IEC 60601-2-54:2022

Overview - IEC 60601-2-54:2022 (X‑ray equipment for radiography & radioscopy)

IEC 60601-2-54:2022 is the IEC particular standard that specifies basic safety and essential performance requirements for medical electrical (ME) equipment and ME systems used for projection radiography and indirect radioscopy. This second edition (2022) updates the 2009 edition and subsequent amendments to align with IEC 60601‑1:2005/AMD2:2020, introduces the specific term dosimeter, and contains editorial and technical clarifications for X‑ray imaging equipment. The standard excludes modalities such as CT, mammography, dental, radiotherapy, densitometry and radiotherapy simulators.

Key topics and technical requirements

• Radiation protection and management
  • Requirements for limiting unwanted, residual, leakage and stray radiation.
  • Rules for X‑ray field definition, beam limitation and the relationship between X‑ray field and image receptor.
• Essential performance
  • Emphasis on maintaining the clinical function under normal and single‑fault conditions (further explained in Annex AA).
• Measurement and dosimetry
  • Introduction of the specific term dosimeter and requirements for air kerma and reproducibility/linearity testing.
• Controls, indicators and labelling
  • Identification, marking and accompanying documents required for safe operation (Annex C guidance).
  • Clarifications on indicator lights to avoid conflicts with IEC 60601‑1 amendments.
• Mechanical, thermal and electrical safety
  • Protection against mechanical hazards, temperature management (with some requirements deferred to IEC 60601‑1 and IEC 60601‑2‑28), and electrical safety provisions.
• Automatic exposure controls (AEC) and image quality
  • Test procedures for AEC performance, loading conditions and reproducibility (see tables and test clauses).
• Electromagnetic compatibility (EMC)
  • Immunity and EMC tests relevant to essential performance (Clause 202 and 202.101).
• System vs equipment requirements
  • Clauses specify when requirements apply to ME equipment only or to ME systems.

Practical applications and users

Who uses IEC 60601‑2‑54:2022:

• Medical device manufacturers designing radiography and radioscopy X‑ray systems.
• Compliance engineers and test laboratories performing safety, radiation and EMC testing.
• Regulatory bodies and conformity assessment organizations reviewing device safety dossiers.
• Hospital biomedical engineers and procurement teams evaluating device safety, labelling and operational requirements.

How it’s used:

• Define design and risk controls for X‑ray systems.
• Establish test plans for radiation output, dosimetry, AEC performance and stray/leakage radiation.
• Create required markings, manuals and safety instructions for clinical use and maintenance.

Related standards

• IEC 60601‑1:2005 and its amendments (general medical electrical safety).
• IEC 60601‑2‑43 (interventional X‑ray equipment) - references applicable clauses.
• IEC 60601‑2‑28 (X‑ray tube assemblies) for thermal protection details.
• IEC TR 60788 (terms) and collateral standards IEC 60601‑1‑11 / IEC 60601‑1‑12 (when declared by the manufacturer).

Keywords: IEC 60601-2-54:2022, X‑ray equipment, radiography, radioscopy, medical electrical equipment, essential performance, radiation protection, dosimeter, EMC, AEC, device compliance.