Module 19 2021

02/06/2021

General Principles

Hazardous Situation ● Can result from normal and abnormal use of the device ● Hard to identify ● Complexities of multiple hazardous situations acting together ● Risk estimation can be difficult ● Emphasis must be on implementation of a robust system to prevent failures

Random Faults

Hazardous Situation

Systematic Faults

15

General Principles

Harm ● Consideration to safety of patient, operator, property or environment ● Hazardous situations may result in multiple harm ● Complex relationship to hazard ● Dependent on how, why, where and who uses the device

Random P Faapue lrtsCut

Something in between..??

Death

16

8