CSA SPE-3000:19 Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES).
18.104.22.168 . For MEE or MES parts that contact the patient, the evaluation shall include an evaluation of whether parts that can come into contact with the patient but fall outside of the definition of applied parts shall be subject to the requirements for applied parts. If the evaluation determines that such parts are subject to the requirements for applied parts, then all the relevant requirements and tests of this Model Code shall apply. 22.214.171.124 Electrical equipment using materials or having forms of construction differing from those detailed in a particular Canadian Electrical Code, Part I, standard may be considered to comply with the requirements of that standard provided that the intent of the standard requirement has been met (see Annex A). 126.96.36.199 Electrical component parts in MEE or MES shall be of types specifically approved for the use intended or shall be evaluated with, and as an integral part of, the equipment. 188.8.131.52 Equipment used under special installation conditions can require additional evaluation. 184.108.40.206 If MEE is specified for connection to a separate power source other than the supply mains, either the separate power source shall be considered part of the MEE, and all relevant requirements of this Model Code shall apply, or the combination shall be considered an MES. 220.127.116.11 If MEE is specified for power supplied from an external dc power source, no hazardous situation shall develop when a connection with the wrong polarity is made. The MEE, when connection is subsequently made with the correct polarity, shall provide freedom from hazard. Protective devices that can be reset by anyone without the use of a tool are acceptable provided that these restore correct operation on reset. Note: The external dc power source can be a supply mains or other power source. In the latter case, the combination is considered to be an MES.CSA SPE-3000 pdf download.