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Navigating CSA C22.2 No. 60601-2-37-08 amd1-2019: Safety and Performance Standards for Ultrasonic Medical Diagnostic Equipment
A comprehensive overview of the scope, technical updates, and compliance requirements for the Canadian amendment
Scope and Application
CSA C22.2 No. 60601-2-37-08 amd1-2019 is a particular standard within the CSA C22.2 No. 60601 series, which harmonizes with the international IEC 60601 framework for medical electrical equipment. This amendment updates the earlier 2008 edition and aligns with IEC 60601-2-37:2007/AMD1:2015. The standard applies to the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment used in healthcare settings.
The scope covers devices that use ultrasound for diagnostic imaging, physiological monitoring, and measurements—such as B-mode, M-mode, Doppler, and elastography systems. It specifically excludes equipment intended for therapeutic ultrasonic applications. The standard addresses technical aspects including acoustic output limits, temperature rise, image quality, and electrical safety.
Key takeaway: Compliance with this amendment ensures that ultrasonic diagnostic equipment meets the latest Canadian safety and performance requirements, reducing patient and operator risk while enabling effective clinical use.
Key Technical Requirements and Updates
Acoustic Output and Patient Safety
The amendment introduces refined limits for acoustic output parameters, particularly focusing on the thermal index (TI) and mechanical index (MI). These indices are now required to be displayed in real-time during scanning, with stricter thresholds for equipment operating in obstetric or fetal applications. The maximum allowable surface temperature of the transducer has been clarified: under normal conditions, the temperature rise shall not exceed 10°C above ambient (maximum 43°C), and under single-fault conditions, the limit is 50°C.
Essential Performance
Essential performance requirements for ultrasonic diagnostic equipment have been updated to include minimum image quality criteria (e.g., spatial resolution, contrast resolution, depth of penetration) and measurement accuracy (e.g., distance, velocity, and volume measurements). The amendment also mandates that manufacturers define and validate essential performance characteristics in accompanying documents and risk management files.
Electrical Safety and Environmental Considerations
Electrical safety provisions follow the general requirements of CSA C22.2 No. 60601-1 but with specific modifications for ultrasound systems. The amendment clarifies leakage current limits for patient-applied parts, dielectric strength testing, and protective earth continuity. Environmental testing now includes more rigorous conditions for transport and storage, referencing CSA C22.2 No. 60601-1-8 for alarm systems and CSA C22.2 No. 60601-1-11 for home healthcare environments.
Labelling and Documentation
Significant changes in Amendment 1 relate to labelling. The standard now requires:
– Clear display of the thermal index (TI) and mechanical index (MI) on the monitor during active scanning.
– External marking indicating the maximum acoustic output levels.
– Updated instructions for use (IFU) that include warnings about potential bioeffects, especially in prolonged examinations.
– Requirements for medical electrical equipment symbols per IEC 60417.
| Parameter | Requirement / Limit | Test / Verification |
|---|---|---|
| Maximum surface temperature (normal condition) | ≤ 10°C rise (ambient 33°C), max 43°C | Thermocouple measurement over 4 hours |
| Maximum surface temperature (single fault) | ≤ 50°C | Thermocouple measurement with fault applied |
| Thermal Index (TI) soft tissue | Display required; TIS ≤ 6.0 for abdominal | Real-time display vs. threshold |
| Mechanical Index (MI) | Display required; MI ≤ 1.9 (general), ≤ 0.7 for ophthalmic | Derated pressure measurement |
| Leakage current (patient-applied part) | ≤ 10 µA under normal condition, ≤ 50 µA under single fault | As per CSA C22.2 No. 60601-1 |
| Dielectric strength (mains parts to patient) | 1500 V AC / 2500 V DC, 1 minute | High-voltage test |
Note: The Canadian amendment may include deviations from the IEC base standard. Manufacturers should always consult the current CSA edition and confirm with their certification body (e.g., CSA Group) regarding any specific Canadian requirements.
Compliance and Certification Considerations
Manufacturers seeking certification to CSA C22.2 No. 60601-2-37-08 amd1-2019 must follow a structured process. The standard references ISO 14971:2007 (Medical devices – Application of risk management) for identifying hazards associated with ultrasonic exposure. A risk management file must demonstrate that all residual risks are minimized and acceptable. Key steps include:
- Determination of essential performance: Identify the performance characteristics critical for safety and declare them in the technical documentation.
- Acoustic output testing: Perform measurements in accordance with IEC 62359 (ultrasonic field measurement) to verify TI and MI compliance.
- Thermal testing: Ensure transducer surface temperature stays within limits under worst-case conditions.
- Electrical safety testing: Conduct leakage current, dielectric strength, and grounding tests per the general standard.
- Labelling and IFU review: Ensure all required markings, symbols, and warnings are present and written in both English and French for the Canadian market.
Certification is performed by recognized bodies such as CSA Group, Intertek, UL, or TÜV SÜD. The amendment does not introduce a mandatory transition date, but it is strongly recommended that new designs comply with the latest version to avoid market barriers.
Compliance tip: When updating a legacy system to meet the amendment, pay special attention to the real-time display of acoustic indices—this often requires software and hardware changes. Also ensure that the risk management file reflects the updated output limits.
Common pitfall: Failing to consider the different limits for specialized applications (e.g., ophthalmic vs. general imaging) can lead to noncompliance. Always verify the intended use environment and patient population.
Frequently Asked Questions
Q: What is the difference between CSA C22.2 No. 60601-2-37-08 amd1-2019 and the IEC standard IEC 60601-2-37:2007/AMD1:2015?
A: The CSA standard is the Canadian national adoption of the IEC document. While technically identical in most aspects, it includes deviations to address Canadian regulatory requirements (e.g., bilingual labeling, reference to the Canadian Electrical Code Part I). It also includes specific national testing conditions and modifications to some clauses to reflect Canadian medical device regulations (SOR/98-282).
A: The CSA standard is the Canadian national adoption of the IEC document. While technically identical in most aspects, it includes deviations to address Canadian regulatory requirements (e.g., bilingual labeling, reference to the Canadian Electrical Code Part I). It also includes specific national testing conditions and modifications to some clauses to reflect Canadian medical device regulations (SOR/98-282).
Q: Does the amendment apply only to new equipment, or also to existing systems?
A: The amendment is applicable to new models or significant modifications. Existing equipment certified to the previous edition (2008) may continue to be sold and serviced without retrofitting, but any changes affecting safety or essential performance require re‑evaluation under the amended standard. It is recommended to always use the latest version to ensure market acceptance.
A: The amendment is applicable to new models or significant modifications. Existing equipment certified to the previous edition (2008) may continue to be sold and serviced without retrofitting, but any changes affecting safety or essential performance require re‑evaluation under the amended standard. It is recommended to always use the latest version to ensure market acceptance.
Q: Are there specific requirements for ultrasound equipment used in home healthcare?
A: Yes, the amendment includes a reference to CSA C22.2 No. 60601-1-11, which specifies requirements for medical electrical equipment intended for use in home healthcare environments. For ultrasound devices marketed for home use, additional requirements for mechanical strength, IPX ingress protection, and reliability of alarms may apply.
A: Yes, the amendment includes a reference to CSA C22.2 No. 60601-1-11, which specifies requirements for medical electrical equipment intended for use in home healthcare environments. For ultrasound devices marketed for home use, additional requirements for mechanical strength, IPX ingress protection, and reliability of alarms may apply.
Q: What are the consequences of non‑compliance with this standard?
A: In Canada, medical electrical equipment must comply with the applicable CSA standards to be eligible for sale and installation. Non‑compliance can lead to rejection during certification, mandatory recall, and penalties under the Canadian Medical Devices Regulations. It also increases liability risk in case of patient injury.
A: In Canada, medical electrical equipment must comply with the applicable CSA standards to be eligible for sale and installation. Non‑compliance can lead to rejection during certification, mandatory recall, and penalties under the Canadian Medical Devices Regulations. It also increases liability risk in case of patient injury.
This article is based on information available as of 2026. For the most current version, always consult the official CSA publication or contact an accredited testing laboratory.