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CE-可用性工程评估报告(EN 62366)

上传者:科技星球 |  格式:doc  |  页数:11 |  大小:164KB

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ING/培训和培训材料РThe required training on the medical device for safe and effective use of primary operating functions by the intended User is given by: Р由预期用户安全有效使用医疗器械主要操作功能的必须培训包括:РUser ManualРComplianceР– necessary training materials provided by the manufacturer;Р制造商提供的必要的培训材料;РUser ManualРComplianceР– necessary training materials are available; orР必要培训材料的可获得性;РUser ManualРComplianceР– the manufacturer provides trainingР或制造商提供培训РUser ManualРComplianceРThe panying document describes the available training optionsР (mendation: panying document include the suggested duration and frequency of such training) Р随机文件要描述可获得的培训选项Р(推荐:随机文件包括此类培训时间和频度的建议)РUser ManualРComplianceРIntended use and user profile(s) are the basis for training and training materialР预期用途和用户特征是培训和培训材料的基础。РUser ManualРCompliance

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