ASTM F1929-23: TMV Dye Penetration Test
Start here: TMV Step-by-Step Guide
View alStart 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
TMV Protocol: Dye Penetration Test acc. to ASTM F1929-23
View alPlease download the TMV protocol to edit it.
Watch the video to learn how to fill out the TMV protocol template correctly. Use the TMV protocol template and customize it according to your needs.
TMV Assessment Form: Dye Penetration Test acc. to ASTM F1929-23
View alIn this video, we will walk you through the assessment form for the Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration according to ASTM F1929-23. Simon will explain what you need to fill in to create a compliant documentation. If you have any specific questions to this video, please contact us at office@sifo-medical.com. office@sifo-medical.com.
Please download the document to edit it.
Raw Data Analysis: How to Organize Raw Data in Excel
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Learn how to organize your raw data (attribute data) in Excel. In this example, we use 3 operators (A, B, C), who test 15 parts each and perform 2 trials, i.e., we have 90 assessments. Watch the video for a detailed explanation of how to correctly organize your data in Excel.
How to Analyze Your Data in Minitab
View alLearn how to analyze your data in Minitab. In the case of a dye penetration test, we perform an Attribute Agreement Analysis.
TMV Report: Dye Penetration Test acc. to ASTM F1929-23
View alPlease download the document to edit it.
You record your results from the analysis in the final document, the TMV Report. Watch the video for a detailed explanation of how to correctly complete the Test Method Validation Report for the Dye Penetration Test according to ASTM F1929.
BONUS
View alUse 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.
Use a decision tree to prove the intended purpose of your test method.