中英文可用性评价报告评价标准Word格式.docx

1、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 ：Passed60601-16ClauseRequirement + TestResult - RemarkVerdict4Ge

2、neral requirements总要求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

3、12.2。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 t

4、he acceptance criteria for USABILITY have been met。证明可用性已达到验收标准。4.3REPLACEMENT 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

5、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 operating principles and significant physical and performance characteristics relevant to its USABILITY。 The same information shall also be included i

6、n the technical description， if this is provided as a separate document.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。62366GENERAL REQUIREMENTS总要求4.1General Requirements总要求4.1。U

7、sability Engineering 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 DOCUMEN

8、T, including， but not limited to： transport; storage; installation；- operation; maintenance and repair；- 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.Residual risk 剩余风险If the USABILITY ENGINEERING PROCESS detailed in this Internat

9、ional Standard 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

10、 EVIDENCE 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.3 Information 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.

11、如果安全性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

12、录在可用性工程文档中。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。Scaling 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 D

13、EVICE 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。5USABIL

14、TY 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 t

15、he body or type of tissue applied to or interacted with； * intended USER PROFILE； * intended conditions of use； 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。Frequently used functions 经常使用的功能The MANUFACTURER shall determine the frequently used functions that inv

16、olve 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。Identification of characteristics related to SAFETY 与安全性有关的特征的判定An id

17、entification 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 considered： app

18、lication specification， including USER PROFILE（S） （see 5。1）; 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文档中.3.2Ident

19、ification 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 PATIENTS, USERS an

20、d 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 MEDICAL DEVICE shal

21、l be identified。 The SEVERITY of the resulting possible HARM shall be determined.应判定合理可预见的可导致和医疗器械有关的危害处境的事件序列或组合。应确定由此引起的可能损害的严重度。During the identification of HAZARDS and HAZARDOUS SITUATIONS， the following shall be considered: application specification, including USER PROFILE（S） （see 5。 * task rel

22、ated requirements； * context of use; information on HAZARDS and HAZARDOUS SITUATIONS known for existing USER INTERFACES of MEDICAL DEVICES of a similar type, if available； preliminary USE SCENARIOS； possible USE ERRORS （see C。2 for some examples of potential USE ERRORS）； * if an incorrect mental mod

23、el of the operation of the MEDICAL DEVICE can cause a USE ERROR resulting in a HAZARDOUS SITUATION; * results of the review of the USER INTERFACE （see C.4 and D。2.2）.在判定危害和危害处境期间，应考虑下列各项:应用规范，包括用户特征（见5. 1）*与工作有关的要求-使用环境相似类型医疗器械的现有用户接口的己知危害或危险处境的信息（如果有） 初步使用情景可能的使用错误（潜在使用错误治一些示例见C.2）-*医疗器械操作的二个错误的构思模

24、型是否会引起一个导致危害处境的使用错误:*用户接口的评审结果（见C。4 和D。 2. 2） 。The results of this identification of HAZARDS, HAZARDOUS SITUATIONS and SEVERITY shall be recorded in the USABILITY ENGINEERING FILE.危害、危害处境和严重度的判定结果应记录在可用性工程文档中.PRIMARY OPERATING FUNCTIONS基本操作功能The MANUFACTURER shall determine the PRIMARY OPERATING FUN

25、CTIONS and record them in the USABILITY ENGINEERING FILE。制造商应确定基本操作功能并记录在可用性工程文裆中.The inputs to the PRIMARY OPERATING FUNCTIONS shall include the following： frequently used functions （see 5.2）； functions related to SAFETY of the MEDICAL DEVICE。基本操作功能的输入应包括：经常使用的功能（见5。2） ；与医疗器械安全性有关的功能.Usability Spec

26、ification 可用性规范The MANUFACTURER shall develop the USABILITY SPECIFICATION。 The USABILITY SPECIFICATIONshall provide： testable requirements for USABILITY VERIFICATION; testable requirements for USABILITY of the PRIMARY OPERATING FUNCTIONS including criteria for determining the adequacy of RISK CONTRO

27、L achieved by the USABILITY ENGINEERING PROCESS。制造商应编制可用性规范.可用性规范应提供：-用于可用性验证的可测试的要求：对基本操作功能可用性的可测试的要求，包括通过可用性工程过程达到的风险控制充分性的判定准则.可用性规范应记录在可用性工程文挡中。可用性规范可整合到其他规范中.The inputs to the USABILITY SPECIFICATION shall include the following： application specification （see 5。1）； PRIMARY OPERATING FUNCTIONS （

28、see 5.4）; HAZARDS and HAZARDOUS SITUATIONS related to USABILITY （see 5。3）; known or foreseeable USE ERRORS associated with the MEDICAL DEVICE.可用性规范的输入应包括：应用规范（见5。基本操作功能（见5.4）与可用性有关的危害和危害处境（见5.3） ;与医疗器械有关的己知的或可预见的使用错误。The USABILITY SPECIFICATION shall describe at least： USE SCENARIOS related to the P

29、RIMARY OPERATING FUNCTIONS， including； * frequent USE SCENARIOS; reasonably foreseeable worst case USE SCENARIOS； USER INTERFACE requirements for the PRIMARY OPERATING FUNCTIONS， including those to mitigate RISK; requirements for determining whether PRIMARY OPERATING FUNCTIONS are easily recognizable by the USER。可