18Usability engineering is applied to the medical device reporting可用性工程学应用.pdf

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Usability engineering is applied to the medical device
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可用性工程学应用
R eport R eference No........................... C E09-EN62366A
Date of issue.......................................... :
Total number of pages........................... 8
Abbreviations used in the report:
-Usability Engineering: UE -Risk analysis: RA
-User interface: UI -Risk management: RM
-Primary operating function: POF
Possible test case verdicts:
-test case does not apply to the test object.......................... : N/A
-test object does meet the requirement................................ : Pass (P)
-test object does not meet the requirement.......................... : Fail (F)
C OMPANY NAME:
C ompany Address:
Product:
Accessories:
Procedure:
Result: 公司的产品依据标准进行自我评定，符合EN 62366的要求。
编制 C ompiled by:
(Name/Title/Dept.) 日期Date: ___________________________
审核 Reviewed by
(N ame/Title/Dept.) 日期Date: ___________________________
批准 Approved b