BS EN IEC 62570:2025 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

In the ever-evolving world of medical technology, ensuring the safety of medical devices in various environments is paramount. The BS EN IEC 62570:2025 standard is a comprehensive guide that addresses the critical practice of marking medical devices and other items to ensure safety within the magnetic resonance (MR) environment. Released on December 1, 2025, this standard is an essential resource for manufacturers, healthcare providers, and regulatory bodies.

Key Features of BS EN IEC 62570:2025

• Standard Number: BS EN IEC 62570:2025
• Pages: 24
• Release Date: December 1, 2025
• ISBN: 978 0 539 35805 6
• Status: Standard

Why This Standard is Essential

The magnetic resonance environment presents unique challenges due to the presence of strong magnetic fields. These fields can interact with medical devices, potentially leading to malfunctions or safety hazards. The BS EN IEC 62570:2025 standard provides a structured approach to marking medical devices, ensuring that they are easily identifiable and safe for use in MR environments.

This standard is crucial for:

• Manufacturers: Ensures that devices are designed and marked in compliance with safety regulations, reducing the risk of liability and enhancing product reliability.
• Healthcare Providers: Assists in the safe management and operation of medical devices within MR environments, protecting both patients and staff.
• Regulatory Bodies: Provides a benchmark for evaluating the safety and compliance of medical devices, facilitating the approval process.

Comprehensive Coverage

The BS EN IEC 62570:2025 standard spans 24 pages, offering detailed guidelines and best practices for marking medical devices. It covers a wide range of topics, including:

• Identification and Labeling: Guidelines for clear and consistent labeling of devices to indicate their compatibility with MR environments.
• Risk Assessment: Procedures for assessing potential risks associated with the use of devices in magnetic fields.
• Testing and Validation: Methods for testing devices to ensure they meet safety standards.
• Documentation: Requirements for maintaining comprehensive records of device specifications and safety evaluations.

Enhancing Safety and Compliance

By adhering to the BS EN IEC 62570:2025 standard, stakeholders can significantly enhance the safety and compliance of medical devices used in MR environments. This standard not only helps in mitigating risks but also promotes innovation by providing a clear framework for the development of new technologies.

Moreover, the standard supports the global harmonization of safety practices, facilitating international trade and collaboration in the medical device industry. With its detailed guidelines and practical insights, the BS EN IEC 62570:2025 standard is an invaluable tool for anyone involved in the design, manufacture, or regulation of medical devices.

Conclusion

The BS EN IEC 62570:2025 standard is a vital resource for ensuring the safety of medical devices in the magnetic resonance environment. Its comprehensive guidelines and best practices provide a solid foundation for manufacturers, healthcare providers, and regulatory bodies to enhance safety, compliance, and innovation in the medical device industry.

For those committed to advancing medical technology while prioritizing safety, the BS EN IEC 62570:2025 standard is an indispensable guide that will help navigate the complexities of the MR environment with confidence and precision.

BS EN IEC 62570:2025

This standard BS EN IEC 62570:2025 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment is classified in these ICS categories:

• 11.040.55 Diagnostic equipment
• 11.040.50 Radiographic equipment

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment. This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling. MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.