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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

ku1314520 在 2023-09-17 22:17 回答了问题 医疗器械技术评审: is it not applicable to the cybersecurityrequirement?; ku1314520: The applicability of cybersecurity for medical device refersto not only the network connection for electronic data transfer andremote control, but als...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:16 回答了问题 医疗器械技术评审: Can the cybersecurity descriptiondocument be submitted within the software descriptiondocument?; ku1314520: The“Guidance for premarket review for medical devicescybersecurity”is applicable to the registration and applicationof Class I and Class Il medical de...; 赞同0 反对 0 人感谢 0 评论 1 回复

ku1314520 在 2023-09-17 22:15 回答了问题 医疗器械技术评审: If the Android APP is registered, isit necessary to be tested when adding iOS APP?; ku1314520: Android and iOS are incompatible operating systemplatforms. To add iOS Apps across platforms, it is necessary to betested with the host, and submit th...; 赞同0 反对 0 人感谢 0 评论 1 回复

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