I’m working on a test method validation for measuring the tensile strength of a catheter-type medical device. Once the test method is validated, we will use the test method to measure a comparable device to set the specification for our device. The test method is taken from an international standard, ISO 10555, for measuring the peak tensile strength of catheters. The tensile tester we use is calibrated, but does require fixturing to hold the tested parts.
To demonstrate that the test is repeatable and reproducible, my plan is to perform a Gage R&R and assess the % Study Variation. A few notes:
To demonstrate that the test is repeatable and reproducible, my plan is to perform a Gage R&R and assess the % Study Variation. A few notes:
- The product we are developing comes in 3 sizes, so my plan is to use 3 samples of each size, tested by 2 operators (18 total measurements will be taken).
- The tensile test is destructive, so I’ll be making the assumption that the 6 samples tested in each grouping have the same tensile strength, and thus any differences are due to measurement or operator effects.