Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Appendix B, checklist for interim order submission

Find information on the requirements for getting medical devices authorized in Canada on the medical devices page.

# Item Check
1 engineering drawings N/A
2 materials specifications N/A
3 intended use N/A
4 biocompatibility test results N/A
5 particulate filter efficiency N/A
6 airflow resistance N/A
7 fit testing N/A
8 mechanical headstrap strength testing N/A
9 elastomeric respirator-specific PFE and breathability testing (if applicable) N/A
10 cleaning and disinfection (if applicable) N/A
11 filter reuse conditions (if applicable) N/A
12 flammability (if applicable) N/A
13 fluid resistance (if applicable) N/A
14 other testing (if applicable) for any additional labelling claims N/A
15 shelf life/expiration date validation and/or plan N/A
16 mask labelling representation (as directed in tables 3 and 4) N/A
17 packaging labelling (all information to be marked on packages or provided to the user) N/A
18 quality management arrangements: manufacturing process flow chart N/A
19 manufacturing process outline N/A
20 sampling plan and acceptance criteria N/A
21 quality control records plan N/A

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