中英文可用性评价报告评价标准.doc
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1、产品名称: 可用性评价报告文件编号:编 制:采用标准:EN606011-6:2010, EN 62366:2008审 核: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):
2、Approved by (+ signature):Date of issue:Company name:Address:Test specification:Standard:EN606011-6:2010, EN 62366:2008Test 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 r
3、equirement:Pass (P)- test object does not meet the requirement:Fail (F)Test Result:Passed Page 10 of 10产品名称: 可用性评价报告文件编号:JKH-编 制:采用标准:EN606011-6:2010, EN 62366:2008审 核:EN60601-1-6ClauseRequirement + TestResult - RemarkVerdict4General requirements总要求4.1Conditions for application to ME EQUIPMENTME设备应用
4、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。4.2USABILITY ENGINEERING PROCESS for ME EQUIPMENTME设备的可用性工程程序A USAB
5、ILITY 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。4.3REPL
6、ACEMENT OF REQUIREMENTS GIVEN IN IEC 62366IEC 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 instructio
7、ns for use shall include a brief description of the ME EQUIPMENT, its physical operating principles and significant physical and performance characteristics relevant to its USABILITY. The same information shall also be included in the technical description, if this is provided as a separate document
8、.设备的简要描述,运行原理、与可用性相关的重要物理特性和性能应包含在使用说明书中。如果技术说明书单独提供,则相同的信息也应包含在技术说明书中。The instructions for use shall contain a summary of the application specification.使用说明应包含一个应用规范的总结。EN62366ClauseRequirement + TestResult - RemarkVerdict4GENERAL REQUIREMENTS总要求4.1General Requirements总要求4.1.1Usability Engineering
9、Process可用性工程过程The MANUFACTURER shall establish document and maintain a USABILITY ENGINEERING PROCESS to provide SAFETY for the PATIENT, USER and others related to USABILITY. The PROCESS shall address USER interactions with the MEDICAL DEVICE according to the ACCOMPANYING DOCUMENT, including, but not
10、 limited to:- transport;- storage;- installation;- operation;- maintenance and repair; and- disposal.制造商应建立、形成文件和保持可用性工程过程,以便为患者、用户和其他与可用性有关的人员提供安全性。该过程应按照随附文件描述用户和医疗器械的交互,随附文件包括(但不限于) :运输;储存;安装;操作;维护和维修;处置。4.1.2Residual risk 剩余风险If the USABILITY ENGINEERING PROCESS detailed in this International St
11、andard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then, for the purposes of ISO 14971, the RESIDUAL RISKS associated with USABILITY of the MEDICAL DEVICE shall be presumed to be acceptable, unless there is OBJECTIVE EVIDENC
12、E to the contrary.如果遵守了本标准中详细规定的可用性工程过程和满足了可用性确认计划中形成文件的可接受准则(见5.9),则对ISO14971来说,与医疗器械的可用性有关的剩余风险应认为是可接受的,除非有相反的客观证据。4.1.3Information for Safety安全性信息If information for SAFETY is used as a RISK CONTROL measure, the MANUFACTURER shall subject this information to the USABILITY ENGINEERING PROCESS.如果安全性
13、信息用作风险控制措施,制造商应将此信息纳入可用性工程过程。4.2Usability Engineering File可用性工程文挡The results of the USABILITY ENGINEERING PROCESS shall be recorded in the USABILITY ENGINEERING FILE. The RECORDS and other documents that form the USABILITY ENGINEERING FILE may form part of other documents and files.可用性工程过程的结果应记录在可用性
14、工程文档中。构成可用性工程文挡的记录和其他文档可以是其他文件和文档的一部分。4.3Scaling of the Usability Engineering effort可用性工程工作范围界定The USABILITY ENGINEERING PROCESS may vary in form and extent based on the nature of the MEDICAL DEVICE, its intended USER and its INTENDED USE (see D.3.2). In the case of the modification of a MEDICAL DEV
15、ICE design, the USABILITY ENGINEERING PROCESS may be scaledup or scaled-down based on the significance of the modification as determined by the results of the RISK ANALYSIS (see D.3.2.2).可用性工程过程的形式和程度可根据医疗器械种类、其预期用户和预期用途(见D3.2) 的不同。对医疗器械的设计更改,可用性工程过程可以根据风险分析结果(见D3.2.2) 所确定的更改的重要性而扩大或缩小工作范围。5USABILTY
16、 ENGINEERING PROCESS可用性工程过程5.1Application specification 应用规范The MANUFACTURER shall specify the application of the MEDICAL DEVICE in the USABILITY ENGINEERING FILE.制造商应在可用性工程文档中规定医疗器械的应用。This specification shall include: * intended medical indication; intended PATIENT population; intended part of the
17、 body or type of tissue applied to or interacted with; * intended USER PROFILE; * intended conditions of use; and * operating principle.此规范应包括:*预期的医疗适应症;所应用的或与之交互的预期的身体部分或组织类型;*预期的用户特征;*预期的使用条件;*操作原则。5.2Frequently used functions 经常使用的功能The MANUFACTURER shall determine the frequently used functions t
18、hat involve USER interaction with the MEDICAL DEVICE and record them in the USABILITY ENGINEERING FILE.制造商应确定涉及医疗器械用户接口的经常使用的功能,并在可用性工程文档中形成记录。5.3Identification of HAZARDS and HAZARDOUS SITUATIONS related to USABILITY与可用性有关的危害和危害处境的判定5.3.1Identification of characteristics related to SAFETY 与安全性有关的特征
19、的判定An identification of characteristics related to SAFETY (part of a RISK ANALYSIS) that focuses on USABILITY shall be performed according to ISO 14971:2007, 4.2.应按照ISO 14971:2007的4.2 判定与可用性有关的安全性特征(风险分析的一部分)。During the identification characteristics related to SAFETY, the following shall be conside
20、red: application specification, including USER PROFILE(S) (see 5.1); and frequently used functions (see 5.2).The results of this identification characteristics related to SAFETY shall be recorded in the USABILITY ENGINEERING FILE.在判定安全性特征时,应考虑下列方面:应用规范,包括用户特征(见5. 1) ;经常使用的功能(见5.2) 。安全性特征的判定结果应记录在可用性
21、文档中。5.3.2Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS已知的或可预见的危害和危害处境的判定The MANUFACTURER shall identify known or foreseeable HAZARDS (part of a RISK ANALYSIS) related to USABILITY according to ISO 14971:2007, 4.3. The identification of HAZARDS shall consider HAZARDS to PATI
22、ENTS, USERS and other persons (see Annex E and Annex F).制造商应按照ISO 14971:2007的4.3 判定和可用性有关的己知的或可预见的危害(风险分析的一部分)。危害的判定应考虑对患者、用户和其他人员的危害。(见附录E和附录F) 。Reasonably foreseeable sequences or combinations of events involving the USER INTERFACE that can result in a HAZARDOUS SITUATION associated with the MEDIC
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