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IEC 62366 checklist Clause 条款 7 TRAINING AND MATERIALS FOR TRAINING/培训和培训材料 The required training on the MEDICAL DEVICE for safe User Manual and effective use of PRIMARY OPERATING FUNCTIONS by the intended USER is given by: 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： – necessary training materials provided by the manufacturer; 制造商提供的必要的培训材料； – necessary training materials are available; or 必要培训材料的可获得性； – the manufacturer provides TRAINING 或制造商提供培训 The ACCOMPANYING DOCUMENT describes the available training options (Recommendation: ACCOMPANYING DOCUMENT include the suggested duration and frequency of such training) 随机文件要描述可获得的培训选项 （推荐：随机文件包括此类培训时间和频度的建议） INTENDED USE AND USER PROFILE(S) are the basis for User Manual TRAINING and TRAINING material 预期用途和用户特征是培训和培训材料的基础。 Compliance User Manual User Manual User Manual Compliance Compliance User Manual Compliance Compliance Requirement 要求 Remark 解释 Verdict 判定 Compliance
EN62366 - 2008 医疗器械可用性工程评估报告
