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Science of Traditional Chinese Medicine 2024年第2期2卷 71-81页

作者： Lei Wang Xinjiang Zhang Bowen Feng Shuai Zhang Yanfeng Zheng Chen Xin Chong Su Fang Wang Mozheng Wu Jinling Zhang Yuqi Liu Liang Li Chris Zaslawski Peijing Rong Institute of Acupuncture and Moxibustion China Academy of Chinese Medical SciencesBeijingChina Department of Geriatrics Dongzhimen HospitalBeijing University of Chinese MedicineBeijingChina School of Information Science and Technology Beijing University of Chemical TechnologyBeijingChina Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesBeijingChina School of Life Sciences Faculty of ScienceUniversity of Technology SydneySydneyAustralia

A review was undertaken of the operation process and development of transcutaneous electrical acupoint stimulation(TEAS)and related devices for TEAS,with the aim to offer a reference for developing an international standard for the basic safety and essential performance of the *** articles related to TEAS and instruction of devices for TEAS were searched using the EMBASE,MEDLINE,and Web of Science databases with the time period from inception to July 18,*** the absence of a parameter description of the stimulators,a multimeter was used to measure the output voltage,resistance,and ***-two related devices for TEAS were *** safety parameters ofmost devices were neither clearly defined,nor standardized,and in some cases *** was a noticeable disparity in the upper safety limits of the output current among the *** sizes of the skin electrode pads as well as the lengths of the electrode connecting wires of most devices were not clearly *** on different parts of the human body,including the upper limbs,head,auricle,chest,abdomen,trunk,and lower limbs,required different maximum tolerable current intensities and current *** is important to indicate comprehensive output/safety parameters and essential performance for devices for TEAS to meet the need of global distribution,achieve precise stimulation parameters at different acupoints across the human body,and allay any safety concern of national therapeutic device authorities,the regulators,manufacturers,and end users.

关键词： Transcutaneous electrical acupoint stimulation Acupoint Device for transcutaneous electrical acupoint stimulation Basic safety essential performance

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保障医疗设备硬件系统功能安全的有效方法(英文)

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中国医疗设备 2015年第12期30卷 27-33,15页

作者： KIM Gi-young WANG Da-wei PARK Ho-joon JANG Joong-soon Department of Industrial Engineering Ajou University Medical Device Evaluation Engineering Center Korea Testing Laboratory

A medical device is an instrument that includes components,parts,or accessories to diagnose or treat *** the complexity of medical devices has increased in recent years,functional safety and basic safety are required to ensure the overall device *** safety is part of the overall safety that relates to the equipment under control(EUC)and to the EUC control system that depends on the correct functionality of the electrical/electronic/programmable electronic(E/E/PE)safety-related *** study proposes approach methods to functional safety of medical devices for which it is important to correctly identify the safety functions and the safety integrity level(SIL).The relationship between the functional safety and essential performance is identified focusing on the safety *** essential performance of E/E/PE systems is defined as the safety function of the functional *** target SIL of the essential performance is determined according to the potential risk levels,based on the classification rules of medical *** approach is applied to the pulse oximeter as a case *** target SIL for the functionality of the power-failure alarm condition is determined to be *** target SILs of other functions are determined as SIL2.

关键词： functional safety medical device essential performance classification rule safety function pulse oximeter

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