ISO/TS 10974:2018 PDF

Overview

ISO/TS 10974:2018 - "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device" - is a technical specification that defines type‑test methods to evaluate interactions between active implantable medical devices (AIMDs) and the electromagnetic environment of 1.5 T cylindrical whole‑body MR scanners (≈64 MHz, whole‑body coil excitation). The document focuses on implantable parts of AIMDs and is intended to support MR safety evaluations and MR Conditional labelling. Non‑implantable components and routine production tests are outside its scope.

Key topics and requirements

ISO/TS 10974:2018 organizes practical safety tests and analysis into topics including:

• RF‑induced heating: measurement and modelling approaches, a four‑tier assessment strategy, phantom and measurement system prerequisites, hot‑spot localization, power‑deposition determination, in‑vitro validation and uncertainty analysis.
• Gradient‑induced heating and vibration: test waveforms, |dB/dt| exposure limits, lab and MR scanner testing, shaker‑table methods, and test duration/temperature considerations.
• B0 (static field) effects: induced force and torque assessment and static‑field testing procedures.
• Gradient‑induced extrinsic electric potentials: pulse leakage, rectification, transient and steady‑state current measurements, and AIMD output distortion tests (tiered test approaches).
• Protection from MR‑induced malfunction: static and dynamic tests to detect functional disturbances.
• Tiered testing and modelling: guidance on Tier 1–4 strategies, when to apply measurements vs. computational modelling, and validation of in‑vitro models.
• Test reporting and compliance: content requirements for test reports, device description, test methods and results.
• Relationship to other standards (e.g., IEC 60601‑2‑33 for MR scanner safety) and responsibilities of manufacturers and regulators.

Applications and users

This technical specification is directly useful for:

• Medical device manufacturers designing and certifying implants (e.g., pacemakers, neurostimulators, implantable leads) seeking MR Conditional labelling.
• Independent test laboratories performing type tests and RF/gradient interaction measurements.
• Regulatory agencies and conformity assessment bodies that evaluate MR safety data.
• Standards and product committees that adapt tests for particular device types.

ISO/TS 10974:2018 supports risk assessment, MR safety documentation, and the selection of appropriate test tiers, modelling methodologies, and test reports required to demonstrate device performance and patient protection during MRI.

Related standards

• IEC 60601‑2‑33 (MR scanner safety requirements) - referenced for scanner safety context.
• Product‑specific standards and national regulations that define compliance criteria and clinical MR‑use protocols.