FDA 510(K)软件评审要求.pptVIP

FDA 510(K)软件评审要求 Stephen Ling MEDLAB 什么是软件器械 “software devices,” including: firmware and other means for software-based control of medical devices stand-alone software applications software intended for installation in general-purpose computers dedicated hardware/software medical devices. accessories to medical devices when those accessories contain or are composed of software. 器械包含一个以上软件部件，零件或附件或包含独立的软件，叫做“软件器械”，包括以下内容： 固件以及其他医疗器械基础软件控制 单机软件应用 多用途计算机软件安装 专用硬件/软件医疗器械 附件或含附件医疗器械 Level of Concern 关注程度 Level of Concern refers to an estimate of the severity of injury that a device could permit or inflict, either directly or indirectly, on a patient or operator as a result of device failures, design flaws, or simply by virtue of employing the device for its intended use. Level of Concern is defined only for use Not related to device classification (Class I, II or III) or to hazard or risk analysis 关注程度参考由于器械的失效或设计瑕疵或简单因预期用途而使用器械带来的副作用而可能导致或引起的对病人或操作者伤害的严重性，无论直接或间接。 关注程度仅仅与预期用途有关 与器械的分类和危害以及风险分析无关 Level of Concern 关注程度 Major 严重的 Moderate 中等 Minor 轻微 Major Level of concern is Major if a failure or latent flaw could directly result in death or serious injury to the patient or operator. The level of concern is also Major if a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider. 如果失败或潜在的缺点可能是导致病人或操作者直接或间接的死亡或严重伤害，则关注程度是严重的。如果失败或潜在的缺点通过不正确或延迟的消息或护理者的行为可能导致病人或操作者间接的死亡或严重伤害，则我们认为关注程度也是严重的。 Moderate Level of concern is Moderate if a failure or latent design flaw could directly result in minor injury to the patient or operator. The level of concern is also Moderate if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. 如果失败或潜在的设计缺点可能轻微地伤害病人或操作者，则我们认为关注程度是中等的。如果失败或潜在的缺点通过不正确或延迟的消息或护理者的行为可能导致病人或操作者间接的轻微伤害，则我们认为关注程度也是重大的。