ASTM F3172
Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
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- Language: English
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About This Item
ASTM F3172 is the Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices. It provides practical direction for choosing verification device sizes and sample sizes during evaluation, helping teams plan testing in a consistent and technically defensible way. For endovascular device development and quality work, this guide supports more reliable design verification decisions by aligning test planning with the device under review and the intended verification goals.
Purpose of ASTM F3172
The purpose of this standard is to guide how device sizes and sample sizes are selected when verifying endovascular devices. ASTM F3172 is intended to support structured test planning so that verification activities are based on a clear rationale rather than ad hoc selection. By helping users choose appropriate device and sample sets, the guide can improve consistency across engineering, quality, and regulatory workflows. It is especially useful when a program needs a defensible approach to design verification decisions.
Common use cases of ASTM F3172
This guide is commonly used during development and verification planning for endovascular devices, particularly when teams must decide how many units to test and which device sizes should be included. It may support engineering groups, test laboratories, and quality teams that need a repeatable approach for design verification studies. ASTM F3172 is also useful when preparing documentation for product evaluation, internal review, or compliance-focused workflows tied to device performance assessment.
Why ASTM F3172 matters
ASTM F3172 matters because verification planning can influence how confidently a device design is evaluated. Clear guidance on size and sample selection helps reduce inconsistency, supports better quality control, and improves the usefulness of test results. For organizations working with endovascular devices, the standard can help make procurement, testing, and compliance activities more efficient and easier to justify. In practice, it supports more reliable decision-making and lowers the risk of weak or incomplete verification plans.
- Design verification planning
- Device size selection
- Sample size rationale
- Endovascular device evaluation
- Consistent test documentation
- Publication Date: 2021-08-10
- Publisher: ASTM
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