风险分析-ISO14971-2007
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2
重叠和认知检索错误Lapses and cognitive recall errors
3
滑移和疏忽（精神或实际的）Slips and blunders (mental or physical)
Substances to /from patient
7
被加工的生物材料：
Biological materials processed
8
灭菌/用户灭菌或其它微生物控制：Sterile/Intended to be sterilized
9Hale Waihona Puke 用户是否需日常清洁或消毒：
routinely cleaned and disinfected by the user
User interface design features contribute to use error
29.2
是否在能因分心导致错误的环境中使用
Used in distraction environment
29.3
医疗器械是否有连接部分或附件
connecting parts or accessories
14
不需要的能量或物质输出：Unwanted outputs of energy or substances
15
受环境影响:（操作、运输的存储的环境，包括溢出，电能和冷却提供）Susceptible to environmental influences
16
器械是否影响环境
influence the environment
17
基本消耗品/附件Consumables/accessories associated
18
是否需要维护或校正Routine maintenance/calibration
19
是否包括软件Software
20
是否有严格的寿命周期
Restricted“shelf-life”:
21
延长/长期使用的影响
Delayed and/or long-term use effect
Initiate user actions
30
器械是否提供警报系统
Alarm system
31
故意的误用
Deliberately misused
32
器械是否持有患者的关键数据
Data critical to patient care?
33
器械是否可移动或可携带式
To be mobile or portable
29.4
是否有控制接口
control interface
29.5
器械是否显示信息
display information
29.6
器械是否由莱单控制
controlled by a menu
29.7
是否由特殊人士使用
Used by persons with special needs
29.8
是否通过用户界面来开始(控制)动作
1
不适当的标签Inadequate labeling
2
不适当的使用手册Inadequate operating instructions如：
附件技术规范不适当inadequate specification of accessories
预使用检查规范不适当inadequate specification of pre-use checks
3
对电磁干扰的敏感性Susceptibility to electromagnetic interference
4
电磁干扰的发射Emissions of electromagnetic interference
5
不充足的能量提供Inadequate supply of power
6
不充足的冷却提供inadequate supply of coolant
Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2007,Annex C.2)
以下条款，如果不适用就写NA，适用就写清楚条件，要用英文
1
预期用途和怎样使用：Intended useand how to use
RiskAnalysis Report
风险分析报告
公司名称：
Company Name:
公司地址：
Company Address:
产品：
Product:
型号：
Model:
附件:
Accessories:
标准：
Standard:
EN ISO14971：2007
结论：
Result:
所有可识别的风险都已经被评估。在采取适当的措施以降低这些风险之后，关于产品预期的应用和用途上，各种等级的风险是可以接受的。
1
电能electricity
2
辐射radiation
3
音量volume
4
压力pressure
5
医疗气体的供应supply of medical gases
6
麻醉剂的供应supply of anaesthetic agents
D6.Hazardsrelated to the use of the device and contributory factors使用器械危害及其形成因素
29
是否器械的成功使用，决定性的取决于人为因素，如用户接口
successful application of the medical device critically dependent on human factors, such as user interface
29.1
用户界面的特征能导致使用错误
10
压力(管壁破裂) Pressure(vessel rupture)
11
声压Acoustic pressure
12
振动Vibration
13
磁场Magnetic fields(e.g. MRI)
D3. Biologicalhazards生物危害
1
微生物污染Bio-contamination
2
生物不相容Bio-incompatibility
7
储存或操作偏离规定的外部环境条件
Storage or operation outside prescribed environmental conditions
8
与其它器械不相容Incompatibility with other devices
9
意外的机械危害Accidental mechanical damage
26
安装和使用是否需特殊培训
Special training required to install or use
27
如何提供安全使用的信息Information for safe use
28
新生产过程是否需建立或引入
new manufacturing processes need to be established or introduced
C7. Inappropriate, inadequate or over-complicated user interface (man/machine communication)不正确、不充分或过于复杂的用户介面（人/机交流）
1
错误或判断错误Mistakes and judgement errors
All risks associated with the identified hazards have been evaluated. After appropriate measures to reduce these risks have been taken, the overall level of risk of the product is acceptable with regard to the intended application and use of the application.
7
不正确的测量和其它方面计量Incorrectmeasurement and other metrological aspects
8
与消耗品/附件/其它器械不相容Incompatibility with consumables/accessories/other devices
9
锐边、锐角sharp edges or points
34
器械的使用是否依赖基本性能Depend on essential performance?
Letters in the first column refer to ISO 14971:2007,Annex C.2
其它重要的特征
以下的条款不适用也是NA，适用的要写清楚条件。
1
电能Electricity
10
废弃物和/或器械处置的污染Contamination due to waste products and /or device disposal
D5.Hazardsresulting from incorrect output of energy and substances不正确的能量和物质输出产生的危害
4
合理的可预见的错误使用Reasonably foreseeable misuse
5
不充分的副作用警告Insufficient warning of side effects
6
不充分的一次性使用器械重复使用后的可能危害Inadequate warning of hazards likely with re-use of single use devices
操作说明书过于复杂over-complicated operating instructions
服务和维修规范不适当inadequate specification of service and maintenance
3
由无经验或未经培训的人使用Use by unskilled/untrained personnel
2
是否植入设备：
Is implanted?
3
是否接触病人或其他人：Intended to contact patient or other person
4
所用的元件/材料：Materials/components used
5
能量给予/源于病人：
Energy to/from patient
6
物质给予/源于病人：
10
再感染，交叉感染Re-and/or cross-infection
11
致热性pyrogenicity
12
不能保持卫生安全Inability to maintain hygienic safety
13
降解Degradation
1
电磁场electromagnetic fields
2
不充足的能量或冷却提供Inadequate supply of power or coolant
10
改变病人环境：Modify patient environment
11
测量功能：
Measurements
12
器械输出的数据解释：
Interpretative
13
是否与其它药物或医疗技术联用：use in conjunction with medicines or other medical technologies
编写Compiled by:
(Name/Title/Dept.)
日期Date:
评审Reviewed by
(Name/Title/Dept.)
日期Date:
批准Approved by:
(Name/Title/Dept.)
日期Date:
特征的定性定量分析：(acc. to ISO 14971:2007,Annex C.2)
2
热Heat
3
机械力Mechanical force
4
离子辐射Ionizing radiation
5
非离子辐射Non-ionizing radiation
6
电磁场Electromagnetic fields
7
可移动部件Moving parts
8
悬浮物Suspended masses
9
支持病人器械失败Patient support device failure
3
不正确的成份(化学组成) Incorrect formulation(chemical composition)
4
毒性Toxicity
5
变态反应性allergenicity
6
诱变性mutagenicity
7
致瘤性oncogenicity
8
致畸性teratogenicity
9
致癌性Carcinogenicity
22
使用者或病人对器械机械力控制Mechanical forces
23
决定器械的寿命（包括老化）Lifetime of the device determined
24
一次性/重复使用Single use/re-use
25
是否需安全退出运行或处置
safe decommissioning or disposal
重叠和认知检索错误Lapses and cognitive recall errors
3
滑移和疏忽（精神或实际的）Slips and blunders (mental or physical)
Substances to /from patient
7
被加工的生物材料：
Biological materials processed
8
灭菌/用户灭菌或其它微生物控制：Sterile/Intended to be sterilized
9Hale Waihona Puke 用户是否需日常清洁或消毒：
routinely cleaned and disinfected by the user
User interface design features contribute to use error
29.2
是否在能因分心导致错误的环境中使用
Used in distraction environment
29.3
医疗器械是否有连接部分或附件
connecting parts or accessories
14
不需要的能量或物质输出：Unwanted outputs of energy or substances
15
受环境影响:（操作、运输的存储的环境，包括溢出，电能和冷却提供）Susceptible to environmental influences
16
器械是否影响环境
influence the environment
17
基本消耗品/附件Consumables/accessories associated
18
是否需要维护或校正Routine maintenance/calibration
19
是否包括软件Software
20
是否有严格的寿命周期
Restricted“shelf-life”:
21
延长/长期使用的影响
Delayed and/or long-term use effect
Initiate user actions
30
器械是否提供警报系统
Alarm system
31
故意的误用
Deliberately misused
32
器械是否持有患者的关键数据
Data critical to patient care?
33
器械是否可移动或可携带式
To be mobile or portable
29.4
是否有控制接口
control interface
29.5
器械是否显示信息
display information
29.6
器械是否由莱单控制
controlled by a menu
29.7
是否由特殊人士使用
Used by persons with special needs
29.8
是否通过用户界面来开始(控制)动作
1
不适当的标签Inadequate labeling
2
不适当的使用手册Inadequate operating instructions如：
附件技术规范不适当inadequate specification of accessories
预使用检查规范不适当inadequate specification of pre-use checks
3
对电磁干扰的敏感性Susceptibility to electromagnetic interference
4
电磁干扰的发射Emissions of electromagnetic interference
5
不充足的能量提供Inadequate supply of power
6
不充足的冷却提供inadequate supply of coolant
Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2007,Annex C.2)
以下条款，如果不适用就写NA，适用就写清楚条件，要用英文
1
预期用途和怎样使用：Intended useand how to use
RiskAnalysis Report
风险分析报告
公司名称：
Company Name:
公司地址：
Company Address:
产品：
Product:
型号：
Model:
附件:
Accessories:
标准：
Standard:
EN ISO14971：2007
结论：
Result:
所有可识别的风险都已经被评估。在采取适当的措施以降低这些风险之后，关于产品预期的应用和用途上，各种等级的风险是可以接受的。
1
电能electricity
2
辐射radiation
3
音量volume
4
压力pressure
5
医疗气体的供应supply of medical gases
6
麻醉剂的供应supply of anaesthetic agents
D6.Hazardsrelated to the use of the device and contributory factors使用器械危害及其形成因素
29
是否器械的成功使用，决定性的取决于人为因素，如用户接口
successful application of the medical device critically dependent on human factors, such as user interface
29.1
用户界面的特征能导致使用错误
10
压力(管壁破裂) Pressure(vessel rupture)
11
声压Acoustic pressure
12
振动Vibration
13
磁场Magnetic fields(e.g. MRI)
D3. Biologicalhazards生物危害
1
微生物污染Bio-contamination
2
生物不相容Bio-incompatibility
7
储存或操作偏离规定的外部环境条件
Storage or operation outside prescribed environmental conditions
8
与其它器械不相容Incompatibility with other devices
9
意外的机械危害Accidental mechanical damage
26
安装和使用是否需特殊培训
Special training required to install or use
27
如何提供安全使用的信息Information for safe use
28
新生产过程是否需建立或引入
new manufacturing processes need to be established or introduced
C7. Inappropriate, inadequate or over-complicated user interface (man/machine communication)不正确、不充分或过于复杂的用户介面（人/机交流）
1
错误或判断错误Mistakes and judgement errors
All risks associated with the identified hazards have been evaluated. After appropriate measures to reduce these risks have been taken, the overall level of risk of the product is acceptable with regard to the intended application and use of the application.
7
不正确的测量和其它方面计量Incorrectmeasurement and other metrological aspects
8
与消耗品/附件/其它器械不相容Incompatibility with consumables/accessories/other devices
9
锐边、锐角sharp edges or points
34
器械的使用是否依赖基本性能Depend on essential performance?
Letters in the first column refer to ISO 14971:2007,Annex C.2
其它重要的特征
以下的条款不适用也是NA，适用的要写清楚条件。
1
电能Electricity
10
废弃物和/或器械处置的污染Contamination due to waste products and /or device disposal
D5.Hazardsresulting from incorrect output of energy and substances不正确的能量和物质输出产生的危害
4
合理的可预见的错误使用Reasonably foreseeable misuse
5
不充分的副作用警告Insufficient warning of side effects
6
不充分的一次性使用器械重复使用后的可能危害Inadequate warning of hazards likely with re-use of single use devices
操作说明书过于复杂over-complicated operating instructions
服务和维修规范不适当inadequate specification of service and maintenance
3
由无经验或未经培训的人使用Use by unskilled/untrained personnel
2
是否植入设备：
Is implanted?
3
是否接触病人或其他人：Intended to contact patient or other person
4
所用的元件/材料：Materials/components used
5
能量给予/源于病人：
Energy to/from patient
6
物质给予/源于病人：
10
再感染，交叉感染Re-and/or cross-infection
11
致热性pyrogenicity
12
不能保持卫生安全Inability to maintain hygienic safety
13
降解Degradation
1
电磁场electromagnetic fields
2
不充足的能量或冷却提供Inadequate supply of power or coolant
10
改变病人环境：Modify patient environment
11
测量功能：
Measurements
12
器械输出的数据解释：
Interpretative
13
是否与其它药物或医疗技术联用：use in conjunction with medicines or other medical technologies
编写Compiled by:
(Name/Title/Dept.)
日期Date:
评审Reviewed by
(Name/Title/Dept.)
日期Date:
批准Approved by:
(Name/Title/Dept.)
日期Date:
特征的定性定量分析：(acc. to ISO 14971:2007,Annex C.2)
2
热Heat
3
机械力Mechanical force
4
离子辐射Ionizing radiation
5
非离子辐射Non-ionizing radiation
6
电磁场Electromagnetic fields
7
可移动部件Moving parts
8
悬浮物Suspended masses
9
支持病人器械失败Patient support device failure
3
不正确的成份(化学组成) Incorrect formulation(chemical composition)
4
毒性Toxicity
5
变态反应性allergenicity
6
诱变性mutagenicity
7
致瘤性oncogenicity
8
致畸性teratogenicity
9
致癌性Carcinogenicity
22
使用者或病人对器械机械力控制Mechanical forces
23
决定器械的寿命（包括老化）Lifetime of the device determined
24
一次性/重复使用Single use/re-use
25
是否需安全退出运行或处置
safe decommissioning or disposal