中英文可用性评价报告评价标准
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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.
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 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.
– * 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。
5.2
Frequently used functions经常使用的功能
TheMANUFACTURERshall determine the frequently used functions that involveUSERinteraction with theMEDICAL DEVICEand record them in theUSABILITY ENGINEERING FILE.
可用性工程过程的结果应记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。
4.3
Scaling of theUsability Engineeringeffort可用性工程工作范围界定
TheUSABILITY ENGINEERING PROCESSmay vary in form and extent based on the nature of theMEDICAL DEVICE, its intendedUSERand itsINTENDED USE(see D.3.2). In the case of the modification of aMEDICAL DEVICEdesign, theUSABILITY ENGINEERING PROCESSmay be scaledup or scaled-down based on the significance of the modification as determined by the results of theRISK ANALYSIS(see D.3.2.2).
Result - Remark
Verdict
4
总要求
4.1
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.
Medical electrical equipment
Part 1-6: General requirements for safety - Collateral Standard: Usability
Medical devices
Application of usability engineering to medical devices
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。
5
5.1
Application specification应用规范
TheMANUFACTURERshall specify the application of theMEDICAL DEVICEin theUSABILITY ENGINEERING FILE.
使用说明应包含一个应用规范的总结。
EN62366
Clause
Requirement + Test
Result - Remark
Verdict
4
4.1
General Requirements总要求
4.1.1
Usability 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 DOCUMENT, including, but not 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) :
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。
4.2
Usability Engineering File可用性工程文挡
The results of theUSABILITY ENGINEERING PROCESSshall be recorded in theUSABILITY ENGINEERING FILE. TheRECORDSand other documents that form theUSABILITY ENGINEERING FILEmay form part of other documents and files.
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:
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.
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 body or type of tissue applied to or interacted with;
运输；
储存；
安装；Biblioteka Baidu
操作；
维护和维修；
处置。
4.1.2
Residualrisk剩余风险
If theUSABILITY ENGINEERING PROCESSdetailed in this International Standard has been complied with and the acceptance criteria documented in theUSABILITY VALIDATIONplan have been met (see 5.9), then, for the purposes of ISO 14971, theRESIDUAL RISKSassociated withUSABILITYof theMEDICAL DEVICEshall be presumed to be acceptable, unless there isOBJECTIVEEVIDENCEto the contrary.
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
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.
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。
4.1.3
Information forSafety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.
ReportReference No.:
Compiled by (+ signature):
Approved by (+ signature):
Date of issue:
Company name:
Address:
Test specification:
Standard:
EN 606011-6:2010, EN 62366:2008
- test object does meet the requirement:
Pass (P)
- test object does not meet the requirement:
Fail (F)
Test Result:
Passed
EN60601-1-6
Clause
Requirement + Test
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。
5.3
Identification 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
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.
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 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.
– * 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。
5.2
Frequently used functions经常使用的功能
TheMANUFACTURERshall determine the frequently used functions that involveUSERinteraction with theMEDICAL DEVICEand record them in theUSABILITY ENGINEERING FILE.
可用性工程过程的结果应记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。
4.3
Scaling of theUsability Engineeringeffort可用性工程工作范围界定
TheUSABILITY ENGINEERING PROCESSmay vary in form and extent based on the nature of theMEDICAL DEVICE, its intendedUSERand itsINTENDED USE(see D.3.2). In the case of the modification of aMEDICAL DEVICEdesign, theUSABILITY ENGINEERING PROCESSmay be scaledup or scaled-down based on the significance of the modification as determined by the results of theRISK ANALYSIS(see D.3.2.2).
Result - Remark
Verdict
4
总要求
4.1
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.
Medical electrical equipment
Part 1-6: General requirements for safety - Collateral Standard: Usability
Medical devices
Application of usability engineering to medical devices
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。
5
5.1
Application specification应用规范
TheMANUFACTURERshall specify the application of theMEDICAL DEVICEin theUSABILITY ENGINEERING FILE.
使用说明应包含一个应用规范的总结。
EN62366
Clause
Requirement + Test
Result - Remark
Verdict
4
4.1
General Requirements总要求
4.1.1
Usability 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 DOCUMENT, including, but not 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) :
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。
4.2
Usability Engineering File可用性工程文挡
The results of theUSABILITY ENGINEERING PROCESSshall be recorded in theUSABILITY ENGINEERING FILE. TheRECORDSand other documents that form theUSABILITY ENGINEERING FILEmay form part of other documents and files.
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:
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.
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 body or type of tissue applied to or interacted with;
运输；
储存；
安装；Biblioteka Baidu
操作；
维护和维修；
处置。
4.1.2
Residualrisk剩余风险
If theUSABILITY ENGINEERING PROCESSdetailed in this International Standard has been complied with and the acceptance criteria documented in theUSABILITY VALIDATIONplan have been met (see 5.9), then, for the purposes of ISO 14971, theRESIDUAL RISKSassociated withUSABILITYof theMEDICAL DEVICEshall be presumed to be acceptable, unless there isOBJECTIVEEVIDENCEto the contrary.
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
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.
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。
4.1.3
Information forSafety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.
ReportReference No.:
Compiled by (+ signature):
Approved by (+ signature):
Date of issue:
Company name:
Address:
Test specification:
Standard:
EN 606011-6:2010, EN 62366:2008
- test object does meet the requirement:
Pass (P)
- test object does not meet the requirement:
Fail (F)
Test Result:
Passed
EN60601-1-6
Clause
Requirement + Test
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。
5.3
Identification 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