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CAN/CSA C22.2 No. 60601-2-3-14 (2018): Safety and Performance Requirements for Short-Wave Therapy Equipment
A comprehensive guide to the Canadian adoption of IEC 60601-2-3 for short-wave diathermy devices
Scope of CAN/CSA C22.2 No. 60601-2-3-14 (2018)
CAN/CSA C22.2 No. 60601-2-3-14 (2018) is the Canadian national adoption of the international standard IEC 60601-2-3:2012+AMD1:2016, with specific Canadian deviations and clarifications. This standard specifies particular requirements for the basic safety and essential performance of short-wave therapy equipment, commonly known as short-wave diathermy devices, used in physiotherapy, rehabilitation, and sports medicine.
The standard applies to:
- Short-wave therapy equipment operating in the frequency range 1 MHz to 300 MHz (primarily the ISM bands of 13.56 MHz, 27.12 MHz, and 40.68 MHz).
- Equipment intended for both professional healthcare facilities and home healthcare environments (with additional requirements).
- Stand-alone short-wave diathermy units as well as those integrated into multi-function therapy systems.
It excludes long-wave therapy equipment, microwave diathermy, and ultrasonic therapy devices, which are covered by other parts of the IEC 60601-2 series.
Important: In Canada, compliance with CAN/CSA C22.2 No. 60601-2-3-14 (2018) is required for marketing and installation of short-wave therapy equipment under provincial electrical safety regulations. The standard must be used together with CAN/CSA-C22.2 No. 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance), which forms the horizontal foundation.
Technical Requirements
Output Characteristics and Frequency Tolerance
The standard imposes strict limits on output power, frequency stability, and harmonic emissions to ensure safe and effective treatment while minimising electromagnetic interference (EMI).
| Parameter | Requirement | Test Method |
|---|---|---|
| Rated output frequency tolerance | ± 0.5% of nominal ISM frequency | Frequency counter measurement at applicator port |
| Maximum continuous output power | ≤ 400 W (continuous) / ≤ 1000 W (pulsed) | Power meter measurement in matched load |
| Harmonic emissions (above 1 MHz) | ≤ –50 dBc relative to carrier | Spectrum analyser per CISPR 11 |
| Leakage current (patient leads) | ≤ 10 µA (DC), ≤ 100 µA (AC) | Per IEC 60601-1 clause 8 |
| Applicator surface temperature | ≤ 41 °C at max power for 10 min | Thermocouple in contact with tissue-equivalent phantom |
Essential Performance Criteria
CAN/CSA C22.2 No. 60601-2-3-14 (2018) defines essential performance as the ability to deliver controlled RF energy without causing unintended burns or excessive temperature rise. The manufacturer must:
- Demonstrate accurate power delivery within ±20% of the set value over the full range of applicator sizes.
- Implement redundant output timers that automatically disable the RF output after a preset treatment duration (maximum 60 minutes).
- Provide means to detect and interrupt output in case of applicator cable fault or patient-electrode contact failure.
Design Tip: Many manufacturers incorporate a saline load test circuit to verify tissue contact before enabling RF power. This simplifies compliance with the single-fault condition tests required by the standard.
Implementation Highlights
Risk Management Integration
As a vertical particular standard, CAN/CSA C22.2 No. 60601-2-3-14 (2018) assumes the existence of a risk management process in accordance with ISO 14971. Specific hazards associated with short-wave therapy—such as burns due to uncontrolled energy deposition, interference with active implantable medical devices (e.g., pacemakers), and fire risk from conductive objects in the field—must be explicitly addressed in the risk management file.
Electromagnetic Compatibility (EMC)
The standard incorporates EMC requirements from IEC 60601-1-2 (adopted as CAN/CSA-C22.2 No. 60601-1-2) with additional emission limits for the therapy frequency bands. Equipment must not cause harmful interference to other medical devices in the same room, particularly electrocardiographs, electromyographs, and pulse oximeters.
Critical: Short-wave diathermy devices are classified as Group 2 (RF energy used for treatment) under CISPR 11 and must carry appropriate warning labels regarding potential interference with pacemakers and other electronic implants. The standard requires a minimum separation distance warning of 30 cm between the applicator and any bystander, and 1 m from life-support equipment.
Canadian-Specific Deviations
- Bilingual marking: All labels, warnings, and instructions must be in English and French. The standard specifies acceptable phrasing for phrases like “DANGER – HAUTE FRÉQUENCE” and “ATTENTION – PUISSANCE DE SORTIE”.
- Grounding integrity: Additional requirements for protective earth connections in portable equipment to comply with Canadian Electrical Code (CE Code, CSA C22.1).
- Service access: Requirements for key‑locked or tool‑accessible covers over high‑voltage RF components to prevent operator or patient contact during maintenance.
Compliance and Certification Notes
CSA Certification Marks
Manufacturers seeking to sell short-wave therapy equipment in Canada must obtain a CSA certification mark from the Canadian Standards Association (CSA Group) or an accredited certification body (e.g., Intertek, UL). The evaluation includes:
- Full technical review of the risk management file and essential performance documentation.
- Type testing of one representative unit at an accredited laboratory.
- Factory inspection for quality control and production consistency.
Key Documents for Compliance
| Document/Report | Required Content |
|---|---|
| Risk Management File (ISO 14971) | Hazard identification, risk control measures, residual risk acceptance |
| Essential Performance Report | Verification of power accuracy, timer accuracy, temperature limits |
| EMC Test Report (IEC 60601-1-2) | Emissions and immunity measurements per applicable limits |
| Electrical Safety Test Report | Leakage currents, dielectric strength, ground bond tests |
| Biocompatibility Evaluation | Skin contact materials for applicators and pads (ISO 10993-5 and -10) |
Compliance Cycle: CAN/CSA C22.2 No. 60601-2-3-14 (2018) was published in 2018 but incorporates the 2016 amendment to IEC 60601-2-3. Manufacturers should check with CSA for the latest edition and any upcoming revisions. The standard remains current as of 2026.
Products that are sold in Canada but manufactured outside the country require a CSA certificate of acceptance or a CB test certificate referencing CAN/CSA C22.2 No. 60601-2-3-14 (2018) together with the national differences. Successful certification enables the product to bear the CSA mark and be listed in the CSA product directory.
Q: What is the difference between CAN/CSA C22.2 No. 60601-2-3-14 (2018) and IEC 60601-2-3:2012?
A: The Canadian standard is technically equivalent to IEC 60601-2-3:2012, as amended in 2016, with additional national deviations. The deviations mainly concern bilingual labelling, grounding requirements per the Canadian Electrical Code, and specific test conditions for climatic conditions (temperature range of –20 °C to +50 °C for storage).
A: The Canadian standard is technically equivalent to IEC 60601-2-3:2012, as amended in 2016, with additional national deviations. The deviations mainly concern bilingual labelling, grounding requirements per the Canadian Electrical Code, and specific test conditions for climatic conditions (temperature range of –20 °C to +50 °C for storage).
Q: Does this standard apply to all types of short-wave therapy equipment?
A: It applies to equipment using capacitive or inductive applicators with a rated output frequency of 1–300 MHz. This includes continuous and pulsed short-wave diathermy (PSWD) units. Microwave diathermy (≥ 300 MHz) and ultrasonic therapy equipment are not covered and must comply with other standards (e.g., IEC 60601-2-6 or IEC 60601-2-5).
A: It applies to equipment using capacitive or inductive applicators with a rated output frequency of 1–300 MHz. This includes continuous and pulsed short-wave diathermy (PSWD) units. Microwave diathermy (≥ 300 MHz) and ultrasonic therapy equipment are not covered and must comply with other standards (e.g., IEC 60601-2-6 or IEC 60601-2-5).
Q: Can I use a CB test report to certify my product for Canada?
A: Yes. CSA Group is a member of the IECEE CB Scheme. A CB test certificate and report for IEC 60601-2-3:2012+A1:2016, together with a national differences report for Canada, can be used to obtain the CSA certification mark. However, the manufacturer must ensure that the differences (e.g., bilingual markings) are implemented in the product.
A: Yes. CSA Group is a member of the IECEE CB Scheme. A CB test certificate and report for IEC 60601-2-3:2012+A1:2016, together with a national differences report for Canada, can be used to obtain the CSA certification mark. However, the manufacturer must ensure that the differences (e.g., bilingual markings) are implemented in the product.
Q: Are there specific requirements for home-use short-wave therapy devices?
A: Yes. Clause 201.11 of the standard imposes stricter limits on output power (≤ 50 W for home use) and additional usability engineering requirements per IEC 60601-1-6. The standard also requires a lockout mechanism to prevent unsupervised use by untrained persons.
A: Yes. Clause 201.11 of the standard imposes stricter limits on output power (≤ 50 W for home use) and additional usability engineering requirements per IEC 60601-1-6. The standard also requires a lockout mechanism to prevent unsupervised use by untrained persons.
© 2026 – Technical Article on CAN/CSA C22.2 No. 60601-2-3-14 (2018). For informational purposes only. Always consult the official standard for compliance.