ce-可用性工程評估報告en62366-資料下載頁
2025-05-13 18:20本頁面
【正文】 neering file確認的結果應記錄于可用性工程文檔。Products do not have this requirementnonplianceFor the acceptance criteria documented in the usability validation plan that are not met:對于沒有可用性確認計劃中制定的未被滿足的接收準則： further User Interface design and implementation activities are performed。 or需要進行進一步的用戶界面設計和執(zhí)行；或 if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determine if the medical benefits of the INTENDED USE outweigh the RISK arising from USABILITY problems如果進一步的改進不現(xiàn)實，制造商需要收集并評審數據和文獻，以確定預期用途的醫(yī)療收益是否超過可用性問題帶來的風險。To perform this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.為此，制造商需評估可用性問題帶來的風險。Products do not have this requirementnonpliance6ACCOMPANYING DOCUMENTS/隨機文件The Acpanying document includes a summary of the Medical Device application specification隨機文件應包括醫(yī)療器械應用的規(guī)格的總結。User ManualComplianceA concise description of the Medical Device, its operating principles, significant physical and performance characteristics and intended User Profile are included in the Acpanying document隨機文件包括醫(yī)療器械、工作原理、重要的物理和性能特性和預期用戶的特征的簡要描述。User ManualComplianceThe Acpanying document is written at a level consistent with the intended operator profile隨機文件的編寫要與用戶特征的水平相一致。User ManualComplianceThe Acpanying document for equipment are, optionally, provided electronically設備的隨機文件或者可以電子文件提供。User ManualComplianceUsability engineering process includes the information that will need to be provided as a hard copy or as markings on Medical Device when acpanying documents are provided electronically當隨機文件是電子形式時，可用性工程過程應包括在醫(yī)療器械上需要以硬拷貝或標識提供的信息。User ManualCompliance 7TRAINING AND MATERIALS FOR TRAINING/培訓和培訓材料The required training on the medical device for safe and effective use of primary operating functions by the intended User is given by: 由預期用戶安全有效使用醫(yī)療器械主要操作功能的必須培訓包括：User ManualCompliance– necessary training materials provided by the manufacturer。制造商提供的必要的培訓材料；User ManualCompliance– necessary training materials are available。 or必要培訓材料的可獲得性；User ManualCompliance– the manufacturer provides training或制造商提供培訓User ManualComplianceThe Acpanying document describes the available training options (Remendation: acpanying document include the suggested duration and frequency of such training) 隨機文件要描述可獲得的培訓選項（推薦：隨機文件包括此類培訓時間和頻度的建議）User ManualComplianceIntended use and user profile(s) are the basis for training and training material預期用途和用戶特征是培訓和培訓材料的基礎。User ManualCompliance
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