Is my software in class A, B or C?

Via Scoop.ithealthcare technology

Let’s do a little experience. Imagine a thermometer, which measures body temperature, with a piece of software inside. I could demonstrate that its software is class A or class C.

 

EC 62304 defines three safety classes for software:

Class A: No injury or damage to health is possible
Class B: Non-SERIOUS INJURY is possible
Class C: Death or SERIOUS INJURY is possible

Here comes the eternal question: Which class my software belongs to?

Let’s do a little experience. Imagine a thermometer, which measures body temperature, with a piece of software inside. I could demonstrate that its software is class A or class C.

If the thermometer gives a wrong value, then the nurse is going to give a medicine to treat the fever. The wrong medicine may endanger the patient, and eventually cause death. Class C.

If the thermometer gives a wrong value, then the nurse may give a wrong treatment to the patient. However there is no chance that this may endanger the patient. Class B.

If the thermometer gives a wrong value, then the nurse is going to touch the forehead of the patient, or redo the measurement with another thermometer, or check the blood pressure of the patient to confirm the fever. No damage is possible. Class A.

Via blog.cm-dm.com

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