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似水流年在 2023-09-17 22:38 发起了提问 医疗器械技术评审: 问答 predicate medical device in clinicalevaluation?

ku1314520: Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluati...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:37 发起了提问 医疗器械技术评审: 问答 can we onlycompare the key performances?

ku1314520: Comparison with predicate medical device in clinicalevaluation for active medical device, what content to be comparedis relevant to the product featur...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:36 发起了提问 医疗器械技术评审: 问答 Under what circumstances do environmentatests need to be carried out on medical electricalequipment?

ku1314520: If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if ...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:35 发起了提问 医疗器械技术评审: 问答 When submit Change of Permission Items foradding models, is it necessary for type testing?

ku1314520: First, it is necessary to identify whether the adding modelscan be regarded as the same registration unit with the originalmodels. If so, application ...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:33 发起了提问 医疗器械技术评审: 问答 can theelectrical safety and electromagnetic compatibility test beexempted?

ku1314520: The change of the shell structure and the overall sealingperformance of the equipment may lead to the change of theelectrical safety and electromagnet...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:31 发起了提问 医疗器械技术评审: 问答 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...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:30 发起了提问 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. ...; 关注问题 1  0  0 评论

似水流年在 2023-09-17 22:29 发起了提问 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 ...; 关注问题 1  0  0 评论

似水流年在 2023-09-13 12:56 发起了提问 验证确认 灭菌: 问答灭菌工艺验证如何明确生物指示剂D值？

xbs999: 在灭菌工艺验证中，同时进行热分布（穿透）试验和微生物挑战试验，其目的在于评价物理杀灭时间 FPHY和生物杀灭时间 FBIO的一致性。对于一个灭菌程序而言，当一个生物指示剂的生物杀灭时间可测量时，在同一位置测得的物理杀灭时间和生物杀灭时间应该是相等的。本品采取过度杀灭工艺（121℃...; 关注问题 1  0  0 评论

似水流年在 2023-09-13 12:46 发起了提问 验证确认 灭菌: 问答为什么要在灭菌工艺验证时要加入微生物挑战试验呢？合理D值及含足够孢子量又是指什么？

xbs999: 国内《化学药品注射剂灭菌和无菌工艺研究及验证指导原则（试行）》中是这样描述的：“湿热灭菌工艺的微生物挑战试验是指将一定量已知 DT值的耐热芽孢（生物指示剂）在设定的湿热灭菌条件下进行灭菌，以验证设定的灭菌工艺是否确实能使产品达到预定的无菌保证水平。生物指示剂被杀灭的程度，是评价一个灭菌程序有效性的直...; 关注问题 1  0  0 评论

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