中英文可用性评价报告评价标准.doc

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：

EN 60601-1-6
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

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：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 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.
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。

EN 62366
Clause
Requirement + Test
Result - Remark
Verdict
4
GENERAL REQUIREMENTS总要求

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) :
运输；
储存；
安装；
操作；
维护和维修；
处置。

4.1.2
Residual risk 剩余风险

If the USABILITY ENGINEERING PROCESS detailed in this International 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 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。

4.1.3
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.
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 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 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 DEVICE 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。

5
USABILTY ENGINEERING PROCESS可用性工程过程

5.1
Application 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 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。

5.2
Frequently used functions 经常使用的功能

The MANUFACTURER shall determine the frequently used functions that 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。

5.3
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

5.3.1
Identification of characteristics related to SAFETY 与安全性有关的特征的判定

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 considered:
– 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文档中。

5.3.2
Identification 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 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 MEDICAL DEVICE shall 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 5.1);
– * task related 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 model of the operation of the MEDICAL DEVICE can cause a USE ERROR resulting in a HAZARDOUS SITUATION; and
– * 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。

5.4
PRIMARY OPERATING FUNCTIONS基本操作功能

The MANUFACTURER shall determine the PRIMARY OPERATING FUNCTIONS 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); and
– 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。

5.5
Usability Specification 可用性规范

The MANUFACTURER shall develop the USABILITY SPECIFICATION. The USABILITY SPECIFICATION
shall provide:
– testable requirements for USABILITY VERIFICATION; and
– testable requirements for USABILITY of the PRIMARY OPERATING FUNCTIONS including criteria for determining the adequacy of RISK CONTROL 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 (see 5.4);
– HAZARDS and HAZARDOUS SITUATIONS related to USABILITY (see 5.3); and
– 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. 1) ;
—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 PRIMARY OPERATING FUNCTIONS, including;
– * frequent USE SCENARIOS; and

– 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.
可用性规范至少应描述：
—与基本操作功能有关的使用情景，包括：
—*经常的使用情景；
—合理可预见的最坏的使用情景/方案；
—基本操作功能的用户接口要求，包括降低风险的要求等；
—决定基本操作功能是否易于被用户认知的要求。

5.6
USABILITY VALIDATION plan 可用性确认计划

The MANUFACTURER shall prepare and maintain a USABILITY VALIDATION plan. The USABILITY
VALIDATION plan shall specify:
– any method used for VALIDATION of the USABILITY of the PRIMARY OPERATING FUNCTIONS;
– the criteria for determining successful VALIDATION of the USABILITY of the PRIMARY OPERATING FUNCTIONS based on the USABILITY SPECIFICATION; and
– the involvement of representative intended USERS.
制造商应制定和保持可用性确认计划。可用性确认计划应规定：
—用于基本操作功能可用性确认的方法；
—决定基于可用性规范的基本操作功能可用性成功确认的判定准则；
—有代表性的预期用户的参与。

USABILITY VALIDATION methods may be quantitative or qualitative. USABILITY VALIDATION may be performed in a laboratory setting, in a simulated use environment or in the actual use environment.
可用性确认方法可以是定量的或定性的。可用性确认可以在实验室、模拟的使用环境或实际的使用环境中实施。

The USABILITY VALIDATION plan shall address:
– frequent USE SCENARIOS, and
– reasonably foreseeable worst case USE SCENARIOS,
that are identified in the USABILITY SPECIFICATION.
The USABILITY VALIDATION plan shall be recorded in the USABILITY ENGINEERING FILE.
可用性确认计划应阐述：
—经常的使用情景
—合理可预见的最坏的使用情景
上述内容的识别见可用性规范。
可用性确认计划应记录在可用性工程文档中。

5.7
USER INTERFACE design and implementation 用户接口的设计和实施

The MANUFACTURER shall design and implement the USER INTERFACE as described in the USABILITY SPECIFICATION utilizing, as appropriate, USABILITY ENGINEERING methods and techniques.
制造商应设计和实施可用性规范中描述的用户接口，适当时，利用可用性工程的方法和技术。

5.8
USABILITY VERIFICATION 可用性验证

As part of the MEDICAL DEVICE design VERIFICATION PROCESS, the MANUFACTURER shall VERIFY the implementation of the MEDICAL DEVICE USER INTERFACE design against the requirements of the USABILITY SPECIFICATION. The results of the VERIFICATION shall be recorded in USABILITY ENGINEERING FILE.
作为医疗器械设计验证过程的一部分，制造商应按照可用性规范要求验证医疗器械用户接口设计的实施。验证结果应记录在可用性工程文档中。

5.9
USABILITY VALIDATION 可用性确认

The MANUFACTURER shall VALIDATE USABILITY of the MEDICAL DEVICE according to the USABILITY VALIDATION plan. The results shall be recorded in the USABILITY ENGINEERING FILE.
制造商应按照可用性确认计划对医疗器械的可用性进行确认。其结果应记录在可用性工程文档中。

If the acceptance criteria documented in the USABILITY VALIDATION plan are not met:
– further USER INTERFACE design and implementation activities shall be performed (see 5.6); or
– if further improvement is not practicable, the MANUFACTURER may gather and review data and literature to determine if the medical benefits of the INTENDED USE outweigh the RISK arising from USABILITY problems. If this evidence does not support the conclusion that the MEDICAL benefits outweigh the RISK, then the RISK is unacceptable.
如果不满足在可用性确认计划中形成文件的验收准则：
—应进行进一步的用户接口设计和实施活动(见5.6) ;或
—如果进一步的改进是不可行的，制造商可收集资料和文献并进行评审以确定是否预期用途的医疗受益超过了可用性问题引起的风险。如果此证据不支持医疗受益超过风险的结论，则风险是不可接受的。

6
ACCOMPANYING DOCUMENT随附文件

If provided, the ACCOMPANYING DOCUMENT shall be written at a level consistent with the USER PROFILE.
如果提供随附文件，随附文件的复杂程度应和用户特征相适应

The ACCOMPANYING DOCUMENT may be provided electronically. If the ACCOMPANYING DOCUMENT is provided electronically, the USABILITY ENGINEERING PROCESS shall include consideration of which information also needs to be provided as hard copy or as markings on the MEDICAL DEVICE.
随附文件可提供电子版。如果随附文件是以电子版提供，可用性工程过程应考虑哪些信息还需要以硬拷贝或医疗器械上的标记的方式来提供。

7
Training and materials for training 培训和培训资料

If training on the specific MEDICAL DEVICE is required for the safe and effective use of a PRIMARY OPERATING FUNCTION by the intended USER, the MANUFACTURER shall do at least one of the following:
– provide the materials necessary for training;
– ensure that the materials necessary for training are available; or
– provide the training.
如果为了预期用户安全、有效地使用基本操作功能而要求特定医疗器械的培训，制造商应至少进行下列一项：
—提供培训必需的材料；
—确保可获得培训必需的材料；
—提供培训。

If such training is required, the ACCOMPANYING DOCUMENT shall describe the available training options and should include the suggested duration and frequency of such training.
如果这样的培训是必需的，随附文件应描述用户可获得以上哪种培训，并应当包括对这些培训所建议的持续时间和频次。

If such training is required, the INTENDED USE and USER PROFILE(S) shall be the basis for training and training material.
如果这样的培训是必需的，培训和培训材料应基于预期用途和用户特征。