ku1314520 回复了问题 2023-09-17 22:31

医疗器械技术评审

问答 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. ...

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ku1314520 回复了问题 2023-09-17 22:30

医疗器械技术评审

问答 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 ...

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ku1314520 回复了问题 2023-09-17 22:27

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:26

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:24

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:23

医疗器械技术评审

问答 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 ...

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ku1314520 回复了问题 2023-09-17 22:22

医疗器械技术评审

问答 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 ...

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ku1314520 回复了问题 2023-09-17 22:20

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:19

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:17

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:16

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:15

医疗器械技术评审

问答 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...

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ku1314520 回复了问题 2023-09-17 22:13

医疗器械技术评审

问答 could the software information in the devicecertificate be updated during Registration Renewal?

ku1314520: Active medical devices and the cooperated softwareare independent medical devices, each with its own registrationcertificate, and the version of the c...

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ku1314520 回复了问题 2023-09-17 22:12

医疗器械技术评审

问答 If medical device software is updated, when willit need to submit Change of Permission Items?

ku1314520: First. manufacture should justify weather the update isconsidered as major update or minor update according to theGuidance for technical review of med...

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ku1314520 回复了问题 2023-09-17 22:11

医疗器械技术评审

问答 How to determine the naming rules for softwareversion?

ku1314520: The software version is used to identify the software statusand to control the software update. The naming rule of softwareversion is decided during t...

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