ASTM F2119-24 PDF

Full title and description

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants — ASTM F2119‑24: a concise, standardized procedure for measuring and reporting geometric distortion and signal‑loss artifacts in magnetic resonance (MR) images produced by passive medical implants.

Abstract

ASTM F2119‑24 specifies a repeatable test method to characterize MR image artifacts caused by passive implants (non‑powered devices). The method defines imaging conditions, reference imaging, image‑difference procedures, and quantitative metrics (for example artifact width) used to report the spatial extent and relative severity of artifacts under defined MR sequences and orientations. It is intended to support MR safety labeling and compatibility assessments for implants that are MR‑Safe or MR‑Conditional.

General information

• Status: Active standard (current edition).
• Publication date: May 15, 2024 (current 2024 edition commonly referenced as ASTM F2119‑24; approval/publication issued mid‑May 2024).
• Publisher: ASTM International (Committee F04 — Medical and Surgical Materials and Devices, Subcommittee F04.15).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics) — medical devices / MR compatibility testing.
• Edition / version: 2024 edition (designation F2119‑24).
• Number of pages: 4 (short test method format).

Scope

This test method characterizes distortion and signal‑loss artifacts produced in MR images by passive implants (items that function without electrical or external power). It provides a quantified measure of artifact extent under standardized imaging conditions, and applies to implants that have been established to be MR‑Safe or MR‑Conditional. The method describes imaging set‑up, required reference images, image processing (difference imaging), and measurement of artifact dimensions.

Key topics and requirements

• Definitions for image artifact metrics (e.g., artifact width: maximum distance from implant edge to artifact fringe).
• Required imaging approach: acquisition of paired reference and implant images (spin‑echo and gradient‑echo sequences under defined parameters) and orientation variations to determine worst‑case artifact.
• Image‑difference technique and thresholding rules to identify pixels considered part of an artifact (commonly defined by a specified relative intensity change versus reference image).
• Test specimen preparation and phantom requirements (positioning, orientation, and clearance in the imaging container or phantom).
• Reporting requirements: test configuration, scanner field strength and sequences, measured artifact dimensions (in mm), and any deviations from the standard procedure.
• Limitation: applies only to passive implants; it does not address heating, displacement force, or torque (separate standards cover those topics).

Typical use and users

Used by medical device manufacturers, MRI testing laboratories, regulatory affairs professionals, conformity assessment and quality engineers, and clinical safety teams to evaluate how implants affect MR image quality and to support MR‑safety labeling (MR‑Safe / MR‑Conditional statements). Radiology physicists and test houses performing MRI compatibility campaigns commonly apply the method during product development, preclinical testing, and regulatory submissions.

Related standards

Commonly referenced companion and related standards include ASTM F2182 (RF‑induced heating near passive implants), ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2503 (marking for MR safety information), IEC 60601‑2‑33 (particular requirements for MRI equipment), and ISO/TS 10974 (safety assessment for active implantable medical devices in the MR environment).

Keywords

MR image artifact, MRI compatibility, passive implant, MR‑Safe, MR‑Conditional, artifact width, image‑difference, test method, ASTM F2119‑24.

FAQ

Q: What is this standard?

A: ASTM F2119‑24 is a short test method that standardizes how to measure and report MR image artifacts produced by passive medical implants in magnetic resonance images.

Q: What does it cover?

A: It covers the imaging and image‑processing procedures needed to quantify artifact extent (distortion and signal loss) for passive implants under defined MR conditions, and specifies how to report the results; it does not address RF heating, displacement force, or torque.

Q: Who typically uses it?

A: Medical device manufacturers, MR‑compatibility testing laboratories, regulatory and quality teams, clinical physicists, and conformity assessment bodies use the method to support device labeling and safety documentation.

Q: Is it current or superseded?

A: The 2024 edition (F2119‑24) is the current active edition released in mid‑May 2024; earlier historical editions include F2119‑07 and F2119‑01.

Q: Is it part of a series?

A: It is one of several ASTM standards addressing MRI safety and compatibility for medical devices (for example F2052, F2182, F2213, F2503); together these standards cover complementary hazards and labeling practices in the MR environment.

Q: What are the key keywords?

A: Image artifact, MRI, passive implant, MR compatibility, MR‑Safe, MR‑Conditional, artifact width, test method.