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 st...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 devices.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 18,2023.In the absence of a parameter description of the stimulators,a multimeter was used to measure the output voltage,resistance,and current.Thirty-two related devices for TEAS were obtained.The safety parameters ofmost devices were neither clearly defined,nor standardized,and in some cases weremissing.There was a noticeable disparity in the upper safety limits of the output current among the devices.The sizes of the skin electrode pads as well as the lengths of the electrode connecting wires of most devices were not clearly indicated.Acupoints 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 densities.It 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.展开更多
A medical device is an instrument that includes components,parts,or accessories to diagnose or treat patients.Since the complexity of medical devices has increased in recent years,functional safety and basic safety ar...A medical device is an instrument that includes components,parts,or accessories to diagnose or treat patients.Since the complexity of medical devices has increased in recent years,functional safety and basic safety are required to ensure the overall device safety.Functional 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 systems.This 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 function.The essential performance of E/E/PE systems is defined as the safety function of the functional safety.The target SIL of the essential performance is determined according to the potential risk levels,based on the classification rules of medical devices.This approach is applied to the pulse oximeter as a case study.The target SIL for the functionality of the power-failure alarm condition is determined to be SIL1.The target SILs of other functions are determined as SIL2.展开更多
基金supported by the National Key R&D Program of China(2022YFC3500501)Science and Technology Innovation Project(CI2023C017YL)of China Academy of Chinese Medical Sciences2021 Qihuang Scholar Support Project(Peijing Rong).
文摘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 devices.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 18,2023.In the absence of a parameter description of the stimulators,a multimeter was used to measure the output voltage,resistance,and current.Thirty-two related devices for TEAS were obtained.The safety parameters ofmost devices were neither clearly defined,nor standardized,and in some cases weremissing.There was a noticeable disparity in the upper safety limits of the output current among the devices.The sizes of the skin electrode pads as well as the lengths of the electrode connecting wires of most devices were not clearly indicated.Acupoints 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 densities.It 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.
文摘A medical device is an instrument that includes components,parts,or accessories to diagnose or treat patients.Since the complexity of medical devices has increased in recent years,functional safety and basic safety are required to ensure the overall device safety.Functional 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 systems.This 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 function.The essential performance of E/E/PE systems is defined as the safety function of the functional safety.The target SIL of the essential performance is determined according to the potential risk levels,based on the classification rules of medical devices.This approach is applied to the pulse oximeter as a case study.The target SIL for the functionality of the power-failure alarm condition is determined to be SIL1.The target SILs of other functions are determined as SIL2.
