Hi All,
I have a question related to your interpretation of the primary operating functions (POF) in 62366-1:2015.
Clause 3.11 specifies it as safety related and close to FDA's Critical Task term. However, in note 2 below - it then completely muddies the water by stating: " Note 2 to entry: The concept of SAFETY includes loss or degradation of performance resulting in an unacceptable RISK to the PATIENT, including USE ERROR that prevents the USER from effectively using the MEDICAL DEVICE to achieve its intended medical purpose. In IEC 60601-1, this is referred to as ‘essential performance’. .".
Also the definition part has examples like "series of display screens that the USER has to navigate through..."
...To me, 'Note 2', and definition part brings the POF closer to 2007 version's frequent functions. A lot of functions are related to effective use of the medical device, but not safety related.
What has been your take on the primary operating functions?
Br,
Koskis
I have a question related to your interpretation of the primary operating functions (POF) in 62366-1:2015.
Clause 3.11 specifies it as safety related and close to FDA's Critical Task term. However, in note 2 below - it then completely muddies the water by stating: " Note 2 to entry: The concept of SAFETY includes loss or degradation of performance resulting in an unacceptable RISK to the PATIENT, including USE ERROR that prevents the USER from effectively using the MEDICAL DEVICE to achieve its intended medical purpose. In IEC 60601-1, this is referred to as ‘essential performance’. .".
Also the definition part has examples like "series of display screens that the USER has to navigate through..."
...To me, 'Note 2', and definition part brings the POF closer to 2007 version's frequent functions. A lot of functions are related to effective use of the medical device, but not safety related.
What has been your take on the primary operating functions?
Br,
Koskis