ASTM F2914-12(2024)
Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices

Standard No.

ASTM F2914-12(2024)

Release Date

2024

Published By

American Society for Testing and Materials (ASTM)  US  /  ASTM

Latest

ASTM F2914-12(2024)

Introduction

Analysis of the core content of the standard

This guideline provides a systematic framework for selecting shelf life test attributes for intravascular device manufacturers. The standard adopts the dual question decision model (Question 1 & 2) as the evaluation basis:

Evaluation dimensions	Key considerations	Typical examples
Question 1: Do attributes change over time?	Material properties, processing technology, sterilization method, packaging system	Nylon catheter breaking strength, balloon rated burst pressure
Question 2: Do changes affect safety performance?	Clinical risk analysis, complaint history, scientific basis	Stent release force, balloon compliance

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Technological evolution and standard background

The main updates of the 2024 edition are:

• Added special considerations for degradable devices
• Strengthened risk management requirements based on ISO 14971
• Improved the sterilization process impact assessment in the decision-making process diagram

Typical application case

Shelf life study of a drug-eluting stent:

1. Confirming the glass transition temperature stability of the polymer drug delivery system by DSC analysis
2. Verifying the time-varying characteristics of the coating drug release rate by accelerated aging test
3. Establishing a temperature acceleration factor model according to ASTM F1980

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Implementation recommendations

Device type	Required attributes	Exempt attributes
Metal stent	Radial support force, fatigue performance	MR compatibility, dimensional stability
Balloon catheter	Burst pressure, pushability	Appearance of non-contact parts

Special note: Combination products (drug-device combination) require additional evaluation of the interaction between drug stability and carrier materials.

ASTM F2914-12(2024) history

• 2024 ASTM F2914-12(2024) Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices
• 2018 ASTM F2914-12(2018) Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
• 2012 ASTM F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices

Standard and Specification