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1、失效模式及后果分析(FMEA); 
2、失效树分析(FTA); 
3、上市后的监控(客户投诉情况等); 
4、临床经验 
5、根据EN14971风险分析的一些例子; 
6、器械的预期用途; 
7、预期与病人和第三者的接触; 
8、有关在器械中所使用的材料/元件的风险; 
9、供给患者或来自患者的能量; 
10、在无菌条件下生产的器械; 
11、用于改变病人环境的器械; 
12、说明用器械; 
13、用于控制其它器械或药品或与其配合使用的器械; 
14、不需要的能量或物质的输出; 
15、易受环境影响的器械; 
16、带有重要消耗品或附件的器械; 
17、必要的日常维护和校正; 
18、含有软件的器械; 
19、货架寿命有限制的器械; 
20、延迟或长期使用可能造成的影响; 
21、普通风险;

所有的适用项目必须论述包括可能的危险和降低风险的方法。

 

来源: 麦科田医疗

 

 

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