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ku1314520 在 2023-09-17 22:32 回答了问题 医疗器械技术评审: Medical endoscopes have several models, how tochoose the typical model for type test?; ku1314520: Generally, the following factors should be taken into accountin the selection of typical endoscopes in one registration unit:For endoscopes with diffe...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:31 回答了问题 医疗器械技术评审: Do medical optical endoscope and laser fiberoptics need to be tested for EMC?; ku1314520: Both medical optical endoscope and laser fiber opticsbelongs to the applied part of medical electric equipment. They don'have main supply connection. ...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:30 回答了问题 医疗器械技术评审: Do wireless accessories of the active medicaldevices need to be tested during the EMC test?; ku1314520: Whether the active medical device accessories need to betested for EMC has nothing to do with the connection form of theproduct, which mainly depends ...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:27 回答了问题 医疗器械技术评审: How to choose the operation mode in EMC test?; ku1314520: The maximum emission operating mode shall be identifiedThe operation mode shall comprehensively and detailedly identifythe “function”described i...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:26 回答了问题 医疗器械技术评审: How to determine the essential performance ofimmunity test in EMC test of active medical devices?; ku1314520: “Essential performance’ refers to the achievement ofperformance of a clinical function, other than that related to BASICSAFETY, where loss or degradat...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:24 回答了问题 医疗器械技术评审: Is it necessary for EMC test together withinactive accessories in product composition?; ku1314520: In general, equipment and devices used in EMC test, cablelayout and accessories in typical configuration shall be consistentwith those in normal...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:23 回答了问题 医疗器械技术评审: How to select EMC test samples?; ku1314520: If there are multiple models and accessories in theapplication registration unit of active medical devices, theadministrative counterparts shall take ...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:22 回答了问题 医疗器械技术评审: Is it necessary to associate EMC test report withelectrical safety test report?; ku1314520: During product registration and changing registration, EMCtest report and electrical safety test report shall be related to ensurethat the electrical ...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:20 回答了问题 医疗器械技术评审: the sproduct mode andspecification and instruction for division%?; ku1314520: According to“Guidance for Product Technical Requirementof medical device”, the product model and/or specifications shallbe clearly defined in the Prod...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:19 回答了问题 医疗器械技术评审: how to describe the computer in the productregistration?; ku1314520: If the active medical device is used with a general-purposecomputer, the computer may not be an composition components ofthe product, but the requirem...; 赞同0 反对 0 人感谢 0 评论 1 回复

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