I am working on a medical device that falls under the scope of IEC 60601-1.
The device comes close to be under the scope of IEC 60601-2-2, but technically, the device does not meet the definition of an HF SURGICAL EQUIPMENT as defined in IEC 60601-2-2.
So, in that aspect, the device would technically not be under scope of IEC 60601-2-2, and we would not need to assess our device against IEC 60601-2-2.
But, IEC 60601-2-2 has some amendments / additions that are relevant to our device.
Has anyone been in a similar situation (not necessary the same particular standard)? If so, how did you decide whether to:
1. Claim compliance to the particular standard and rationalize why certain clauses in the particular standard are not applicable.
or
2. Do not claim compliance to the particular standard and as part of main standard, rationalize how/why certain clauses can be assessed per the particular standard.
It seems like #1 and #2 above are the only choices, but open to knowing if there might be another option to consider.
The device comes close to be under the scope of IEC 60601-2-2, but technically, the device does not meet the definition of an HF SURGICAL EQUIPMENT as defined in IEC 60601-2-2.
So, in that aspect, the device would technically not be under scope of IEC 60601-2-2, and we would not need to assess our device against IEC 60601-2-2.
But, IEC 60601-2-2 has some amendments / additions that are relevant to our device.
Has anyone been in a similar situation (not necessary the same particular standard)? If so, how did you decide whether to:
1. Claim compliance to the particular standard and rationalize why certain clauses in the particular standard are not applicable.
or
2. Do not claim compliance to the particular standard and as part of main standard, rationalize how/why certain clauses can be assessed per the particular standard.
It seems like #1 and #2 above are the only choices, but open to knowing if there might be another option to consider.