Medical Electrical Equipment - Part 2-26: Particular Requirements for the Safety of Electroencephalographs (IEC 60601-2-26:2012, MOD)
医用电气设备.第2-26部分:脑电图仪安全的特殊要求(IEC 60601-2-26-2012 MOD)
This is the third edition of CAN/CSA-C22.2 No. 60601-2-26. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, with Canadian deviations).
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS (EEG) as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This Standard is applicable to ME EQUIPMENT used in a clinical environment (e.g., hospital, physician's office, etc.).This Standard does not cover requirements for other equipment used in electroencephalography such as: phono-photic stimulators electroencephalographic telemetry EEG data storage and retrieval ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy ambulatory electroencephalographic recorders.The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.63.