Medical Device Facts and Medical Mask Compliance (119-098)
Compliance of medical masks 119-098:
Consider that medical masks are classified as a Class I medical device in Canada. The masks comply with EN 14683 type IIR standards, this standard is admissible in Canada according to the recommendations of the Government of Canada. The masks are manufactured by a manufacturer holding an ISO 13485 quality control system and the masks are certified by Health Canada according to the legal provisions relating to imports and exceptional and sale provisions provided for in the Interim Order related to COVID-19 .
Regulatory authority for certification: Consider Health Canada as the only regulatory authority competent to certify a medical device in Canada.
Recognized standards for mask performance: Consider that only the Canadian Government can determine what standards are acceptable in Canada.
Authority for the use of masks in the workplace: Consider that the INSPQ only confirms the acceptable standards for workers in Quebec.
Instruments compliant with Health Canada requirements
The medical devices on the list are called "designated medical devices" in accordance with Health Canada requirements.
rEfErence Complete list
Standards recognized by the Canadian government
Specifications for COVID-19 products for single use medical masks.
REFERENCE Complete list
Standards applicable for masks by the INSPQ
Quality specification relating to the continuous wearing of medical masks in workplaces defined by the INSPQ.
REfErence INSPQ Website
Summary table of accepted standards
|
Authority / Role |
Government of Canada Définis les normes autorisées au pays |
Health Canada Confirms the approval of the product according to authorized standards |
INSPQ (*) Recommends the use of the product according to the work environment |
| Masks (119-098) | ✅ EN 14683 de type IIR |
✅ EN 14683 de type IIR |
✅ EN 14683 de type IIR |
(*) Applicable in Quebec.
If you have any questions regarding the conformity or the quality of our products, please do not hesitate to contact us.