Definition needed in ISO13485 - 7.5.1.1 b) - Reference Measurement Procedures

[RCW]

Does anybody have a good example of what "reference measurement procedures" are? (This is from ISO13485 - 7.5.1.1 b).) I didn't see anything in ISO 14969 to clarify.

It's Friday afternoon and I'm drawing a blank.

Thanks!

[Al Rosen]

In Reply to Parent Post by RCW

Does anybody have a good example of what "reference measurement procedures" are? (This is from ISO13485 - 7.5.1.1 b).) I didn't see anything in ISO 14969 to clarify.

It's Friday afternoon and I'm drawing a blank.

Thanks!

If you don't know, then you probably don't need to concern yourself with it. If you are involved with IVDs then you will need to look at ISO 15193, In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Presentation of reference measurement procedures.

[RCW]

Nope. No In Vitro stuff here.....yet.

Thanks Al!

[DaveDavis]

Me thinks that reference materials may also be those items used in production and servicing for "calibration" or application of settings, etc. A good example might be biological or non-biological specimens for IVDs but my also include color charts, USAF resolution targets, depth of field target charts, etc. Ya' know, reference stuff!

"Like Home Depot, always here to help"

Dave