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Understanding CSA C22.2 No. 60601-2-28-18: Safety and Performance of Diagnostic X-Ray Equipment
A Comprehensive Guide to the Canadian Adoption of IEC 60601-2-28 for Medical Electrical Equipment
Scope and Applicability
CSA C22.2 No. 60601-2-28-18 is the Canadian adoption of the international standard IEC 60601-2-28:2010, including Amendment 1:2013. This standard specifies particular requirements for the basic safety and essential performance of medical electrical equipment that is intended for the generation and application of X-rays for diagnostic purposes. It covers equipment such as X-ray generators, X-ray tubes, and integrated systems used in radiography, fluoroscopy, and computed tomography. The standard is part of the CSA C22.2 series, which harmonizes with Canadian electrical safety requirements, and it applies to both transient and permanent medical installations.
Tip: Manufacturers should note that CSA C22.2 No. 60601-2-28-18 is intended to be used in conjunction with the general standard CSA C22.2 No. 60601-1 (IEC 60601-1) — always reference both for a complete compliance framework.
Key Technical Requirements
The standard establishes requirements in several critical areas to ensure safe operation and accurate diagnostic performance. Below are the major technical categories:
Radiation Protection and Dose Control
Manufacturers must implement measures to limit unnecessary radiation exposure. This includes design requirements for beam limitation devices, accessory performance (e.g., grids, compression paddles), and integration of exposure control systems that follow the principle of as low as reasonably achievable (ALARA). The standard mandates that X-ray equipment provide clearly labeled controls and indicators for exposure parameters such as tube voltage (kV), tube current (mA), and exposure time (s).
Electrical Safety and Arcing Mitigation
Given the high voltages involved (often >100 kV), the standard requires specific clearance and creepage distances, especially in high-voltage cables and connectors. It also stipulates testing for dielectric strength and partial discharge to avoid arcing that could compromise patient safety. The equipment must withstand overvoltage conditions without causing hazardous situations.
Control Interface and Essential Performance
To maintain diagnostic accuracy, the standard sets acceptance limits for key parameters. These limits are verified under reference conditions (e.g., 0.5 mm Cu filtration, 1 m distance, standard detector). The table below summarizes typical performance requirements outlined in the standard:
| Parameter | Requirement (Reference Conditions) | Test Method |
|---|---|---|
| Accuracy of tube voltage (kV) | Within ±10% of indicated value or ±1 kV, whichever is greater | Non-invasive kV meter |
| Reproducibility of radiation output | Variation <10% over ten consecutive exposures at same settings | Ionization chamber |
| Linearity of dose with mAs | ±20% over the entire range | Multiple exposures at different mAs |
| Minimum alarm threshold | 10 μGy/h at 1 m from the X-ray source (leakage) | Survey meter |
Important: Testing must be performed with the test conditions and statistical methods defined in IEC 60601-2-28. Simply meeting the nominal values is not sufficient; the standard also requires evaluation of transient effects during the initial and final phases of an exposure.
Implementation Highlights
Implementing CSA C22.2 No. 60601-2-28-18 requires attention to both design and documentation. Manufacturers should consider the following:
- Marking and labelling — Equipment must display radiological warning labels, maximum tube voltage, and focal spot specifications. Technical descriptions must include spectral characteristics and filtration.
- Protection against electric shock — High-voltage parts must be shielded and interlocked. The standard defines limits for patient leakage current and enclosure leakage current, especially when the equipment is part of a network.
- Mechanical strength — X-ray tube housings and supporting structures must withstand forces due to handling and seismic events per CSA C22.2 No. 60601-1.
- Software-based control — If the equipment relies on programmable electronic systems (PES), the software must be validated following the risk management process outlined in ISO 14971 and referenced in the standard.
Harmonization Benefit: Since CSA C22.2 No. 60601-2-28-18 is aligned with IEC 60601-2-28, manufacturers using a CB scheme can often rely on test reports from IEC inspections, reducing duplication in Canadian certification.
Compliance and Certification
To legally sell diagnostic X-ray equipment in Canada, manufacturers must demonstrate compliance with CSA C22.2 No. 60601-2-28-18. This involves:
- Engaging a recognized certification body (e.g., CSA Group, Intertek, UL Canada).
- Submitting a technical file including risk management, test reports, and essential performance verification.
- Accepting facility audits if the product is a complete installation.
The standard also includes transitional provisions. As of 2026, any changes to referenced standards (like IEC 60601-1-2 for EMC) must be incorporated. Manufacturers should maintain active surveillance of amendments issued by CSA and SCC.
Non-compliance risk: Without CSA certification, hospitals may not be permitted to use the equipment, and Health Canada may refuse to issue a Medical Device Establishment Licence (MDEL) for the importer. Fines and product recalls are possible.
While CSA C22.2 No. 60601-2-28-18 is a comprehensive document, it does not cover every possible design. It is the manufacturer’s responsibility to perform a complete risk analysis and address any hazards not specifically mentioned in the standard. Always refer to the latest version of CSA C22.2 No. 60601-1 and consult with a qualified test lab.
Frequently Asked Questions
Q: Is CSA C22.2 No. 60601-2-28-18 mandatory in Canada?
A: Yes. It is a national standard of Canada and forms the basis for compliance with the Canadian Electrical Code and the Medical Devices Regulations. Most provincial authorities require that X-ray equipment sold or installed in Canada bears a certification mark confirming conformance to this standard.
A: Yes. It is a national standard of Canada and forms the basis for compliance with the Canadian Electrical Code and the Medical Devices Regulations. Most provincial authorities require that X-ray equipment sold or installed in Canada bears a certification mark confirming conformance to this standard.
Q: How does this standard differ from IEC 60601-2-28?
A: The technical content is identical to the international edition, but the CSA version includes Canadian deviations and clarifications, such as references to the CSA C22.1 (Canadian Electrical Code) and specific temperature testing conditions for Canadian climate. Annexes may also include notes for bilingual labelling.
A: The technical content is identical to the international edition, but the CSA version includes Canadian deviations and clarifications, such as references to the CSA C22.1 (Canadian Electrical Code) and specific temperature testing conditions for Canadian climate. Annexes may also include notes for bilingual labelling.
Q: Does this standard cover dental or veterinary X-ray equipment?
A: No. Dental equipment is covered by a separate application standard (IEC 60601-2-63 for dental extra-oral and IEC 60601-2-65 for intra-oral), while veterinary equipment is not included in the scope unless explicitly used on human patients. Manufacturers should check Health Canada guidance for such devices.
A: No. Dental equipment is covered by a separate application standard (IEC 60601-2-63 for dental extra-oral and IEC 60601-2-65 for intra-oral), while veterinary equipment is not included in the scope unless explicitly used on human patients. Manufacturers should check Health Canada guidance for such devices.
Q: What are the typical testing costs?
A: Costs vary widely based on the equipment type and number of configurations. A full evaluation by a third-party lab may range from $15,000 to $50,000 USD, with annual factory inspections adding several thousand dollars. These figures are estimates and should be verified directly with the certification body.
A: Costs vary widely based on the equipment type and number of configurations. A full evaluation by a third-party lab may range from $15,000 to $50,000 USD, with annual factory inspections adding several thousand dollars. These figures are estimates and should be verified directly with the certification body.
This article is intended for informational purposes only. For official compliance, always consult the current version of CSA C22.2 No. 60601-2-28-18 and your certification body. © 2026 Technical Standards Press.