ASTM F2182-19e2 PDF

Full title and description

Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging (Designation: ASTM F2182-19e2). This test method defines laboratory procedures for measuring RF‑induced temperature rise in and around passive (non‑powered) medical implants placed inside tissue‑equivalent phantoms during MRI exposure, and provides guidance for reporting measured temperature rises and associated test conditions.

Abstract

ASTM F2182-19e2 is a test method used to quantify radiofrequency (RF)‑induced heating produced by MRI systems on or near passive implants. The method specifies phantom preparation (gelled‑saline tissue simulant), implant mounting, RF exposure conditions (typical focus on 1.5 T and 3 T systems), temperature probe placement and measurement procedures, and uncertainty considerations. Results are used to characterize an implant’s heating propensity and may be combined with computational models to assess patient risk and support regulatory submissions.

General information

• Status: Active (current test method edition designated F2182-19e2).
• Publication date: 15 September 2019 (designation indicates 2019 edition, with editorial amendments noted in the e2 release).
• 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; MRI safety / implant testing domain).
• Edition / version: F2182-19e2 (2019 edition, editorial changes included in e2).
• Number of pages: Approximately 11 pages (published test method length may vary slightly by vendor format).

Scope

This test method covers laboratory measurement of RF‑induced heating on or near passive (non‑powered) implants placed in a tissue‑equivalent phantom during MRI. It is intended to characterize additional local temperature rise (∆T) and provide measurements that can be used alone or as inputs to computational models for estimating patient heating. The method focuses on whole‑body MRI transmit systems (typical use at 1.5 T and 3 T) and does not itself set safety acceptance limits — users and regulators must define acceptance criteria. Testing for implants with implantation conditions outside the assumed fully‑internal geometry (for example percutaneous leads, tethered probes, external fixation) may require method modification.

Key topics and requirements

• Phantom medium: preparation and characterization of gelled‑saline tissue‑equivalent phantom (electrical and thermal properties specified).
• Implant positioning: standardized mounting and geometry within the phantom to locate likely “hot‑spot” regions for temperature measurement.
• RF exposure characterization: test field/frequency selection (commonly 64 MHz for 1.5 T and 128 MHz for 3 T), coil/excitation description, and normalization to specified incident field or SAR levels.
• Temperature measurement: probe types, placement, sampling intervals and procedures to measure local ∆T on/near the implant.
• Reporting and uncertainty: required test conditions, measurement uncertainty statements, and formats for reporting ∆T and associated exposure parameters.
• Limits and applicability: the method characterizes heating propensity but does not prescribe safe heating thresholds — intended to support risk assessment and regulatory submissions.

Typical use and users

Primary users are medical device manufacturers (implants and leads), independent test laboratories, MR safety engineers, and regulatory affairs specialists preparing MRI‑safety information for product labeling or regulatory filings. Researchers and computational modelers also use the method to validate numerical predictions of implant heating. Test results are used to inform device MRI labeling (e.g., MR‑Safe / MR‑Conditional statements when combined with other safety tests) and to support clinical risk assessments.

Related standards

Standards and practices commonly referenced together with ASTM F2182 include: - ISO/TS 10974 (Assessment of the safety of MRI for patients with active implantable medical devices), - IEC 60601‑2‑33 (safety requirements for MR equipment), - ASTM F2052 (measurement of magnetically induced displacement force), - ASTM F2119 (evaluation of MR image artifacts from passive implants), and - ASTM F2503 (marking medical devices for safety in the MR environment). These documents address complementary hazards (forces, torque, artifacts, marking and active‑device assessments) and are often used together in an MR‑safety evaluation program.

Keywords

RF heating; MRI; implant heating; phantom; gelled‑saline; specific absorption rate (SAR); temperature rise; MR safety; passive implant; test method; ASTM F2182-19e2.

FAQ

Q: What is this standard?

A: ASTM F2182-19e2 is a laboratory test method for measuring radiofrequency‑induced temperature rise on or near passive (non‑powered) medical implants when exposed to MRI electromagnetic fields. It documents phantom methods, probe placement, exposure characterization and reporting.

Q: What does it cover?

A: It covers preparation of tissue‑equivalent phantoms, implant mounting, RF exposure conditions (commonly relevant to 1.5 T and 3 T MRI), temperature probe usage, measurement procedures, uncertainty reporting, and recommended formats for reporting measured ∆T. It does not set allowable patient safety limits — those are defined by users/regulators.

Q: Who typically uses it?

A: Device manufacturers, independent test labs, MR safety engineers, researchers, and regulatory specialists use it to evaluate implant heating propensity and to support labeling and regulatory submissions.

Q: Is it current or superseded?

A: The F2182-19e2 edition (2019, e2 editorial changes) is the published 2019 edition noted in standards catalogs and remains the referenced ASTM test method for RF‑induced heating of passive implants; users should check ASTM International for any later revisions or corrigenda before relying on the text for formal testing.

Q: Is it part of a series?

A: It is part of the MRI safety test methods developed under ASTM Committee F04 (Medical and Surgical Materials and Devices, Subcommittee F04.15). It is commonly used alongside other ASTM MR test methods (e.g., F2052, F2119, F2503) and international standards (ISO/TS 10974, IEC 60601‑2‑33) to provide a comprehensive MR‑safety evaluation.

Q: What are the key keywords?

A: RF heating; MRI; phantom; gelled‑saline; implant; SAR; temperature rise; MR safety; passive implant; test method (ASTM F2182-19e2).