ce-可用性工程評(píng)估報(bào)告en62366(參考版)
2025-05-16 18:20本頁面
【正文】 User ManualCompliance。制造商提供的必要的培訓(xùn)材料；User ManualCompliance– necessary training materials are available。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 ManualComplianceThe Acpanying document is written at a level consistent with the intended operator profile隨機(jī)文件的編寫要與用戶特征的水平相一致。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)。 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)療收益是否超過可用性問題帶來的風(fēng)險(xiǎn)。Products do not have this requirementnonplianceThe results are recorded in the usability engineering 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 requirementnonplianceThe results of the verification are recorded in usability engineering file驗(yàn)證的結(jié)果應(yīng)記錄于可用性工程文檔。User ManualComplianceUser interface design and implementation/用戶界面設(shè)計(jì)和實(shí)施Manufacturer designed and implemented the user interface as described in the usability Specification utilizing, as appropriate, usability engineering methods and techniques制造商應(yīng)使用可用性工程的方法和技術(shù)來開發(fā)并實(shí)施可用性規(guī)范描述的用戶界面。 and基于可用性規(guī)范，對(duì)主要操作功能可用性的確認(rèn)標(biāo)準(zhǔn)User ManualCompliance– the involvement of representative intended users 包含的預(yù)期用戶代表User ManualComplianceusability validation performed in a laboratory setting :可用性確認(rèn)實(shí)施的實(shí)驗(yàn)室設(shè)置：Test report.Complianceusability validation performed in a simulated use environment :可用性確認(rèn)實(shí)施于模擬使用環(huán)境：Test reportComplianceusability validation performed in the actual use environment :可用性確認(rèn)實(shí)施于真實(shí)使用環(huán)境：Test reportComplianceThe usability validation plan addresses: 可用性確認(rèn)計(jì)劃包括：– frequent Use Scenarios, and常見的使用情景；– reasonably foreseeable worst case use scenarios合理可預(yù)見的最壞使用情景that are identified in the usability specification都要在可用性規(guī)范中識(shí)別。主要操作功能對(duì)于用戶界面的要求，包括降低風(fēng)險(xiǎn)的那些；Risk analysis report Compliance– Requirements for determining whether primary operating functions are easily recognizable by the User.用于決定主要操作功能是否易于被用戶認(rèn)知的要求Risk analysis report ComplianceUsability validation plan/可用性確認(rèn)計(jì)劃The manufacturer has developed and maintains a
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