitoring, diagnosis, therapeutic or even life support are considered as greatly responsible for the increase of electromagnetic energy within health care facilities (HCF) environments. In such circumstances, when electromagnetic energy reaches a certain critical level, a dangerous situation is established and two undesirable phenomena can take place, both electromagnetic interference (EMI) in medical equipment, and biological risks (BLR) in living beings. The knowledge of electromagneticcharacteristics shown by these environments can represent an important tool in order to promote electromagnetic compatibility and avoid the appearance of undesirable phenomena. Therefore, this work aims to diagnose the electromagnetic profile established in critical areas, such as operating rooms, through a number of in situ measurements concerning electromagnetic quantities present in this environment (electric field, magnetic field, conducted noise). Moreover, a critical evaluation follows in order to compare the establishedsituation within HCF and the safety levels prescribed by regulatory organizations regarding EMI and BLR. As a result of this assessment, a better understanding on the actual situation concerning the electromagnetic environment in HCF can be achieved, allowing clinical engineers to define better directives in order to implement an adequate management programs in these hospitals.
Subject(s)
Electromagnetic Fields/adverse effects , Containment of Biohazards/methods , Containment of Biohazards/standards , Radiation Sources , Radiation Monitoring/statistics & numerical data , Radiation Monitoring/instrumentation , Radiation Monitoring/methods , Radiation Monitoring/standards , Equipment and Supplies, Hospital , Equipment and Supplies, Hospital/adverse effects , Equipment and Supplies, Hospital/standardsABSTRACT
Conducted electromagnetic interference (EMI) from a 7.5kVA DC/DC high power converter is investigated to agree with EN class A. Here in some passive methods of suppressing conducted EM Noise, such as mixed-mode (MM) EMI filters, snubbing circuits and other means, are used. Based on measurement, the sources of noise are detected with the characteristics analyzed in detail. The MM EMI filters is valuable means with which low-frequency part and some of the high frequency part of conducted EM Noise can be efficiently reduced. How to lay out the MM filters on both sides of the converter is outlined in detail. In addition, multiple grounding and RDC snubbing circuits are employed to improve the performance in high frequency. The experimental results confirm the methods adopted.
ABSTRACT
In view of China's medical equipment industry has not been equipped with a sound system and strict administration, it is wise to draw on FDA recommendations and seek effective ways of solving EMI problems. Further should focus on improving the performance of medical equipment so as to adapt to the different environment. In the end, the design of healthcare facilities to meet EMC standards is put forward specifically in four parts of electronic circuits, power circuits, display device, and the mechanical shell.