IEC 60601-2-28:2017

Overview

IEC 60601-2-28:2017 - “Medical electrical equipment - Part 2-28” - establishes the particular requirements for basic safety and essential performance of X‑ray tube assemblies intended for medical diagnosis and imaging. This third edition (2017) is a technical revision aligned with IEC 60601‑1:2005 / AMD1:2012 and adds technical improvements specific to X‑ray tube assemblies and their components.

Key topics and requirements

This particular standard supplements and, where necessary, modifies the general IEC 60601‑1 requirements to address X‑ray tube assembly risks. Major subject areas include:

• Scope and definitions specific to X‑ray tube assemblies and related components (e.g., X‑ray tube heads and source assemblies).
• Basic safety and essential performance requirements tailored to diagnostic X‑ray tube assemblies.
• Testing and classification procedures for ME (medical electrical) equipment and ME systems where applicable.
• Identification, marking and documentation requirements for safe use, maintenance and traceability.
• Protection against electrical and mechanical hazards, including construction and robustness of tube assemblies.
• Radiation protection: requirements to limit unwanted or excessive X‑ray emissions and to manage radiation‑related hazards.
• Temperature and other environmental hazard controls, including tests for excessive temperatures and thermal risks.
• Accuracy of controls and instrumentation and safeguards against hazardous outputs.
• Hazardous situations and fault conditions, with guidance on risk management and fault testing.
• Programmable Electrical Medical Systems (PEMS) considerations where relevant.
• Additional tests and annexes, for example Annex AA addressing pressure‑related risks and tube implosion/expelled‑parts testing.

Practical applications and users

IEC 60601‑2‑28 is essential for professionals involved with diagnostic imaging X‑ray tube assemblies:

• X‑ray tube manufacturers and component suppliers - for design, manufacturing and conformity assessment.
• Medical device design engineers and product managers - to integrate safety, performance and regulatory requirements.
• Test laboratories and conformity assessment bodies - for type testing and certification against IEC 60601 series requirements.
• Regulatory authorities and notified bodies - to assess device safety and market access.
• Hospital biomedical engineering, procurement and risk managers - for supplier evaluation, maintenance and safe deployment.

This standard supports product development, risk management, testing, labeling, and regulatory compliance for medical electrical equipment in diagnostic imaging.

Related standards

• General: IEC 60601‑1:2005 / AMD1:2012 (general standard for basic safety and essential performance).
• Collateral: IEC 60601‑1‑3 (applies as modified in Clause 203).
  Note: several collateral standards (e.g., IEC 60601‑1‑2, ‑1‑6, ‑1‑8, ‑1‑9, ‑1‑10, ‑1‑11, ‑1‑12) are explicitly not applicable to X‑ray tube assemblies as standalone items; see Clause 201.1.3 for details.

Keywords: IEC 60601‑2‑28, X‑ray tube assemblies, medical electrical equipment standard, diagnostic imaging safety, radiation protection, medical device compliance.