ce-可用性工程評(píng)估報(bào)告en62366-資料下載頁(yè)
2025-05-13 18:20本頁(yè)面
【正文】 neering file確認(rèn)的結(jié)果應(yīng)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(duì)于沒(méi)有可用性確認(rèn)計(jì)劃中制定的未被滿足的接收準(zhǔn)則： further User Interface design and implementation activities are performed。 or需要進(jìn)行進(jìn)一步的用戶界面設(shè)計(jì)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(jìn)一步的改進(jìn)不現(xiàn)實(shí)，制造商需要收集并評(píng)審數(shù)據(jù)和文獻(xiàn)，以確定預(yù)期用途的醫(yī)療收益是否超過(guò)可用性問(wèn)題帶來(lái)的風(fēng)險(xiǎn)。To perform this step, the MANUFACTURER needs to estimate the RISK arising from USABILITY problems.為此，制造商需評(píng)估可用性問(wèn)題帶來(lái)的風(fēng)險(xiǎn)。Products do not have this requirementnonpliance6ACCOMPANYING DOCUMENTS/隨機(jī)文件The Acpanying document includes a summary of the Medical Device application specification隨機(jī)文件應(yīng)包括醫(yī)療器械應(yīng)用的規(guī)格的總結(jié)。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(jī)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(yù)期用戶的特征的簡(jiǎn)要描述。User ManualComplianceThe Acpanying document is written at a level consistent with the intended operator profile隨機(jī)文件的編寫(xiě)要與用戶特征的水平相一致。User ManualComplianceThe Acpanying document for equipment are, optionally, provided electronically設(shè)備的隨機(jī)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(dāng)隨機(jī)文件是電子形式時(shí)，可用性工程過(guò)程應(yīng)包括在醫(yī)療器械上需要以硬拷貝或標(biāo)識(shí)提供的信息。User ManualCompliance 7TRAINING AND MATERIALS FOR TRAINING/培訓(xùn)和培訓(xùn)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(yù)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(xùn)包括：User ManualCompliance– necessary training materials provided by the manufacturer。制造商提供的必要的培訓(xùn)材料；User ManualCompliance– necessary training materials are available。 or必要培訓(xùn)材料的可獲得性；User ManualCompliance– the manufacturer provides training或制造商提供培訓(xùn)User ManualComplianceThe Acpanying document describes the available training options (Remendation: acpanying document include the suggested duration and frequency of such training) 隨機(jī)文件要描述可獲得的培訓(xùn)選項(xiàng)（推薦：隨機(jī)文件包括此類(lèi)培訓(xùn)時(shí)間和頻度的建議）User ManualComplianceIntended use and user profile(s) are the basis for training and training material預(yù)期用途和用戶特征是培訓(xùn)和培訓(xùn)材料的基礎(chǔ)。User ManualCompliance
環(huán)評(píng)公示相關(guān)推薦
鄂ICP備17016276號(hào)-1