ASTM F2213-17 PDF

Full title and description

ASTM F2213-17 — Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. This standard defines procedures to measure the magneto-static torque generated by an MRI static magnetic field on medical devices (including implants and instrumentation) and to compare the measured torque to user-specified acceptance criteria intended to assess MR safety.

Abstract

This test method details experimental and calculation-based options for quantifying magnetically induced torque on medical devices in an MR environment. It describes multiple measurement approaches, acceptance-criterion guidance (for example, comparing measured torque to the product of the device’s longest dimension and its weight), limitations of the method, and the types of MR systems for which the methods are applicable (primarily systems with a horizontal static field). The standard is intended to be used with other MR safety tests (such as displacement force and RF heating) to produce a comprehensive MR-safety assessment.

General information

• Status: Published (current edition designated F2213-17). Users should confirm present status with ASTM as standards may be revised or withdrawn.
• Publication date: 1 September 2017 (effective date / current edition approval date).
• Publisher: ASTM International (Committee F04 — Medical and Surgical Materials and Devices; Subcommittee F04.15).
• ICS / categories: 17.220.20 (Measurement of electrical and magnetic quantities).
• Edition / version: F2213-17 (revision of earlier editions such as F2213-06/2011).
• Number of pages: Approximately 12 pages (typical published length).

Scope

This test method covers measurement of magneto-static torque produced by the static magnetic field on medical devices in the MR environment and comparison of that torque to a user-specified acceptance criterion. It does not address other MR safety issues (for example, magnetically induced deflection/translation force, RF heating, image artifacts, device malfunction, acoustic noise, or interactions among devices). The methods are oriented to MR systems with a horizontal static field; some described methods require gravity to be orthogonal to the magnetically induced torsion. Values are stated in SI units.

Key topics and requirements

• Measurement of magnetically induced (magneto-static) torque on passive and active medical devices in MRI environments.
• Multiple measurement approaches (examples include suspension, low-friction surface, torsional-spring/pulley methods, and calculation-based methods tied to displacement force measurements).
• Guidance on acceptance criteria (one common conservative criterion: maximum induced torque less than the product of the device’s longest dimension and its weight).
• Limitation statements: the standard does not alone determine full MR safety and does not address dynamic torque from eddy currents or torque induced by currents in lead wires.
• Applicability notes: certain test methods require a horizontal-field MR system; adaptations or alternative methods are described for other arrangements when possible.

Typical use and users

Manufacturers of implants and MR-conditional medical devices, independent testing laboratories, regulatory/quality teams preparing MR-safety documentation, and engineers assessing compatibility of devices with MRI systems use F2213-17 as part of a broader MR-safety test program. The standard is used together with complementary test methods (e.g., for displacement force and RF heating) to support device labeling (MR Safe / MR Conditional / MR Unsafe) and regulatory submissions.

Related standards

Commonly referenced companion standards and test methods include ASTM F2052 (measurement of magnetically induced displacement force), ASTM F2182 (RF-induced heating near passive implants), ASTM F2119 (MR image artifact evaluation), and ASTM F2503 (marking medical devices for safety in the MR environment). These standards are typically used together to provide a full MR-safety evaluation.

Keywords

magnetically induced torque, MR safety, MRI, medical implant, passive implant, magneto-static torque, MR conditional, displacement force, RF heating, ASTM F2213-17.

FAQ

Q: What is this standard?

A: ASTM F2213-17 is a test method that defines how to measure magnetically induced (magneto-static) torque on medical devices placed in the magnetic resonance environment and how to compare those measurements to an acceptance criterion used in MR-safety assessments.

Q: What does it cover?

A: It covers measurement techniques (several experimental and calculation-based methods) for magnetically induced torque produced by the MRI static field, applicability limits (primarily horizontal-field MR systems), and guidance on acceptance criteria; it does not cover other MR hazards such as RF heating or image artifacts (other standards address those topics).

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, engineers, and regulatory professionals who need to demonstrate or evaluate the MR safety/compatibility of devices (implants, instruments, or accessories) use this standard as part of an MR-safety test suite.

Q: Is it current or superseded?

A: The edition designated F2213-17 was approved and published in 2017 (effective 1 September 2017). ASTM lists the F2213-17 text in its publication records; however, aggregator listings sometimes indicate withdrawal of older editions, so users should verify the current status or any later revisions directly with ASTM before relying on it for formal compliance or regulatory submissions.

Q: Is it part of a series?

A: It is part of the family of ASTM MR-safety test methods maintained by Committee F04 (Medical and Surgical Materials and Devices). Related ASTM test methods (F2052, F2182, F2119, F2503, etc.) together form the common MR-safety testing framework.

Q: What are the key keywords?

A: magnetically induced torque, magneto-static torque, MRI, MR safety, implant testing, ASTM F2213-17.