CAN/CSA-C22.2 No.601.1.1-94

This standard aplies to the safety of MEDICAL ELECTRICAL SYSTEMS. It describes the safety requirements for MEDICAL ELECTRICAL SYSTEMS to provide protection for the PATIENT, the OPERATOR and surroundings. It is presumed that the party assembling or modifying the MEDICAL ELECTRICAL SYSTEMS will take the necessary steps to assure compliance with this standard. MEDICAL ELECTRICAL SYSTEMS shall be designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part 1. The requirements of this Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No.601.1, Medical electrical equipment, Part 1: General requirements for safety, and its supplement CAN/CSA-C22.2 No.601.1S1 (adopted amendment 1 to IEC 601-1) hereinafter referred to as the General Standard. For the purpose of testing and approving MEDICAL ELECTRICAL SYSTEMS covered within the scope of this Standard, the MEDICAL ELECTRICAL SYSTEM msut meet the combined requirements as applicable, of both this Standard and the General Standard.