CE-可用性工程评估报告(EN62366).doc

EN 62366:2008 Checklist/检查表

Medical devices

Application of usability engineering to medical

devices 可用性工程于医疗器械的应用

Product Name/产品名称

Report Reference No/编号.:

Version/ 版本号：

验证人：

Date of issue/发布日期:

版本修改记录：

日期版本说明验证人审批人

4

GENERAL REQUIREMENTS/ 总要求

General Requirements/ 总要求

E

P ROCESS /可用性工程过程 NGINEERING

Has the

MANUFACTURER

established, documented

User Manual;

Compliance

and maintained a USABILITY ENGINEERING PROCESS

to Quality manual, procedure

PATIENT , USER and others

provide S AFETY for the

document;

related to USABILITY for the product

制造商是否建立、记录并维持了一个可用性工程过 程，以确保患者、用户和其它涉及产品适用性的人的 安全

Does the P ROCESS address USER INTERA ctions with User Manual

Compliance

the MEDICAL DEVICE according to the ACCOMPANYING

DOCUMENT

including, but not limited to transport,

storage, installation, operation, maintenance, repair and disposal

该过程是否用于解决用户按随机文件与医疗器械的 交互，如运输、存储、安装、操作、维护、维修和 废弃？

R ESIDUAL R ISKS associated with U SABILITY of the Risk analysis report ; Compliance MEDICAL

D EVIC

E presumed to be acceptable, unless

there is OBJECTIVE EVIDENCE to the contrary and documented

关系医疗器械可用性的剩余风险是否推定可接受？

MANUFACTURER SHALL subject the information for Risk analysis report ; Compliance

safety used as a RISK CONTROL to the USABILITY User Manual;

ENGINEERING PROCESS ., warnings or limitation of

use in the ACCOMPANYING DOCUMENTS , marking, etc.).

对于做为风险控制措施的安全信息，制造商应把它纳 入可用性工程过程的控制

Disregarding such information for SAFETY

is Risk analysis report

Compliance

considered beyond any further reasonable means of

RISK CONTROL

忽视安全信息的行为应被认为是超出风险控制措施的 （即非正常使用）

The results of the are recorded in the

USABILITY ENGINEERING PROCESS

USABILITY ENGINEERING FILE

Quality manual, procedure Compliance

document;

可用性工程过程的结果记录于可用性工程文档。

The records and other documents that make up the Quality manual, procedure

document

USABILITY ENGINEERING FILE MAY form part of other documents and files ., a MANUFACTURER ’S product design file or RISK MANAGEMENT FILE ),

(SEE

List of documents make up the UE file)

组成可用性工程文档的记录和其它文件可以是其它文 档（如技术文档和风险管理文档）的一部分

Scaling of the U SABILITY E NGINEERING effort/ 可用性工程的调整 The USABILITY ENGINEERING PROCESS is scaled based Risk analysis report

on the significance of any modifications depending on the results of the RISK ANALYSIS and documented 可用性工程调整取决于风险分析确认的设计更改的重

要程度

5

USABILTY ENGINEERING PROCESS/ 可用性工程过程

Application specification/

应用的规格

Application of M EDICAL D EVICE in the USABILITY

-

ENGINEERING FILE is specified by the MANUFACTURER and includes

Compliance

Compliance

-

可用性工程文档中的医疗器械的应用由制造商决定，包括：

–intended medical indication ., conditions(s) or disease(s) to be screened, monitored, treated, diagnosed, or prevented);

预期医学用途，如预期要筛查、监护、治疗、诊断或预防的状态或疾病；

–intended

PATIENT

population ., age, weight,

health, condition);

预期患者群，如年龄、体重、健康和社会条件；

–intended part of the body or type of tissue applied to or interacted with;

预期使用的身体部位或组织；

–intended conditions of use .. environment

including hygienic requirements, frequency of use, location, mobility); and

User Manual

User Manual User Manual

User Manual

Compliance

Compliance

Compliance

Compliance

预期的使用状态，如环境包括卫生要求、使用频度、 地点和机动性；

–operating principle(s) User Manual

操作原理

Frequently used functions/ 常用功能

Are frequently used functions that involve U SER

User Manual interaction with the M

EDICAL D EVICE

are determined and recorded in the USABILITY ENGINEERING FILE

在可用性工程文档中是否确定并记录了涉及用户与医

疗器械交互的常用功能？

Compliance

Compliance