Recognised & Mandatory Standards
Overview
Health Canada recognises international standards as a basis for demonstrating compliance with Schedule 1 Safety and Effectiveness Requirements. Meeting a recognised standard provides a presumption of compliance with the corresponding requirement.
Health Canada also designates certain standards as Mandatory Standards for specific device types. Manufacturers must attest to compliance with applicable Mandatory Standards in their Device Licence application.
Recognised standards
The following are frequently cited recognised standards:
Quality and risk management
| Standard | Scope |
|---|---|
| ISO 13485:2016 | Quality management systems for medical devices |
| ISO 14971:2019 | Risk management for medical devices |
Software and AI
| Standard | Scope |
|---|---|
| IEC 62304:2006+A1:2015 | Medical device software lifecycle processes |
| IEC 62366-1:2015+A1:2020 | Usability engineering |
Biological safety
| Standard | Scope |
|---|---|
| ISO 10993-1:2018 | Biological evaluation — risk management approach |
| ISO 10993-5:2009 | Tests for cytotoxicity |
| ISO 10993-10:2021 | Tests for skin sensitisation |
Electrical safety
| Standard | Scope |
|---|---|
| IEC 60601-1:2005+A1:2012+A2:2020 | General safety and essential performance |
| IEC 60601-1-2:2014+A1:2020 | EMC requirements |
| IEC 60601-1-6:2010+A1:2013+A2:2020 | Usability |
Sterilisation
| Standard | Scope |
|---|---|
| ISO 11135:2014 | Sterilisation by ethylene oxide |
| ISO 11137 series | Sterilisation by radiation |
| ISO 17665-1:2006 | Sterilisation by moist heat |
| ISO 11607 series | Packaging for terminally sterilised devices |
Mandatory Standards
Health Canada publishes a list of Mandatory Standards for specific device types. Compliance with applicable Mandatory Standards must be attested in the Device Licence application. The attestation confirms that:
- The standard applies to the device
- The device conforms to the current version of the standard
The current list of Mandatory Standards is published on the Health Canada website.
How to demonstrate compliance
Compliance with standards can be demonstrated by:
- Test reports from an accredited laboratory or internal testing
- Certificates of conformity from an accredited certification body
- Declaration of conformity signed by an authorised representative
- Technical documentation in the QMS demonstrating conformance
International standard recognition
Health Canada generally accepts standards published by:
- ISO (International Organization for Standardization)
- IEC (International Electrotechnical Commission)
- ASTM International
- Other bodies where formally recognised
When international standards are revised, Health Canada typically allows a transition period before requiring compliance with the new version.
Legislative source: Medical Devices Regulations, SOR/98-282, s 32(k) (attestation to standards)