Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
Can somebody suggest a good reference (e.g., possible metholodologies) for choosing the number of units that shoud be used for verification testing? Example of testing is:
- electrical safety or emc according to 60601-1 and 60601-1-2
- fatigue testing
Right now the best justification I have is that "the device is extremely expensive", which I don't think will work very well with the FDA reviewer.
Please let me know if you have any suggestions on guidances, standards, books, etc. that can help us build justifications for testing on a small numbers of units (or even one unit, as in the case of 60601 series).
Thanks

Hello,

I am not an expert in 60601-testing, but I have seen mainly 'type-testing' (1 device) in combination with final production acceptance tests so far.
Generally statistics play an important role in verification testing. The higher the associated risk level, the higher the amount of data points and/or samples you will need.
Check out the paper attached to my reply.

Best wishes,
Michael

------------------------------
Michael Hottner
Köln
Germany
------------------------------

Original Message:
Sent: 30-Sep-2020 10:06
From: Anonymous Member
Subject: sampling plan for verification activities

This message was posted by a user wishing to remain anonymous

Hello,
Can somebody suggest a good reference (e.g., possible metholodologies) for choosing the number of units that shoud be used for verification testing? Example of testing is:
- electrical safety or emc according to 60601-1 and 60601-1-2
- fatigue testing
Right now the best justification I have is that "the device is extremely expensive", which I don't think will work very well with the FDA reviewer.
Please let me know if you have any suggestions on guidances, standards, books, etc. that can help us build justifications for testing on a small numbers of units (or even one unit, as in the case of 60601 series).
Thanks

Are you able to characterize the expected/potential variability in the manufacturing process?​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 30-Sep-2020 13:23
From: Michael Hottner
Subject: sampling plan for verification activities

Hello,

I am not an expert in 60601-testing, but I have seen mainly 'type-testing' (1 device) in combination with final production acceptance tests so far.
Generally statistics play an important role in verification testing. The higher the associated risk level, the higher the amount of data points and/or samples you will need.
Check out the paper attached to my reply.

Best wishes,
Michael

------------------------------
Michael Hottner
Köln
Germany

Original Message:
Sent: 30-Sep-2020 10:06
From: Anonymous Member
Subject: sampling plan for verification activities

This message was posted by a user wishing to remain anonymous

Hello,
Can somebody suggest a good reference (e.g., possible metholodologies) for choosing the number of units that shoud be used for verification testing? Example of testing is:
- electrical safety or emc according to 60601-1 and 60601-1-2
- fatigue testing
Right now the best justification I have is that "the device is extremely expensive", which I don't think will work very well with the FDA reviewer.
Please let me know if you have any suggestions on guidances, standards, books, etc. that can help us build justifications for testing on a small numbers of units (or even one unit, as in the case of 60601 series).
Thanks

This message was posted by a user wishing to remain anonymous

Hi Anne, 
unfortunately not, we are behind in this type of activity. 
Any suggestion you can provide on how to assess the variability would be very helpful.

Michael, thank you a lot for the reference!

Original Message:
Sent: 01-Oct-2020 10:29
From: Anne LeBlanc
Subject: sampling plan for verification activities

Are you able to characterize the expected/potential variability in the manufacturing process?​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 30-Sep-2020 13:23
From: Michael Hottner
Subject: sampling plan for verification activities

Hello,

I am not an expert in 60601-testing, but I have seen mainly 'type-testing' (1 device) in combination with final production acceptance tests so far.
Generally statistics play an important role in verification testing. The higher the associated risk level, the higher the amount of data points and/or samples you will need.
Check out the paper attached to my reply.

Best wishes,
Michael

------------------------------
Michael Hottner
Köln
Germany

Original Message:
Sent: 30-Sep-2020 10:06
From: Anonymous Member
Subject: sampling plan for verification activities

This message was posted by a user wishing to remain anonymous

Hello,
Can somebody suggest a good reference (e.g., possible metholodologies) for choosing the number of units that shoud be used for verification testing? Example of testing is:
- electrical safety or emc according to 60601-1 and 60601-1-2
- fatigue testing
Right now the best justification I have is that "the device is extremely expensive", which I don't think will work very well with the FDA reviewer.
Please let me know if you have any suggestions on guidances, standards, books, etc. that can help us build justifications for testing on a small numbers of units (or even one unit, as in the case of 60601 series).
Thanks

We use ANSI/ASQ Z1.4/Z1.9. I've never had an auditor raise an issue to those.

------------------------------
Jeffrey Freedman
QA/RA Specialist III
Lowell MA
United States
------------------------------

Original Message:
Sent: 30-Sep-2020 10:06
From: Anonymous Member
Subject: sampling plan for verification activities

This message was posted by a user wishing to remain anonymous

Hello,
Can somebody suggest a good reference (e.g., possible metholodologies) for choosing the number of units that shoud be used for verification testing? Example of testing is:
- electrical safety or emc according to 60601-1 and 60601-1-2
- fatigue testing
Right now the best justification I have is that "the device is extremely expensive", which I don't think will work very well with the FDA reviewer.
Please let me know if you have any suggestions on guidances, standards, books, etc. that can help us build justifications for testing on a small numbers of units (or even one unit, as in the case of 60601 series).
Thanks