What are the requirements of the CE certification standards for medical electrical appliances:

①Circuit schematic diagram and PCB layout diagram.

②Product manual and product nameplate.

③Product working principle diagram and block diagram.

④ List of key components (wires, plugs, fuses, varistors, optocouplers, X/Y capacitors, transformers, housings, etc.) product BOM;

CE certification, 3C certification

⑤Product related specifications.

Medical electrical appliances EN60601 standard CE certification specific process:

① Submit product information, including usage, style pictures and related parameters for quotation.

②The certification body will send the relevant quotation to the customer. The quotation includes (project operation cycle, certificate sample, quantity, information to be submitted, etc.). ③The manufacturer mails samples and officially starts operation. Manufacturers need to cooperate with the submission of information. It depends on the specific project, many of which require factory inspections. The specific operation of certification is carried out in accordance with legal requirements.

④Confirm the certificate information and pay the balance to obtain the certificate. The CE certification cycle of medical devices The CE certification cycle depends on the test cycle of the product. Product certification usually takes 2-6 working weeks, and then the test cycle varies according to each product.