IEC 62570-2025 PDF

Full title and description

St IEC 62570-2025 — Standard practice for marking medical devices and other items for safety in the magnetic resonance (MR) environment. Specifies terms, icons and recommended labeling information for items anticipated to enter the MR environment, focusing on permanent markings that communicate safety-related MR information to users.

Abstract

IEC 62570:2025 (Edition 2.0) provides a standardized practice for marking medical devices and other items with MR-related safety information using defined terms and icons. The document sets out which markings are appropriate (for example MR‑safe, MR‑conditional, MR‑unsafe), recommends the information that should accompany those markings, and specifies guidance on permanence and placement of marks. MR image artifacts are not addressed in the mandatory safety requirements.

General information

• Status: Published — International Standard (definitive edition).
• Publication date: 18 September 2025 (IEC circulation/publication 2025).
• Publisher: International Electrotechnical Commission (IEC).
• ICS / categories: 11.040.50; 11.040.55 (radiographic / diagnostic imaging equipment).
• Edition / version: Edition 2.0 (2025).
• Number of pages: 18 pages (IEC publication metadata).

Scope

This standard applies to medical devices and other items anticipated to enter the MR environment. It specifies marking by terms and icons, and recommends the information to be included in labeling to support safe use in and around MR systems. The mandatory portions do not address MR image artifacts because artifacts are not treated as direct safety issues arising from MR examination characteristics. The standard is intended for items brought into MR suites, including device components, accessories and ancillary equipment.

Key topics and requirements

• Definitions and standardized terms for MR safety status (for example MR‑safe, MR‑conditional, MR‑unsafe).
• Graphical icons and symbol specifications for consistent MR marking.
• Recommended content for labels (conditions of use, field strength limits, orientation, spatial restrictions, testing notes).
• Guidance on permanence, placement and legibility of markings for long‑term identification.
• Instructions for combining textual terms and icons to reduce misinterpretation by users and clinical staff.
• Relationship to earlier edition and harmonization with ASTM F2503 language integrated into the IEC text.

Typical use and users

Manufacturers of medical devices, device designers, product labeling and compliance teams, MR safety officers and hospital biomedical engineers, clinical users responsible for device selection in MR environments, test laboratories and conformity assessment bodies. The standard is used when developing product labels, instruction materials and internal MR safety policies.

Related standards

Revises and supersedes IEC 62570:2014; integrates the language of ASTM F2503 (MR labeling practice). It is used alongside MR equipment and safety standards (for example standards within IEC TC 62/SC 62B such as MRI equipment safety requirements) and other medical device system and labeling standards that address safety, performance and conformity assessment.

Keywords

magnetic resonance, MRI safety, MR marking, MR‑safe, MR‑conditional, MR‑unsafe, labeling, icons, medical device marking, IEC 62570, ASTM F2503.

FAQ

Q: What is this standard?

A: IEC 62570:2025 is an international standard giving practice and requirements for marking medical devices and other items for safety in the magnetic resonance environment (Edition 2.0, 2025).

Q: What does it cover?

A: It covers the terms, icons and recommended labeling information used to communicate MR safety status and conditions of use for items anticipated to enter MR environments; it recommends how markings should be applied and interpreted but does not treat MR image artifacts as mandatory safety requirements.

Q: Who typically uses it?

A: Device manufacturers, labeling and regulatory teams, MR safety officers, clinical engineers, test laboratories and standards committees involved with MR safety and device conformity.

Q: Is it current or superseded?

A: Current as of its publication in 2025 (Edition 2.0). It revises and supersedes IEC 62570:2014. Users should refer to the 2025 edition for the latest prescribed markings and guidance.

Q: Is it part of a series?

A: It is maintained by IEC technical committee TC 62, subcommittee SC 62B (medical imaging equipment) and is related to other IEC and national documents addressing MR equipment, safety and medical device labeling; it also harmonizes wording with ASTM F2503 labeling practice.

Q: What are the key keywords?

A: MR marking, MRI safety, MR‑safe, MR‑conditional, MR‑unsafe, icons, labeling, medical device marking, IEC 62570.