Do Test Methods completed to a standard require validation?

[d.conroy]

My company designs and manufactures wound dressings.

We complete a range of dressing adhesion and moisture absorption tests that are taken directly for a an ISO standard, do these require validation under 13485?

Any suggestions welcome.

 

[Ninja]

I'm not in medical at all, so let me answer your question with questions instead...

How do you know the results you got were at all accurate or reproducible?
If you ran the test over again, would you get similar results or wildly different?
How do you know you ran the tests correctly?

 

[d.conroy]

Good questions, in general the standard has an annex addressing repeatability and reliability, where the test was performed in several labs and shown to be repeatable and repoorducable.

How do you know the results you got were at all accurate or reproducible? ---We use equipment that is as accurate as required by the standard, and it is calibrated within the correct limits of accuracy and reproducibility.

If you ran the test over again, would you get similar results or wildly different?
---We get similar results.

How do you know you ran the tests correctly?
---You never really know that unless you are repeating each sample you test. The equipment is shown to be run repeatable at annual calibration.

That's my opinion, does anyone else have an opinion?

 

[Ninja]

Good questions, in general the standard has an annex addressing repeatability and reliability, where the test was performed in several labs and shown to be repeatable and repoorducable.

That is THEIR results, not yours...they don't count (other than to show the technique is viable).

How do you know the results you got were at all accurate or reproducible? ---We use equipment that is as accurate as required by the standard, and it is calibrated within the correct limits of accuracy and reproducibility.

That means the equipment is capable of giving good data...not that your data is good...equipment vs. how equipment is used type thing...

If you ran the test over again, would you get similar results or wildly different?
---We get similar results.

Hmmm...this means you've already tested the equipment and technique together...multiple times...makes me think you've already validated it...so what are you asking?
Have you already validated it and just not called it "validation"?

How do you know you ran the tests correctly?
---You never really know that unless you are repeating each sample you test. The equipment is shown to be run repeatable at annual calibration.

You can "know it" if you put a known or standard in the mix and gotten the expected results...
Interested in others' responses...

 

[regork]

@d.conroy - IMHO, no. I would need to understand what the standard is and what the regulatory body requirements are for you to meet that standard.
Regards,
Steve

 

[Ed Panek]

This is a confusing question. If you manufacture wound dressing I sure hope you validate the dressings with real wounds at some point before shipping them globally by the truckload. Im only familiar with 60601 standards. If we test a product to the 60601 standard it passes that standard. We still need to verify and validate our device in its intended use.

 

[BradM]

My company designs and manufactures wound dressings.

We complete a range of dressing adhesion and moisture absorption tests that are taken directly for a an ISO standard, do these require validation under 13485?

Any suggestions welcome.

Some really good points made already.

I don't think you need to validate the method; but you do need to qualify your process using the method.

 

[Ninja]

but you do need to qualify your process using the method

Perfect way to put it. Well done.