BS EN IEC 63322:2025 - Security of ME Equipment Containing High-Activity Sealed Radioactive Sources

Introducing the BS EN IEC 63322:2025, a comprehensive standard that addresses the security of medical equipment (ME) containing high-activity sealed radioactive sources. This essential document is designed to ensure the highest level of safety and security for equipment that plays a critical role in medical and industrial applications.

Overview

The BS EN IEC 63322:2025 standard is a pivotal resource for professionals involved in the design, manufacturing, and management of medical equipment that utilizes high-activity sealed radioactive sources. Released on September 15, 2025, this standard provides detailed guidelines and requirements to safeguard against potential security threats and ensure the safe operation of such equipment.

Key Features

• Standard Number: BS EN IEC 63322:2025
• Pages: 72
• ISBN: 978 0 539 14138 2
• Status: Standard

Why This Standard is Essential

In an era where security threats are increasingly sophisticated, the BS EN IEC 63322:2025 standard is indispensable for ensuring that medical equipment containing high-activity sealed radioactive sources is protected against unauthorized access and misuse. This standard is crucial for:

• Ensuring Patient Safety: By adhering to the guidelines, healthcare providers can minimize risks associated with the use of radioactive materials in medical treatments.
• Compliance with Regulations: This standard helps organizations comply with national and international regulations, avoiding legal and financial penalties.
• Enhancing Security Measures: It provides a framework for implementing robust security measures to protect sensitive equipment from theft or sabotage.

Who Should Use This Standard?

The BS EN IEC 63322:2025 standard is an invaluable resource for a wide range of professionals, including:

• Medical Equipment Manufacturers: To ensure their products meet the highest security standards.
• Healthcare Facilities: To implement effective security protocols for equipment containing radioactive sources.
• Regulatory Bodies: To establish and enforce security requirements for medical equipment.
• Security Consultants: To provide expert advice on safeguarding high-risk equipment.

Comprehensive Coverage

Spanning 72 pages, the BS EN IEC 63322:2025 standard offers in-depth coverage of various aspects related to the security of ME equipment. It includes:

• Risk Assessment: Guidelines for identifying and evaluating potential security threats.
• Security Controls: Recommendations for implementing physical and procedural security measures.
• Incident Response: Strategies for responding to security breaches and mitigating their impact.
• Training and Awareness: Best practices for educating staff on security protocols and procedures.

Stay Ahead with the Latest Standards

As technology and security threats evolve, staying updated with the latest standards is crucial for maintaining the integrity and safety of medical equipment. The BS EN IEC 63322:2025 standard is your go-to resource for ensuring that your equipment meets the highest security benchmarks.

Conclusion

In conclusion, the BS EN IEC 63322:2025 standard is an essential tool for anyone involved in the management, design, or regulation of medical equipment containing high-activity sealed radioactive sources. By adhering to this standard, you can ensure the safety and security of your equipment, protect patients and staff, and comply with regulatory requirements.

Invest in the security of your medical equipment today with the BS EN IEC 63322:2025 standard, and be confident in your ability to manage and mitigate security risks effectively.

BS EN IEC 63322:2025

This standard BS EN IEC 63322:2025 Security of ME equipment containing high-activity sealed radioactive sources is classified in these ICS categories:

• 11.040.01 Medical equipment in general
• 11.040.99 Other medical equipment
• 11.040.50 Radiographic equipment

IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.