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CAN/CSA C22.2 No. 60601-2-36-16: Technical Requirements for Lithotriptor Safety and Performance
A Comprehensive Guide to the Canadian Adoption of IEC 60601-2-36 for Extracorporeal Shock Wave Lithotripsy Equipment
CAN/CSA C22.2 No. 60601-2-36-16 is the Canadian national adoption of IEC 60601-2-36:2014 (including Amendment 1:2016) and specifies particular requirements for the basic safety and essential performance of equipment used for extracorporeally induced lithotripsy. As part of the CSA C22.2 series under the Canadian Electrical Code, this standard harmonizes Canadian regulations with international benchmarks, providing manufacturers and healthcare facilities with a unified framework for designing, testing, and certifying lithotriptors. This article examines the scope, key technical requirements, implementation strategies, and compliance pathways defined by this important standard.
Scope and General Requirements
CAN/CSA C22.2 No. 60601-2-36-16 applies to lithotriptors used for the noninvasive fragmentation of renal, ureteral, biliary, and other calculi via extracorporeal shock wave therapy. The standard covers equipment intended for both clinical and research settings but excludes devices designed purely for in vitro use or for other shock wave applications such as orthopedics or physiotherapy. It also excludes shock wave generators that are part of combination therapy systems unless the entire system is designated as a lithotriptor.
The standard supplements the general requirements of IEC 60601-1 (medical electrical equipment) and its collateral standards such as IEC 60601-1-2 (EMC) and IEC 60601-1-6 (usability). Manufacturers must demonstrate compliance with the base standard as well as the particular clauses of Part 2-36. In Canada, compliance with CAN/CSA C22.2 No. 60601-2-36-16 is recognized by regulatory bodies such as Health Canada as a route to demonstrating conformity to the Medical Devices Regulations (SOR/98-282).
Tip: Always verify the latest edition of CSA C22.2 No. 60601-2-36, as the 2016 edition includes Amendment 1, which clarifies requirements for electromagnetic compatibility (EMC) and adds provisions for remote control of shock wave delivery.
Key Scope Clarifications
- General safety: All hazards associated with electrical, mechanical, thermal, and radiation risks as per IEC 60601-1.
- Essential performance: Accurate generation and delivery of shock wave energy to the target region while minimizing damage to surrounding tissue.
- Classification: Typically Class II (Canada) or Class IIb (EU) under medical device classification rules.
Technical Requirements and Essential Performance
The standard defines quantitative and qualitative limits for shock wave parameters, focusing accuracy, and imaging integration. Table 1 summarizes the critical technical metrics that manufacturers must characterize and control.
| Parameter | Requirement / Limit | Clause Reference |
|---|---|---|
| Peak positive pressure (p+) | Specified range by manufacturer, typically 30–120 MPa at focus | 201.12.1.101 |
| Focal zone dimensions (−6 dB) | Measurable; typically ≤ 20 mm in length, ≤ 10 mm in width | 201.12.1.102 |
| Energy per pulse | Manufacturer tolerance ±20% of nominal value | 201.12.1.103 |
| Pulse repetition rate | Maximum cap based on thermal and tissue safety; typical ≤ 120 Hz | 201.12.1.104 |
| Focusing accuracy | Deviation ≤ 5 mm from intended target (if image-guided) | 201.12.4.101 |
| Imaging integration latency | ≤ 500 ms for real-time guidance systems | 201.12.4.102 |
| Maximum acoustic output | Must not exceed mechanical index (MI) limits defined by collaterals | 201.12.1.105 |
Shock Wave Generation and Control
Whether using electrohydraulic, electromagnetic, or piezoelectric generators, the equipment must reliably produce shock wave pulses with defined energy and focus. The standard mandates that the device shall not inadvertently deliver shock waves outside the intended region, i.e., when the coupling medium is insufficient or the focus is misaligned. An automatic shut-off or alarm is required if the focal zone shifts beyond permissible limits.
Protection Against Unintended Tissue Damage
Lithotripsy inherently risks trauma to renal parenchyma, skin, and adjacent organs. Clause 201.11 addresses protective measures including:
- Limitation of pulse repetition rate to avoid overheating
- Skin contact/coupling verification before shock wave emission
- Integration with respiratory gating to account for abdominal movement
- Emergency stop that de-energizes all shock wave generation within 3 s
WARNING: Inadequate coupling verification can lead to cavitation injuries at the shock wave entry point. The standard requires an automatic or manual test that interrupts delivery if coupling impedance exceeds 1.5 times the nominal value.
Imaging and Guidance
Most modern lithotriptors incorporate ultrasound, fluoroscopy, or both for targeting. The standard requires that the imaging system and shock wave generator share a common coordinate system with verified registration accuracy. If the imaging system fails, the lithotriptor must not allow therapy delivery.
Implementation and Testing Considerations
Successful compliance requires a thorough application of risk management per ISO 14971. Manufacturers must identify hazards related to shock wave targeting errors, overheating, and unintended firing. Verification and validation plans should include:
- Measurement of focal pressure distribution using hydrophone scanning (per IEC 61828)
- Accuracy tests under simulated respiratory motion
- Software verification (per IEC 62304) for any control algorithms
Test Methods
The standard references several test setups. For example, the focal zone size is determined by scanning a needle hydrophone in three axes and recording the −6 dB contour. A water tank with degassed, deionized water is typical. The standard specifies tolerances for the test environment, including temperature (22±3 °C) and dissolved gas content (< 5 ppm).
Good Practice: Engage an accredited testing laboratory early in development. Pre-compliance testing can reduce the risk of nonconformities during final certification. CSA marks are accepted by Health Canada, thus streamlining regulatory submissions.
Compliance and Certification in Canada
CAN/CSA C22.2 No. 60601-2-36-16 is recognized as a safety standard for medical electrical equipment under the Canadian Electrical Code, Part 2. To obtain CSA certification, the manufacturer typically:
- Engages a CSA Group accredited testing laboratory.
- Submits a compliance dossier including a risk management file, essential performance data, and test reports.
- Undergoes factory inspection and quality system audit (often to ISO 13485).
While the standard is nearly identical to the IEC source, Canadian requirements may include additional national differences (e.g., for supply voltage, ambient conditions). The official CSA edition incorporates Amendment 1 from IEC 2016, which updated requirements for EMC and introduced new definitions for single-fault conditions. For devices distributed globally, the CB Scheme certification using IEC 60601-2-36 can expedite acceptance in Canada if the National Differences are covered.
Differences from IEC 60601-2-36:2014+AMD1:2016
The CSA edition is technically equivalent to the IEC edition but includes:
- Reference to Canada-specific wiring and grounding (C22.1)
- Language requirements for labeling and accompanying documents (English and French)
- Minor deviations for local voltage and frequency (120 V / 60 Hz)
Important: CSA certification is not automatically reciprocal with UL or IEC CB reports. Be sure to request the CSA variant from your certification body if you need to market the product in Canada.
Frequently Asked Questions
Q: Does CAN/CSA C22.2 No. 60601-2-36-16 apply to devices that incorporate lithotripsy as part of a larger surgical system?
A: Yes, if the system includes an extracorporeal lithotripsy function. However, the standard applies only to the lithotripsy subsystem. Other functions (e.g., a surgical ablation module) must meet their own applicable Part 2 standards. The overall system must still comply with IEC 60601-1 and relevant collaterals.
A: Yes, if the system includes an extracorporeal lithotripsy function. However, the standard applies only to the lithotripsy subsystem. Other functions (e.g., a surgical ablation module) must meet their own applicable Part 2 standards. The overall system must still comply with IEC 60601-1 and relevant collaterals.
Q: Is the CSA mark mandatory for lithotriptors sold in Canada?
A: While Health Canada does not explicitly require a CSA mark, the Canadian Electrical Code mandates that electrical medical equipment be certified to a recognized safety standard. CSA certification is widely accepted as proof of compliance. In practice, most provincial electrical inspectors and buyers (hospitals) require CSA or equivalent accreditation (e.g., cUL, cETL).
A: While Health Canada does not explicitly require a CSA mark, the Canadian Electrical Code mandates that electrical medical equipment be certified to a recognized safety standard. CSA certification is widely accepted as proof of compliance. In practice, most provincial electrical inspectors and buyers (hospitals) require CSA or equivalent accreditation (e.g., cUL, cETL).
Q: How often is this standard updated?
A: CSA harmonizes changes from IEC. The current edition (2016) is under review; any new edition of IEC 60601-2-36 will likely be adopted by CSA within 2–3 years. Users should check the CSA website for the latest version.
A: CSA harmonizes changes from IEC. The current edition (2016) is under review; any new edition of IEC 60601-2-36 will likely be adopted by CSA within 2–3 years. Users should check the CSA website for the latest version.
Q: Can a manufacturer use a single test report for IEC and CSA certification?
A: Yes, most CB test reports can be upgraded to include the Canadian national differences. The manufacturer must provide evidence of meeting the specific deviations (e.g., bilingual labeling). Many accredited labs offer combined testing for IEC + CSA to minimize duplication.
A: Yes, most CB test reports can be upgraded to include the Canadian national differences. The manufacturer must provide evidence of meeting the specific deviations (e.g., bilingual labeling). Many accredited labs offer combined testing for IEC + CSA to minimize duplication.
© 2026 – This article provides general guidance and does not supersede the official text of CAN/CSA C22.2 No. 60601-2-36-16 or any regulatory requirements.