Overview
IEC 62570:2025 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment - establishes a harmonized system of terms, icons and labeling recommendations for items anticipated to enter the magnetic resonance (MR) environment. The standard applies to medical devices and other objects that may be brought into the MR suite and specifies how to mark and communicate MR safety information so users, clinicians and safety officers can make informed decisions.
Key topics and requirements
- Scope and intent
- Applies to items anticipated to enter the MR environment; mandatory portions exclude MR image artifacts (not considered a direct safety issue).
- Clear MR safety categories
- Defines and distinguishes MR Safe, MR Conditional and MR Unsafe, including that MR Conditional requires demonstrated safety within specified conditions (static field, time‑varying gradients, RF fields).
- MR marking and labeling
- Specifies use of terms and icons to mark items for MR safety.
- Recommends what information should be included in labeling (e.g., conditions for MR Conditional items, relevant test results or references).
- Allows marking on product or packaging when direct marking is impractical; package marking must clearly identify the item’s MR classification.
- Hazards and terminology
- Summarizes hazards relevant to the MR environment, such as magnetically induced displacement forces, magnetically induced torque and radiofrequency (RF)‑induced heating.
- Establishes consistent terminology to support safety communication and risk management.
- Practical guidance
- Significance and use sections explain risks that have led to injuries and deaths and how consistent marking mitigates those risks.
Applications and users
IEC 62570:2025 is relevant to:
- Medical device manufacturers and accessory suppliers - for product design, testing decisions and compliant labeling.
- Labeling and regulatory teams - to align MR safety claims and instructions with international practice.
- Hospitals, MRI safety officers and clinical users - to interpret device markings during procurement and clinical use.
- Standards bodies and test labs - for harmonized MR safety communication and conformity assessment.
Keywords: IEC 62570:2025, MR Safe, MR Conditional, MR Unsafe, magnetic resonance safety, device labeling, MR environment, RF heating, magnetically induced force.
Related standards
- IEC 60601‑2‑33 (MR equipment)
- ISO 14971 (risk management for medical devices)
- ISO/TS 10974 (active implant safety assessment)
- ASTM test methods referenced (e.g., F2052, F2182, F2213)
IEC 62570:2025 builds on ASTM F2503 and provides an internationally consistent approach to marking and labeling for MR safety.