文档介绍：Risk Analysis 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 ISO 14971:2007
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。
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.
piled 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 )
Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2007, Annex )
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 use and how to use
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:ponents used
5
能量给予/源于病人:
Energy to/from patient
6
物质给予/源于病人:
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
9
用户是否需日常清洁或消毒:
routinely cleaned and disinfected by the user
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
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
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 missioning or disposal
26
安装和使用是否需特殊培训
Special training required to install or u