Electrical Certification and Medical Devices
In addition to the electrical certification, all medical devices intended for use on humans must be licensed by Health Canada. A piece of equipment is considered a medical device it is represented as a diagnostic tool by its manufacturer and it is intended to be used on human beings. It is important to note that licensing as a medical device does not necessarily include CSA electrical certification. To determine whether a medical device is licensed for use in Canada, please refer to the Health Canada webpage. A searchable database of all licensed medical devices is provided.
If a medical device is not licensed for use in Canada and a P.I. wishes to use it in their research, they will need to send a letter to EHRS and include the following information:
- The name and manufacturer of each piece of equipment;
- A description of each piece of equipment (i.e., what it will be used for);
- Whether the P.I. has previous experience using this equipment;
- Whether each piece of equipment has an approved electrical certification mark;
- A list of medical device safety certifications;
- If available, a list of studies in which the equipment was used in similar experiments.
The letter must acknowledge that the equipment is not licensed for use in Canada and that all study participants will be advised of this. Also, it should state that the P.I. is satisfied that the equipment can be used safely in the laboratory on study participants.
This letter must be signed by the P.I., the Director or Chair of their Department or School, and the Dean of their Faculty. The Environmental Health and Research Safety Department will then send a letter of confirmation to the Director of Research Ethics which states that the P.I. has gone through the process for ensuring that electrical equipment, including medical devices, has the necessary electrical certifications and that safety considerations have been addressed.
If a piece of equipment is labelled by the manufacturer as NOT being a medical device and there is documentation to that effect, the equipment is acceptable for research use on humans at SFU as long as the appropriate electrical certification is in place.
In accordance with the BC Electrical Safety Regulation (2004), all electrical equipment, including medical devices, must contain a certification mark as indicated by the British Columbia Safety Authority. To determine whether a piece of equipment has an approved certification mark, please refer to the BC Safety Authority webpage
If a piece of equipment does not have an approved certification mark, Intertek Testing Services, located in Coquitlam, can certify the equipment for a fee. Intertek's phone number is 604-520-3321.
Please note that battery operated equipment does not require electrical certification. However, the associated battery charger must contain a BC Safety Authority approved certification mark.