ASTM F3172-15 (2021) PDF

Full title and description

ASTM F3172 −15 (Reapproved 2021) — Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices. This guide provides recommendations and practical considerations for selecting which device size(s) to test and how many samples to include when performing design verification testing on endovascular devices (for example, stents, balloons, catheters, and related delivery components). It clarifies definitions (device matrix, device size, essential design outputs), describes factors to consider when choosing test sizes, and offers statistical and sampling guidance while noting explicit limitations (it does not itself provide design validation protocols or guidance for computational-simulation sampling).

Abstract

This guide helps manufacturers and test engineers determine appropriate device size selection and sample sizes for design verification testing of endovascular devices. It recommends identifying essential design outputs (EDOs), grouping device sub‑types, and applying statistical reasoning (variable vs attribute approaches, consideration of normality) to sampling decisions. The guide flags special testing cases — for example, fatigue and shelf‑life — that may require different sampling approaches and refers readers to related practices and guides for those topics. The document was originally adopted in 2015 and reapproved in 2021.

General information

• Status: Reapproved (2015 edition reapproved in 2021) — active as of the 2021 reapproval.
• Publication date: Reapproval published/recorded in mid‑2021 (commonly listed as July 31 / August 1, 2021).
• Publisher: ASTM International (American Society for Testing and Materials).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics (medical devices / cardiovascular).
• Edition / version: F3172‑15 (designation indicates 2015 origin; reapproved 2021 — sometimes shown as F3172‑15(2021) or F3172‑15R21).
• Number of pages: 14 pages (concise guide).

Scope

The guide provides recommendation and guidance for selecting device size(s) within a device matrix and for selecting sample sizes appropriate to design verification tests of endovascular devices. It addresses how to define Essential Design Outputs (EDOs), determine representative device sizes and subgroups, and apply sampling rationale for a range of test types. It does not purport to cover design validation, does not provide sampling guidance for computational simulations (for example sensitivity or tolerance analysis), and does not replace regulatory requirements or specific standards for fatigue or shelf‑life — those subjects are noted as requiring special consideration or separate referenced practices. SI units are the standard for the document.

Key topics and requirements

• Definitions critical to testing: device matrix, device size, device subgroup, Essential Design Outputs (EDOs), design verification vs design validation.
• Framework to choose representative device sizes for verification testing based on EDOs and expected performance drivers (geometry, materials, manufacturing variations).
• Guidance on sample‑size selection: considerations for variable vs attribute data, assessment of normality, and pragmatic approaches when population parameters are unknown.
• Special testing considerations: fatigue testing and shelf‑life testing may require different sampling approaches and reference to other ASTM practices (for example Practice E739 and shelf‑life guides).
• Limitations and exclusions: not a how‑to for design validation, not a guide for DOE or computational sampling, and not intended to supplant regulatory guidance; users must consider regulatory requirements relevant to their jurisdictions.

Typical use and users

Primary users are medical device design and test engineers, regulatory affairs professionals, quality engineers, and contract testing laboratories involved with endovascular devices (stents, balloons, catheters, delivery systems). The guide is used to plan and justify the selection of device sizes and sample sizes for bench and in‑vitro design verification testing and to document rationales submitted to regulatory bodies or design history files.

Related standards

This guide references and should be used alongside other ASTM practices and guides relevant to specific test types, for example ASTM E739 (statistical analysis of fatigue data) and ASTM F2914 (identification of shelf‑life test attributes for endovascular devices), as well as other cardiovascular device standards developed by ASTM Committee F04 (Cardiovascular Standards). Users should review the referenced practices when planning tests that fall under those topics.

Keywords

endovascular devices, design verification, device size selection, sample size, device matrix, essential design outputs (EDO), statistics, normality, sampling plan, fatigue testing, shelf‑life, ASTM F3172.

FAQ

Q: What is this standard?

A: ASTM F3172 is a guide for selecting which device sizes to test and how many samples to test when performing design verification of endovascular devices (designation F3172‑15, reapproved 2021).

Q: What does it cover?

A: It covers principles and practical considerations for device size selection, defining essential design outputs and subgroups, and choosing sample sizes using statistical and engineering rationale. It explicitly does not provide design validation protocols, DOE guidance, or computational‑simulation sampling methods, and notes special cases (fatigue, shelf‑life) that may need other standards.

Q: Who typically uses it?

A: Device manufacturers (design, test and quality engineers), regulatory affairs specialists preparing verification evidence, and third‑party testing labs for planning and documenting design verification testing of endovascular products.

Q: Is it current or superseded?

A: The 2015 edition was reapproved in 2021 (often shown as F3172‑15(2021) or F3172‑15 R21). As of the 2021 reapproval the guide remained active; users should consult ASTM International for any revisions or reapprovals published after August 2021 to confirm current status.

Q: Is it part of a series?

A: It is part of ASTM Committee F04’s cardiovascular standards and is intended to be used with other ASTM practices and guides covering related test methods (for example E739 for fatigue data analysis and F2914 for shelf‑life attributes). It is a standalone guide focused on design verification sampling decisions within that suite of standards.

Q: What are the key keywords?

A: endovascular, device size, sample size, device matrix, essential design outputs, verification, statistics, sampling plan.