Identification of medical device characteristics

Identification of medical device characteristics医疗

器械特性的识别

Rev Date Name Comment

A01 XX Created

Identification of characteristics (EN ISO 14971:2012)特性识别

1 What is the intended use and how is the medical device

to be used? 医疗器械的预期用途是什么?医疗器械如何使用?

Factors that should be considered include:需要考虑到的因素包括

- what is the medical device's role relative to-医疗器械所扮演的角色与下列哪个相关

- diagnosis, prevention, monitoring, treatment or alleviation of disease,-疾病的诊断, 预防,监护,治疗或缓解

- compensation for injury or handicap or-对创伤或残疾进行补偿

- replacement or modification of anatomy, or control of Product description:产品描述Patient group:患者群User:使用者

Need for education? 需要教育

conception?-解剖过程的替代或矫正, 或妊娠控制

- what are the indications for use (e.g. patient population)?-使用指示是什么?(如患者群)

- does the medical device sustain or support life?-医疗器械是否用于生命维持?

- is special intervention necessary in the case of failure of the medical device? -如果器械失效是否有必要进行特殊的干预Environment:环境Installation? 安装

2 Is the medical device intended to be implanted? 医疗器

械是否预期用于植入

Factors that should be considered include the location of

implantation, the characteristics of the patient population,

age, weight, physical activity, the effect of ageing on implant

performance, the expected lifetime of the implant, the

reversibility of the implantation.需要考虑的因素包括植入

的位置,患者群的特点、年龄、体重、身体机能,年老对植入性

能的影响, 植入物的预期寿命, 植入物是否可取出YES/NO

Motivation/description 动机/描述

3 Is the medical device intended to be in contact with the

patient or other persons?医疗器械是否预期和患者或其他人接触?

Factors that should be considered include the nature of the

intended contact, i.e. surface contact, invasive contact, or

implantation and, for each, the period and frequency of contact 需要考虑的因素包括预期接触的性质, (即表面接触,有创接触,或者植入), 以及每种接触的时间和接触的频次. YES/NO

Motivation/description

4 What materials or components are utilized in the

medical device or are used with, or are in contact with, the medical device?在医疗器械中用到了何种材料或部件?

或何种材料或部件与医疗器械共同使用,或与产品接触

Factors that should be considered include:需要考虑的因素

- compatibility with relevant substances;-与相关物质的兼容性- compatibility with tissues or body fluids;-与组织或体液的兼容性

- whether characteristics relevant to safety are known;-与安全相关的特性是否已知

- is the device manufactured utilizing materials of animal

origin?器械制造是否使用了动物器官

5 Is energy delivered to or extracted from the patient? 是

否有能量给予患者或从患者身上获取

Factors that should be considered include:应考虑的因素

- the type of energy transferred;-能量传递的形式

- its control, quality, quantity, intensity and duration;-其控制, 质量, 数量,强度和持续时间

- whether energy levels are higher than those currently used for similar devices.-其能量等级是否高于相似医疗器械的能量等级6 Are substances delivered to or extracted from the

patient? 是否有物质提供给患者或从患者身上提取?

Factors that should be considered include应考虑的因素

- whether the substance is delivered or extracted;-物质是提供还是提取

- whether it is a single substance or range of substances;-是单一物质还是一系列物质

- the maximum and minimum transfer rates and control

thereof.-最大和最小传递率及控制

7 Are biological materials processed by the medical

device for subsequent re-use, transfusion or

transplantation?是否由医疗器械处理生物材料并用于再次使用、输送或移植

Factors that should be considered include the type of process

and substance(s) processed (e.g. auto transfusion, dialysis,

blood component or cell therapy processing).应考虑的因素包括处理的方式和被处理物质的类型(例如,自动输血,透析, 血液成分或细胞的治疗处理)

8 Is the medical device supplied sterile or intended to be

sterilized by the user, or are other microbiological

controls applicable? 医疗器械是否以无菌形式提供或预期由使用者灭菌,或采用其他微生物控制方法?

Factors that should be considered include应考虑的因素包括

- whether the medical device is intended for single use or re-use packaging;-医疗器械是预期一次性使用还是重复使用的包装形式- shelf-life issues;-货架寿命问题

- limitation on the number of re-use cycles;-重复使用次数的限制

- method of product sterilization;-产品灭菌方法

- the impact of other sterilization methods not intended by the manufacturer.-制造商预期之外的方法进行灭菌的影响

9 Is the medical device intended to be routinely cleaned

and disinfected by the user?医疗器械是否预期由用户进行常规清洁和消毒

Factors that should be considered include the types of cleaning

or disinfecting agents to be used and any limitations on the

number of cleaning cycles. The design of the medical device can influence the effectiveness of routine cleaning and disinfection.

In addition, consideration should be given to the effect of

cleaning and disinfecting agents on the safety or performance of the device.应考虑的因素包括：所使用的清洁或消毒剂的类型和消毒次数的限制。医疗器械的设计也可能影响日常清洁和消毒的有效性。此外, 还需要考虑到清洁或消毒剂对器械的安全性或

性能的影响

10 Is the medical device intended to modify the patient

environment?器械是否预期改善患者的环境

Factors that should be considered include:应考虑的因素包括

- temperature;-温度

- humidity;-湿度

- atmospheric gas composition;-大气成分

- pressure;-压力

- light.-光线

11 Are measurements taken?是否进行测量

Factors that should be considered include the variables

measured and the accuracy and the precision of the

measurement results. 需考虑的因素包括：测量的变量和测量结果的准确度和精确度

12 Is the medical device interpretative?器械是否进行分析处

理(解释)

Factors that should be considered include whether conclusions are presented by the medical device from input or acquired data, the algorithms used, and confidence limits. Special attention

should be given to unintended applications of the data or

algorithm.应考虑的因素包括:医疗器械是否由输入或获得的数据显示结论, 所使用的算法和置信界限。应特别注意非预期的算法和数据的使用

13 Is the medical device intended for use in conjunction

with other medical devices, medicines or other medical technologies?器械是否预期与其他器械,医药或医疗技术联合使用

Factors that should be considered include identifying any other medical devices, medicines or other medical technologies that

can be involved and the potential problems associated with such interactions, as well as patient compliance with the therapy.应考虑的因素包括：识别可能使用的的医疗器械,医药或其他医疗技术,与这些相互作用相关的潜在问题, 以及病人对治疗的顺从性

14 Are there unwanted outputs of energy or substances?

是否由不希望的能量或物质输出

Energy-related factors that should be considered include noise and vibration, heat, radiation (including

ionizing, non-ionizing, and ultraviolet/visible/infrared radiation), contact temperatures, leakage currents, and

electric or magnetic fields.

Substance-related factors that should be considered include substances used in manufacturing, cleaning or

testing having unwanted physiological effects if they remain in the product.

Other substance-related factors that should be considered include

discharge of chemicals, waste products,and body fluids.

应考虑的与能量相关的因素包括：噪音和振动, 热量, 辐射

(包括电离辐射,非电离辐射和紫外/可见/红外辐射), 接触温

度, 漏电流和电(磁)场。

应考虑的与物质相关的因素包括：制造、清洁或测试过程中

使用的物质, 如果继续保存在产品上可能会有不希望的生理

影响。

还应考虑的与物质相关的因素包括：化学物质、废物和体液

的排放

15 Is the medical device susceptible to environmental

influences?医疗器械是否对环境影响敏感

Factors that should be considered include the operational,

transport and storage environments. These include light,

temperature, humidity, vibrations, spillage, susceptibility to

variations in power and cooling supplies, and electromagnetic interference.应考虑的因素包括：操作、运输和储存环境。包

括：光线，温度，湿度，振动，泄漏，对能源和致冷供应的变化的敏感性，以及电磁干扰

16 Does the medical device influence the environment? 医

疗器械是否影响环境

Factors that should be considered include:应考虑的因素包括

- the effects on power and cooling supplies;-对能源和致冷供应的影响

- emission of toxic materials;-毒性物质的散发;

- the generation of electromagnetic disturbance-电磁干扰的产生

17 Are there essential consumables or accessories

associated with the medical device?医疗器械是否有与之

相关的基本耗材或附件

Factors that should be considered include specifications for such consumables or accessories and any restrictions placed upon

users in their selection of these.应考虑的因素包括:消耗品或附

件的规范以及对使用者选择它们的限制

18 Is maintenance or calibration necessary? 是否有必要进

行维护或校准

Factors that should be considered include:应考虑的因素包括

- whether maintenance or calibration are to be carried out by

the operator or user or by a specialist;-维护或校准由谁来实行,

操作者、使用者还是专家

- are special substances or equipment necessary for proper

maintenance or calibration?-适当的维护是否需要特殊的物质或设备

19 Does the medical device contain software?医疗器械是否

包括软件

Factors that should be considered include whether software is

intended to be installed, verified, modified or exchanged by the operator or user or by a specialist.应考虑的因素包括：软件预

期由谁来安装、验证、修改或更换，操作者、使用者还是专

家？

20 Does the medical device have a restricted shelf-life?医

疗器械是否有储存寿命限制

Factors that should be considered include labelling or indicators and the disposal of such medical devices when the expiration

date is reached.应考虑的因素包括：标签或指示物, 以及到达有效期的处置

21 Are there any delayed or long-term use effects?是否有

延迟或长期使用效应

Factors that should be considered include ergonomic and

cumulative effects. Examples could include pumps for saline

that corrode over time, mechanical fatigue, loosening of straps and attachments, vibration effects, labels that wear or fall off,

long term material degradation. 应考虑的因素包括：人机工程

学和累积效应。例如：盐水泵随着时间腐蚀, 机械疲劳,扎带或

附件的松动,振动效应,标签磨损或掉落,长期材料降解

22 To what mechanical forces will the medical device be

subjected?医疗器械承受何种机械力

Factors that should be considered include whether the forces to which the medical device will be subjected are under the control of the user or controlled by interaction with other persons.应考虑的因素包括：医疗器械承受的力是否在使用者的控制下或由

其他人员的相互作用来控制

23 What determines the lifetime of the medical device?什

么决定医疗器械的寿命?

Factors that should be considered include ageing and battery

depletion.应考虑到的因素包括：老化和电池损耗

24 Is the medical device intended for single use?器械是否

预期一次性使用

Factors that should be considered include: does the medical

device self-destruct after use? Is it obvious that the device has

been used?应考虑的因素包括：器械使用后是否自毁?是否能明显看出器械使用过

25 Is safe decommissioning or disposal of the medical

device necessary?器械是否需要安全的退出使用或处置

Factors that should be considered include the waste products

that are generated during the disposal of the medical device

itself. For example, does it contain toxic or hazardous material, or is the material recyclable?应考虑的因素包括：医疗器械本身进行处置时产生的废物。例如, 是否含有毒性或有害材料,材料

是否可再循环使用

26 Does installation or use of the medical device require

special training or special skills? 器械的安装或使用是否需要经过专门培训或专门的技能

Factors that should be considered include the novelty of the medical

device and the likely skill and training of the person installing the

device. 应考虑的因素包括：器械的新颖之处和安装器械的人可能具有的技能和经过的培训

27 How will information for safe use be provided? 安全使

用信息是如何提供的

Factors that should be considered include:应考虑到的因素包括- whether information will be provided directly to the end user by the manufacturer or will it involve the

participation of third parties such as installers, care providers, health care professionals or pharmacists

and whether this will have implications for training;-信息是直

接提供给最终用户还是涉及到第三方的加入（例如安装者,护理

者,保健专家或药剂师）;是否意味着需要培训

- commissioning and handing over to the end user and whether

it is likely/possible that installation can be

carried out by people without the necessary skills;-调试和移交

给最终用户;是否可能出现不具备必要技能的人进行安装的情况

- based on the expected life of the device, whether re-training or re-certification of operators or service personnel would be

required.-考虑到器械的预期寿命, 是否需要对操作者或服务人

员进行再培训或再认证

28 Will new manufacturing processes need to be

established or introduced? 是否需要建立或引入新的生产过程

Factors that should be considered include new technology or a

new scale of production. 应考虑到的因素包括：新技术或新生产规模

29 Is successful application of the medical device critically

dependent on human factors such as the user

interface?

医疗器械的成功使用,是否决定性的取决于人为因素,例如使用者

接口

29.1 Can the user interface design features contribute to use

error? 用户接口的设计特征是否可能导致使用错误

Factors that should be considered are user interface design

features that can contribute to use error.

Examples of interface design features include: control and

indicators, symbols used, ergonomic features, physical

design and layout, hierarchy of operation, menus for

software driven devices, visibility of warnings, audibility of

alarms, standardization of colour coding. 应考虑的因素包

括：可能造成使用错误的用户接口设计特征。用户接口设计

特征包括：控制和指示物(器), 使用的符号, 人机工程学特

性, 物理设计和布局, 操作的级别, 软件驱动器械的菜单,

警告的可视性, 警报的可听性, 颜色编码的标准化

29.2 Is the medical device used in an environment where

distractions can cause use error? 在器械的使用环境中, 是否会因分心而导致使用错误

Factors that should be considered include:应考虑的因素包括

- the consequence of use error;-使用错误的后果

- whether the distractions are commonplace;-是否这些导致分心的事情很平常

- whether the user can be disturbed by an infrequent distraction.

-用户是否会被不寻常的事情干扰

29.3 Does the medical device have connecting parts or

accessories? 医疗器械是否有连接部件或附件

Factors that should be considered include the possibility of

wrong connections, similarity to other products’ connections,

connection force, feedback on connection integrity, and over-

and under-tightening. 应考虑的因素包括：错误连接的可能性,

与其他产品连接的类似性, 连接力, 对连接完整性的反馈, 以

及过紧或过松

29.4 Does the medical device have a control interface? 器械

是否有控制接口

Factors that should be considered include spacing, coding,

grouping, mapping, modes of feedback, blunders, slips, control

differentiation, visibility, direction of activation or change,

whether the controls are continuous or discrete, and the

reversibility of settings or actions.应考虑的因素包括：间隔、编码、分组、图形显示、反馈模式、出错、疏忽、控制的区别、可

视性、启动或变换的方向，控制是连续的还是断续的，设定或动

作的可逆性（可取消性）

29.5 Does the medical device display information? 医疗器械

是否显示信息?

Factors that should be considered include visibility in various

environments, orientation, the visual capabilities of the user,

populations and perspectives, clarity of the presented

information, units, colour coding, and the accessibility of critical information. 应考虑的因素包括：在不同情况下的的可视性(包

括不同的环境,不同的方向,不同的使用

者视力,不同的人群和观察力),显示信息的清晰度,单位,颜色编码,

以及危急信息的可到达性。

29.6 Is the medical device controlled by a menu? 医疗器械是

否由菜单控制

Factors that should be considered include complexity and

number of layers, awareness of state, location of settings,

navigation method, number of steps per action, sequence clarity and memorization problems, and importance of control

function relative to its accessibility and the impact of deviating

from specified operating procedures.应考虑到的因素包括：层次的复杂性和层数, 状态的了解, 设置(所在)的路径, 导航方

法,每一动作的步骤数, 顺序的清晰度和记忆问题, 与其可达到

性相关的控制功能的重要性, 以及偏离指定操作规程的影响

29.7 Will the medical device be used by persons with special

needs? 医疗器械是否用于有特殊需要的人

Factors that should be considered include the user, their

mental and physical abilities, skill and training, ergonomic

aspects, the use environment, installation requirements, and

the patient's capability to control or influence the use of the

medical device. Special attention should be paid to users

with special needs, such as handicapped persons, the elderly

and children. Their special needs might include assistance

by another person to enable the use of a medical device. Is

the medical device intended to be used by individuals with

various skill levels and cultural backgrounds?应考虑的因素

包括：使用者, 他们的智力和身体能力、技能和培训, 人机

工程学, 使用境,安装要求, 以及患者控制或影响医疗器械

使用的能力。应特别注意有特殊需求的使用者,如残疾人,老

年人和儿童。他们的特殊需求可能包括在旁人帮助下使用医

疗器械。器械是否预期由不同技能水平和教育背景的人使用

29.8 Can the user interface be used to initiate user actions?

否预期由不同技能水平和教育背景的人使用

Factors that should be considered include the possibility of

initiating a deliberate action for the user to enter a

controlled operation mode, which enlarges the risks for the

patient and which creates awareness for the user for this

condition. 应考虑的因素包括：引发用户有准备的动作的开

始, 从而使其进入受控的操作模式的可能性；这扩大了患者

的风险, 并引起此状况下的使用者知晓

30 Does the medical device use an alarm system? 医疗器械

是否使用警报系统

Factors that should be considered are the risk of false

alarms, missing alarms, disconnected alarm systems,

unreliable remote alarm systems, and the medical staff’s

possibility of understanding how the alarm system works.

Guidance for alarm systems is given in IEC 60601-1-8[26].

应考虑的因素包括：误报、漏报、警报系统断开、远程警报

系统不可靠的风险, 以及医疗人员理解警报系统如何动运作

的能力。警报系统的指南见IEC 60601-1-8[26]

31 In what way(s) might the medical device be

deliberately misused? 在何种情况下医疗器械可能被有意的

误用

Factors that should be considered are incorrect use of

connectors, disabling safety features or alarms, neglect of

manufacturer's recommended maintenance.应考虑的因素

包括：使用了不正确的连接器, 使安全特征或警报失效, 忽

视了制造商的维护建议；

32 Does the medical device hold data critical to patient

care? 医疗器械是否保存对患者护理非常重要的数据

Factors that should be considered include the consequence of

the data being modified or corrupted. 应考虑的因素包括：数据被修改或破坏的后果

33 Is the medical device intended to be mobile or

portable? 医疗器械是否预期用为移动式或便携式

Factors that should be considered are the necessary grips,

handles, wheels, brakes, mechanical stability and durability.应考虑的因素包括：必要的夹具,手柄,轮子,刹车,机械稳定性和耐久性。

34 Does the use of the medical device depend on essential

performance?医疗器械的使用取决于其根本性能

Factors that should be considered are, for example, the

characteristics of the output of life-supporting devices

or the operation of an alarm.应考虑的因素, 例如, 生命支持

器械的输出特性或警报系统的运行