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Understanding CSA C22.2 No. 26-13 (2018): Medical Electrical Equipment Safety Requirements
Comprehensive Guide to the Canadian Standard for Basic Safety and Essential Performance of Medical Electrical Equipment
Scope and Application
CSA C22.2 No. 26-13 (2018) is the Canadian adoption of IEC 60601-1:2005+AMD1:2012, establishing general requirements for the basic safety and essential performance of medical electrical (ME) equipment and ME systems. This standard applies to the design, manufacture, and testing of all ME equipment intended for diagnosis, treatment, monitoring, or direct patient care under normal and single-fault conditions.
The standard replaces earlier Canadian editions (e.g., No. 26-08, C22.2 No. 601.1-M90) and is referenced by Health Canada as a recognized standard for demonstrating conformity to the Medical Devices Regulations (SOR/98-282). It is harmonized with the international 3.1 edition of IEC 60601-1, including Canadian deviations for national differences in supply voltage, wiring colors, and language requirements for markings and accompanying documents.
Exclusions include in vitro diagnostic equipment (covered by IEC 61010 series), equipment for veterinary use, and non‑medical electrical appliances (e.g., office furniture, building infrastructure). The standard also does not cover functional safety of programmable systems (dealt with in IEC 62304) unless specifically required within the collateral or particular standards.
Compliance Benefit: Adherence to CSA C22.2 No. 26-13 (2018) simplifies market access in Canada, reduces liability risks, and aligns with global 60601-1 requirements, facilitating international submissions when national deviations are managed properly.
Technical Requirements
General Requirements
The standard mandates a risk management process (aligned with ISO 14971) to identify hazards, estimate and evaluate risks, and implement control measures. Essential performance—performance necessary to achieve freedom from unacceptable risk—must be defined and verified.
Classification
ME equipment is classified according to:
- Type of protection against electric shock (Class I, Class II, internally powered)
- Degree of protection against electric shock (type B, BF, CF applied parts)
- Degree of protection against harmful ingress of water or particulate matter (IP code)
- Mode of operation (continuous, short-time, intermittent)
- Sterilization method or cleaning/disinfection requirements
Key Technical Requirements and Tests
| Requirement / Test | Clause(s) | Description |
|---|---|---|
| Protection against electric shock | 7–8 | Leakage current limits (earth, enclosure, patient) under normal and single-fault conditions; dielectric strength; protective earth impedance. |
| Mechanical strength | 9, 11 | Resistance to impact, vibration, and moving parts; stability against tipping; anti‑trapping safeguards. |
| Excessive temperatures | 10 | Temperature rise limits for components and accessible surfaces; protection against fire hazard. |
| Radiation protection | 12 | Limits for ionizing, optical, acoustic, and electromagnetic radiation (collateral standards apply for specific modalities). |
| Marking and documents | 6 | Mandatory markings on equipment (e.g., manufacturer, model, electrical rating, applied part symbol) and accompanying documents in English and French. |
Implementation Tip: When designing for the Canadian market, incorporate bilingual (English/French) marking early in development, and account for nominal voltage of 120 V / 240 V / 347 V as per Canadian Electrical Code Part I (C22.1) when selecting components.
Essential Performance and Risk Control
The manufacturer must specify essential performance criteria for each function that could affect clinical safety. Risk control measures (e.g., redundant monitoring, alarms, protective features) shall be validated by testing under normal and single-fault conditions. The standard also requires that reasonably foreseeable misuse be considered during risk analysis.
Implementation Highlights
Adopting CSA C22.2 No. 26-13 (2018) involves more than simply applying test limits; it demands a systematic risk management approach integrated into the entire product lifecycle. Key implementation steps include:
- Risk Management File: Conduct an up‑to‑date hazard analysis per ISO 14971, document risk control measures, and verify residual risks are acceptable.
- Test Planning: Use the standard’s test sequence (clause 5) and prepare for type tests (complete safety tests on a representative sample) and production tests (routine dielectric strength and ground bond tests).
- Compliance Documentation: Assemble a technical file including design dossiers, test reports, risk management reports, and declarations of conformity.
- Certification: Engage a recognized certification body (e.g., CSA Group, Intertek, UL) to conduct evaluation and issue a certificate of compliance for the Canadian market.
Caution: CSA C22.2 No. 26-13 (2018) includes Canadian national differences that may not be present in other national adoptions of IEC 60601-1. Pay close attention to Annexes D and E of the standard regarding supply connection, neutral polarity, and marking language. Non‑compliance with these deviations can result in certification failures.
Compliance and Certification Notes
Compliance with CSA C22.2 No. 26-13 (2018) is voluntary in Canada; however, it is considered a de facto requirement for obtaining a Medical Device Establishment Licence (MDEL) or Health Canada device licence for Class II, III, and IV devices. The Standard Council of Canada (SCC) accredits certification bodies that may issue a CSA mark or equivalent certification.
Manufacturers should also note that this standard is often supplemented by collateral standards (e.g., CSA C22.2 No. 60601-1-2 for EMC) and particular standards for specific devices (e.g., ventilators, infusion pumps). Using a compliance matrix that maps requirements to test reports facilitates audits and proof of conformity.
Critical: Failure to meet essential performance or leakage current limits can lead to immediate product rejection during certification testing. For mains‑operated equipment, ensure protective earth impedance is less than 0.1 Ω (for 10 A rated supply) and that patient leakage current under normal condition does not exceed 10 µA for CF‑type applied parts.
Keeping abreast of amendments and new editions is essential. While the 2018 edition remains current, manufacturers should monitor the upcoming CSA C22.2 No. 60601‑1 series, which may incorporate changes from IEC 60601‑1 edition 3.2 (AMD2:2020).
Frequently Asked Questions
Q: Does CSA C22.2 No. 26-13 (2018) apply to software used in medical devices?
A: Yes, to the extent that the software is an integral part of the ME equipment or ME system. The standard does not replace IEC 62304 for software lifecycle processes but requires that software risk control measures are validated for safety and essential performance. Software as a medical device (SaMD) not installed on a physical medical device is not covered by this standard; instead, IEC 62304 and collateral standards apply.
A: Yes, to the extent that the software is an integral part of the ME equipment or ME system. The standard does not replace IEC 62304 for software lifecycle processes but requires that software risk control measures are validated for safety and essential performance. Software as a medical device (SaMD) not installed on a physical medical device is not covered by this standard; instead, IEC 62304 and collateral standards apply.
Q: How does this Canadian standard differ from the international IEC 60601-1:2005+AMD1:2012?
A: CSA C22.2 No. 26-13 (2018) is technically identical but includes several national differences: (a) the supply voltage range is adapted to Canadian nominal voltages (120/240 V, 347 V); (b) markings and accompanying documents must be in English and French; (c) wiring color codes follow the Canadian Electrical Code (e.g., green or green/yellow for ground, white or grey for neutral); (d) certain alternative methods for temperature and leakage current testing are provided where Canadian conditions differ.
A: CSA C22.2 No. 26-13 (2018) is technically identical but includes several national differences: (a) the supply voltage range is adapted to Canadian nominal voltages (120/240 V, 347 V); (b) markings and accompanying documents must be in English and French; (c) wiring color codes follow the Canadian Electrical Code (e.g., green or green/yellow for ground, white or grey for neutral); (d) certain alternative methods for temperature and leakage current testing are provided where Canadian conditions differ.
Q: Is compliance with this standard mandatory for medical device certification in Canada?
A: Although not law, Health Canada recognizes CSA C22.2 No. 26-13 (2018) as an acceptable standard for demonstrating conformity to the Medical Devices Regulations (SOR/98-282). Most certification bodies require compliance to this standard as a prerequisite for issuing a Canadian safety certification mark. In practice, it is virtually mandatory for any medical electrical device marketed in Canada.
A: Although not law, Health Canada recognizes CSA C22.2 No. 26-13 (2018) as an acceptable standard for demonstrating conformity to the Medical Devices Regulations (SOR/98-282). Most certification bodies require compliance to this standard as a prerequisite for issuing a Canadian safety certification mark. In practice, it is virtually mandatory for any medical electrical device marketed in Canada.
Q: Can a manufacturer use test reports from a CB scheme to demonstrate compliance?
A: Yes, if the CB test report is based on IEC 60601-1:2005+AMD1:2012 and includes the Canadian national deviations, many certification bodies accept it with a supplementary review. However, if the original report does not cover the differences, additional testing or documentation may be necessary to fully demonstrate equivalence to CSA C22.2 No. 26-13 (2018).
A: Yes, if the CB test report is based on IEC 60601-1:2005+AMD1:2012 and includes the Canadian national deviations, many certification bodies accept it with a supplementary review. However, if the original report does not cover the differences, additional testing or documentation may be necessary to fully demonstrate equivalence to CSA C22.2 No. 26-13 (2018).
Published for reference as of 2026.