IEC 63322:2025

Overview

IEC 63322:2025 - "Security of ME equipment containing high-activity sealed radioactive sources" is an international standard that specifies security requirements for medical electrical (ME) equipment that contains high-activity sealed radioactive sources. It applies to equipment holding sources classified by the IAEA as Category 1, 2 or 3, and covers the lifecycle from insertion of the source into the ME equipment, through intended use and storage, until decommissioning and permanent source removal. The standard assigns responsibilities to both the MANUFACTURER and the RESPONSIBLE ORGANIZATION (e.g., hospitals, clinics) to minimize unauthorized access and misuse.

Key topics and technical requirements

• Scope and applicability: ME equipment with high-activity sealed sources used for medical treatment and clinical procedures; IAEA Category 1–3 sources.
• Division of responsibilities: Separate, explicit requirements for the Manufacturer (design, testing, documentation) and the Responsible Organization (site security, storage, use).
• Vulnerability assessment: Mandatory assessments by manufacturer and site to identify access pathways and reduce vulnerabilities.
• Security groups and resistance grades: Equipment is classified into security groups (A, B, C) with corresponding resistance grade requirements to physical attack.
• Physical resistance and testing: Type tests and site tests, with defined test grades and procedures to demonstrate compliance; Annexes include test specifications, attack-tool tables and anchoring tests.
• Intrusion detection and interfaces: Requirements for intrusion detection on ME equipment and interoperability with organizational security systems.
• Secure locations and access control: Rules for secure rooms, access control systems, markings, emergency procedures and site security manuals.
• Documentation and marking: Manufacturer-supplied site security guide, technical documentation and compliant markings.

Keywords: IEC 63322, medical equipment security, sealed radioactive source security, high-activity sources, vulnerability assessment, resistance grade, intrusion detection.

Practical applications and users

IEC 63322 is intended for:

• Manufacturers of ME equipment with sealed radioactive sources - to design, test and document compliant security arrangements.
• Healthcare providers and Responsible Organizations (hospitals, radiotherapy centers, nuclear medicine departments) - to implement site security, access control, emergency procedures and maintain compliant storage/use.
• Regulators and certification bodies - to assess conformity and review security measures for Category 1–3 sources.
• Testing laboratories and security engineers - to perform type/site tests and evaluate physical resistance and intrusion detection interfaces.

Implementing IEC 63322 improves protection of high-activity sealed sources, reduces theft/diversion risk, and provides a standardized basis for regulatory compliance and procurement.

Related standards

• IAEA categorization of radioactive sources (Category 1–3) - referenced in scope.
• EN 1143-1:2019 - relationship and testing correlations are addressed in Annex B of IEC 63322.