中英文 可用性评价报告 评价标准_图文.docVIP

产品名称: 可用性评价报告 文件编号： 编 制： 采用标准：EN?606011-6:2010, EN 62366:2008 审 核： Page PAGE 3 of NUMPAGES 10 EN 60601-1- Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability EN 62366 Medical devices Application of usability engineering to medical devices Report Reference No. : Compiled by (+ signature) : Approved by (+ signature) : Date of issue : Company name : Address : Test specification: Standard : EN?606011-6:2010, EN 62366:2008 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 : Passed 产品名称: 可用性评价报告 文件编号：JKH- 编 制： 采用标准：EN?606011-6:2010, EN 62366:2008 审 核： EN?60601-1-6 Clause Requirement + Test Result - Remark Verdict 4 General requirements 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 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 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; 建立一个可用性工程程序; — established acceptance criteria for USABILITY; and 建立可用性验收标准;和 demonstrated that the acceptance criteria for USABILITY have been 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 replacements shall apply: Replace the first two paragraphs including 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 EQU