ISO TS 10974-2018 PDF

Full title and description

ISO/TS 10974:2018 — Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. This technical specification defines type-test methods and evaluation approaches to characterise interactions between active implantable medical devices (implantable parts) and the magnetic and electromagnetic fields of whole-body MR scanners (1.5 T, cylindrical bore, ~64 MHz, whole-body coil excitation), to support MR‑conditional labelling and risk assessment for AIMDs.

Abstract

ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical devices (AIMDs) intended for patients who undergo MR scans in 1.5 T cylindrical whole‑body MR scanners. It specifies type tests to characterise device interactions with static, gradient and RF fields, and provides methods that can be used to demonstrate device operation consistent with MR Conditional labelling. The document excludes non‑implantable parts and is limited to AIMDs that do not use sensing functions (or are programmed not to use sensing during MR) to affect therapy delivery.

General information

• Status: Published.
• Publication date: April 2018 (Edition 2, 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 2 (2018).
• Number of pages: 214 (as published).

Scope

The scope covers type-test methods for implantable parts of AIMDs to evaluate risks and interactions arising from the static magnetic field (B0), time‑varying gradient fields (dB/dt), and radiofrequency (RF) fields in whole‑body MR scanners operating at 1.5 T (approx. 64 MHz). It is intended to support labelling and risk assessment for MR Conditional claims; it does not address routine production testing or non‑implantable device parts. Safety requirements for the MR scanners themselves are outside this document (see IEC 60601‑2‑33).

Key topics and requirements

• Type test methods to characterise AIMD interactions with MR magnetic and electromagnetic fields (static, gradient and RF).
• Assessment of magnetically induced forces and torques (device attraction and displacement).
• Evaluation of RF‑induced heating of implantable parts (SAR/B1-related heating tests, phantom measurements and analysis).
• Measurement and evaluation of gradient‑induced voltages and potential electromagnetic interference with device electronics and therapy delivery.
• Guidance on test set‑up, phantoms, instrumentation, and uncertainty analysis (see ISO/TR 21900:2018 for uncertainty guidance).
• Use of test results to support MR Conditional labelling, documentation and risk management decisions (manufacturer/regulator responsibility to set acceptance criteria).

Typical use and users

Manufacturers of active implantable medical devices (AIMDs) use ISO/TS 10974:2018 to design and conduct pre‑market type testing for MR safety claims, to prepare MR Conditional labelling, and to inform risk assessments. Regulatory assessors, conformity assessment bodies, test laboratories, and product committees also use the specification to interpret and harmonise MR‑safety evaluations for implantable devices.

Related standards

Relevant related documents include ISO/TR 21900:2018 (Guidance for uncertainty analysis when applying ISO/TS 10974) which provides methods for evaluating measurement and test uncertainty, and IEC 60601‑2‑33 (particular requirements for MR equipment safety) which addresses safety requirements for MR scanners themselves. ISO/TS 10974:2018 replaces the earlier ISO/TS 10974:2012 edition and is maintained by ISO/TC 150/SC 6.

Keywords

magnetic resonance imaging, MRI safety, active implantable medical device, AIMD, MR Conditional, RF heating, gradient‑induced voltages, magnetic force and torque, phantom testing, uncertainty analysis.

FAQ

Q: What is this standard?

A: ISO/TS 10974:2018 is a technical specification that defines test methods and evaluation approaches for assessing the safety of implantable parts of active implantable medical devices when patients undergo MRI scans, primarily for 1.5 T whole‑body scanners.

Q: What does it cover?

A: It covers type tests and analysis to characterise interactions with static, gradient and RF fields (including magnetically induced displacement/torque, RF‑induced heating, and gradient‑induced voltages) and provides a basis for MR Conditional labelling and risk assessment. The document excludes non‑implantable parts and AIMDs that rely on sensing functions during the scan.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory reviewers, and standards/technical committees involved in MR safety assessment and labelling for implantable medical devices.

Q: Is it current or superseded?

A: ISO/TS 10974:2018 is the current published edition (Edition 2, 2018) and was reviewed/confirmed in ISO maintenance cycles. It replaced ISO/TS 10974:2012; users should check ISO/TC publications for any ongoing revisions or future replacement drafts.

Q: Is it part of a series?

A: It is a Technical Specification developed under ISO/TC 150/SC 6 related to implants and surgical prostheses; it has a companion technical report (ISO/TR 21900:2018) for uncertainty analysis and links to standards governing MR equipment safety (IEC 60601‑2‑33).

Q: What are the key keywords?

A: MRI safety, active implantable medical device, AIMD, MR Conditional, RF heating, gradient induction, magnetic force, phantom testing, uncertainty analysis.