IEC 62570-2014 PDF

Full title and description

IEC 62570:2014 — Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. Specifies terms, icons and recommended information for permanent marking of items that may be brought into the magnetic resonance (MR) environment to support safe use and handling.

Abstract

This practice defines a system of markings (words and icons) to indicate the MR safety characteristics of medical devices and other items that are anticipated to enter the MR environment. It recommends the information to include on labels and specifies that MR image artifacts are not treated as a direct safety performance issue and therefore are not part of the mandatory requirements. The IEC edition integrates the text of ASTM F2503-13 to harmonize MR safety marking terminology.

General information

• Status: Superseded — original 2014 edition replaced by a later IEC 62570:2025 edition (new edition valid from 18 September 2025).
• Publication date: 26 February 2014.
• Publisher: International Electrotechnical Commission (IEC).
• ICS / categories: 11.040.50; 11.040.55 (radiographic and diagnostic equipment).
• Edition / version: Edition 1.0 (2014).
• Number of pages: 34 pages (IEC publication listing).

Scope

Applies to items (including medical devices and ancillary equipment) that are anticipated to enter the MR environment. The standard specifies permanent marking by means of standardized terms and icons, and recommends what information should be present on labels to communicate MR safety characteristics. The mandatory portions exclude requirements for MR image artifacts because those do not present direct safety hazards.

Key topics and requirements

• Definition and use of standardized MR-safety terms (for example MR Safe, MR Conditional, MR Unsafe) and corresponding icons.
• Requirements for permanent marking of items intended for use in the MR environment.
• Recommended content for label information (conditions, limits, testing basis and additional instructions).
• Integration/harmonization with ASTM F2503-13 labeling terminology.
• Clarification that MR image artifacts are out of the mandatory safety scope.

Typical use and users

Used by medical device manufacturers, MRI system vendors, compliance and regulatory teams, hospital biomedical engineering departments, MRI safety officers, clinical facility managers and testing laboratories to label devices and items for safe handling in MR settings and to support procurement, inventory control and clinical safety procedures.

Related standards

Harmonized/adopted regionally as EN 62570:2015 and related to ASTM F2503-13 (source of MR-safety terminology). The IEC document was developed by TC 62/SC 62B (diagnostic imaging equipment) and is incorporated into the European adoption.

Keywords

MR safety, MRI, medical device marking, MR Safe, MR Conditional, MR Unsafe, labeling, icons, ASTM F2503.

FAQ

Q: What is this standard?

A: IEC 62570:2014 is an international practice that defines how to mark medical devices and other items for safety in the magnetic resonance environment using standardized terms and icons.

Q: What does it cover?

A: It covers permanent marking (terms and icons) and recommended label information for items expected to enter MR environments; it does not mandate measures for MR image artifacts.

Q: Who typically uses it?

A: Medical device manufacturers, MRI vendors, testing laboratories, hospital safety officers and regulatory/compliance personnel use it to classify and label items for MR use.

Q: Is it current or superseded?

A: The 2014 edition remains a published IEC standard, but a newer IEC 62570:2025 edition has been published and is the current IEC edition effective from 18 September 2025; therefore the 2014 text is superseded by the 2025 edition.

Q: Is it part of a series?

A: It is produced by IEC TC 62/SC 62B for medical imaging equipment and has been adopted regionally as EN 62570:2015; it aligns with ASTM F2503-13 terminology but is a standalone practice for MR safety marking.

Q: What are the key keywords?

A: MR safety, MRI, labeling, MR Safe, MR Conditional, MR Unsafe, icons, medical devices, ASTM F2503.