ASTM F88/F88M-23: TMV Seal Strength Test

Start here: Before you start validating test methods (TMV), please read through our written guide. Here we summarize the theory you need to know about TMV in a nutshell. The following content awaits you: 

- Basics: Test Methods 

- Basics: Test Method Validation

- Regulatory & Normative Requirements 

- How to prepare for your TMV. 

- Checklist: Compliant Test Method Validation

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Watch the video to learn how to fill out the TMV protocol template correctly.

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In this video, we will walk you through the assessment form for the validation of the seal strength test acc. to ASTM F88/F88M-23. 

Open the template "Assessment Form (Seal Strength Test)" and follow the instructions in the video.

In this video, we will show you how to organize your raw data in Excel. Open the Excel Sheet "TMV_RawData_variable_3O_2T_10P.xlsx". Simon will explain how you can organize your raw data to prepare it for analysis. If you have any questions to this video, please contact us at office@sifo-medical.com. office@sifo-medical.com.

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After you have organized your raw data in Excel, you can analyze it in Minitab (or any other statistics software). We use Minitab because it is the most common statistics tool in MedTech. Simon shows you how to perform a nested Gage R&R using Minitab.

Simon will guide you through the TMV report template. This is the final document in which we record the analysis results. If the total tolerance of Gage R&R is less than 30%, you have passed the validation of the test method.

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Use a decision tree to prove the intended purpose of your test method.

Use this checklist to ensure your test method validation complies with all relevant MedTech regulations and standards.

Use this checklist to ensure that you do not forget any important steps when validating your test methods.