Date Published: April 1, 2020
Recognizing that organizations may seek to produce 3D printed personal protective equipment (PPE) for healthcare workers, Health Canada has described the necessary standards, test laboratories for product testing, and regulatory authorization pathways. They specifically outline standards for Class I PPE which include face shields and face masks. Lastly, the document addresses urgent manufacturing scenarios, in which improvised production of face shields may occur if supplies dwindle and access becomes limited. Nevertheless, the government has outlined a set of minimum basic requirements and verification that will need to be incorporated. This document again specifically speaks to only Class I PPE, however, the government recognizes that need may arise for 3D printed Class II PPE in the future.
Summary by: Mark Youssef