Hi All,
I've been going back through the standard and trying to align the documents I have prepared earlier this year, but during discussions with other stakeholders there's confusion around terminology used and how the analysis flows.
If a primary operating function is a function involving user interaction related to safety, then a function is any user interaction with the device to achieve a desired result.
Using the Primary Operating Function example of "– setting of infusion parameters (e.g. flow rate);"
How does this differ from a Task?
For analysis I'm looking to perform use-scenario task analysis, by breaking down functions into their subordinate tasks - this will allow the primary operating functions to be determined from the potential outcomes of use error if they are related to safety.
I appreciate that 62366 was originally intended for electromedical devices, being an IEC standard, and now is applicable to all devices - however the guidance in both the annexes and TR62366-2 is still heavily focussed on complex electromedical devices.
For a "basic" device, such as a single use, individually sterile packaged surgical blade, for attachment to a reusable scalpel handle;
To me the functions of the product are attachment to scalpel handle and cutting.
Would removal of the blade from the packaging be considered a function in its own right, a task within the function of attaching the blade to the handle, or a use step within the task of attaching the blade to handle, within a larger function?
If the user doesn't sanitise the sterile packaging before opening they could contaminate the blade
If the user doesn't open the sterile packaging from the correct end they could cut themselves on the blade easily
If the user can't grip the sterile packaging correctly they may not be able to open it safely at all.
Thanks,
TS.
I've been going back through the standard and trying to align the documents I have prepared earlier this year, but during discussions with other stakeholders there's confusion around terminology used and how the analysis flows.
3.11 * PRIMARY OPERATING FUNCTION
function that involves USER interaction that is related to the SAFETY of the MEDICAL DEVICE Note 1 to entry: Often a PRIMARY OPERATING FUNCTION is interacted with by a series of TASKS that can be broken down into a series of USER interactions. 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’. .
If a primary operating function is a function involving user interaction related to safety, then a function is any user interaction with the device to achieve a desired result.
Using the Primary Operating Function example of "– setting of infusion parameters (e.g. flow rate);"
How does this differ from a Task?
3.14 TASK
one or more USER interactions with a MEDICAL DEVICE to achieve a desired result Note 1 to entry: A TASK description should include the allocation of activities and operational steps between the USER and the MEDICAL DEVICE. Note 2 to entry: TASKS should not be described solely in terms of the functions or features provided by the MEDICAL DEVICE.
For analysis I'm looking to perform use-scenario task analysis, by breaking down functions into their subordinate tasks - this will allow the primary operating functions to be determined from the potential outcomes of use error if they are related to safety.
I appreciate that 62366 was originally intended for electromedical devices, being an IEC standard, and now is applicable to all devices - however the guidance in both the annexes and TR62366-2 is still heavily focussed on complex electromedical devices.
For a "basic" device, such as a single use, individually sterile packaged surgical blade, for attachment to a reusable scalpel handle;
To me the functions of the product are attachment to scalpel handle and cutting.
Would removal of the blade from the packaging be considered a function in its own right, a task within the function of attaching the blade to the handle, or a use step within the task of attaching the blade to handle, within a larger function?
If the user doesn't sanitise the sterile packaging before opening they could contaminate the blade
If the user doesn't open the sterile packaging from the correct end they could cut themselves on the blade easily
If the user can't grip the sterile packaging correctly they may not be able to open it safely at all.
Thanks,
TS.