Interim Certification Requirements for MEDICAL ELECTRICAL ROBOT EQUIPMENT OR MEDICAL ELECTRICAL ROBOT SYSTEM
This Technical Information Letter (TIL) has been prepared to serve as an immediate certification document until the Medical Electrical Robots Equipment and Medical electrical Robots System particular standards (IEC 60601-2-XX) that will be published.
These interim requirements have been developed to provide technical guidance, and address the safety and performance requirements of medical robot equipment/system.
The CSA TIL is limited to the following types of medical robots as per IEC upcoming safety standards:
1. IEC 80601-2-77: Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of medical robots for surgery, and
2. IEC 80601-2-78: Medical Electrical Equipment - Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability.