中英文可用性评价报告评价标准.docxVIP

产品名称： 可用性评价报告 文件编号： 编制： 采用标准：EN 60601-1-6:2010, EN 62366:2008 审核： EN 60601-1-6 Medical electrical equipme nt Part 1-6: General requirements for safety - Collateral Standard: Usability EN 62366 Medical devices Application of usability engineering to medical devices Report Referenee No Compiled by (+ sig nature) Approved by (+ sig nature) Date of issue Compa ny n ame Address Test specificati on: Sta ndard : EN 60601-1-6:2010, EN 62366:2008 Test item descripti on Trade Mark Manufacturer Model/Type refere nee 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 : Passed 产品名称： 可用性评价报告 文件编号：JKH- 编制： 采用标准：EN 60601-1-6:2010, EN 62366:2008 审核： EN 60601-1-6 Clause Requireme nt + Test Result - Remark Verdict 4 Gen eral requireme nts 总要求 4.1 Conditions for application to ME EQUIPMENT ME设备应用条件 The ME EQUIPMENT shall provide adequate USABILITY such that the RISKS resulti ng from NORMAL USE and USE ERROR are acceptable. See also 7.1.1 and 12.2 of the gen eral sta ndard. ME设备应提供充分的可用性，使得由于正常使用和使用错 误导致的风险是可以接受的。参见通用标准的 7.1.1和12.2。 4.2 USABILITY ENGINEERING PROCESS for ME EQUIPMENT ME设备的可用性工程程序 A USABILITY ENGINEERING PROCESS complyi ng with IEC 62366 shall be performed. 可用性工程程序按照IEC 62366执行。 —established a USABILITY ENGINEERING PROCESS; 建立一个可用性工程程序 ； ——established accepta nee criteria for USABILITY; and 建立可用性验收标准；和 dem on strated that the accepta nee criteria for USABILITY have bee n met. 证明可用性已达到验收标准。 4.3 REPLACEMENT OF REQUIREMENTS GIVEN IN IEC 62366 IEC 62366中的代替要求 In addition to requirements of IEC 62366 the following replaceme nts shall apply: Replace the first two paragraphs in clud ing NOTES 1 and 2 of Clause 6 of IEC 62366:2007 by: 适用IEC 62366除了以下的要求更换： 将IEC 62366:2007第6条款的前两段包括备注 1和2用以 下内容替换。 The instructions for use shall include a brief description of the ME EQUIPMENT, its physical operati ng pri