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IECEE - certification

Johan Olson 353 views 2019-09-19 08:22:44

Anyone that knows were I can find a company that can do a IECEE certification on a medical device ASAP? Please advise! Best regards johan Olson, consultant and SME coach for EU
Answer by Johan Olson 2019-09-19 09:29:33

I am in need of the following; CB Certification/CB scheme for BERA unit with Battery Included should be atleast: IEC 60601-1 IEC 60601-1-2 - EMC IEC 60601-1-6 IEC 60601-2-40 – Evoked response – ME equipment Description of product You wish obtain the CB certifcation on your medical device : BERA The device is a medical device intended for collecting brain wave throughout electrodes and cables, when patients listen to specific sounds. The device is composed of device (with battery) and a laptop. The equipment is Class I, Type BF, and intended for continous operation.