EN 60601-1-6Medical electrical equipmentPart 1-6: General requirements for safety - Collateral Standard: UsabilityEN 62366Medical devicesApplication of usability engineering to medical devicesReport Reference No......................:Compiled by (+ signature)...............:Approved by (+ signature)...............:Date of issue...................................:Company name...............................:Address..........................................:Test specification:Standard.........................................:EN 60601-1-6:, EN 62366:Test item description.......................:Trade Mark.....................................:Manufacturer...................................:Model/Type reference.....................:Ratings...........................................: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)Test Result..............................................................: PassedEN 60601-1-6ClauseRequirement + TestResult - RemarkVerdict4General requirements总规定4.1Conditions for application to ME EQUIPMENTME设备应用条件The ME EQUIPMENT shall provide adequate USABILITY such that the RISKS resulting from NORMAL USE and USE ERROR are acceptable. See also 7.1.1 and 12.2 of the general standard.ME设备应提供充足的可用性，使得由于正常使用和使用错误造成的风险是能够接受的。参见通用原则的7.1.1和12.2。4.2USABILITY ENGINEERING PROCESS for ME EQUIPMENTME设备的可用性工程程序A USABILITY ENGINEERING PROCESS complying with IEC 62366 shall be performed.可用性工程程序按照IEC 62366执行。— established a USABILITY ENGINEERING PROCESS;建立一种可用性工程程序;— established acceptance criteria for USABILITY; and建立可用性验收原则;和demonstrated tha...
