According to the EU classification of products belonging to the Gamma Knife Ⅱb class with CE certification process and reads as follows: (1) enterprise application for certification to the certification body and fill certification RFQ cross certification bodies; (2) to apply for certification bodies certified company raised quotations, corporate signature confirmation to complete the contract; (3) companies to submit ISO9000 + ISO13485 quality system documentation that the quality manual and program files to the certification body for document review system certification bodies; former quality system audit, corporate due at least three months of the quality system running records, and completed an internal quality audit system 1-2 times. (4) certified product testing certification issued notice to the certification body accredited laboratory, the laboratory will have to apply for certification of products for low voltage (LVD) testing and electromagnetic compatibility (EMC) testing. If there failed the test, re-test after the change under the enterprise until tested so far. End of the test, the test report issued by the laboratory. (5) the preparation of technical documents archives enterprise certified products (the TCF file). As one of the above test report also TCF file contents. TCF file is an important application for CE certification documents submitted by the manufacturer to the CE certification, which is an important basis for the certification body audits for certification. TCF preparation of all documents must be in English.