Medical instrument products how to pass the CE certification

Products have passed CE certification, need to do a good job in three areas. One, collect and certification of products related to the EU technical regulations and standards of European Union (EN ), through digestion, absorption, incorporation of enterprise product standards. Second, enterprises in strict accordance with the above product standards organization of production, but also is the technical regulations and the requirements of EN standard, carry out to the enterprise product design development and manufacturing process. Third, enterprises must be in accordance with the ISO9000+ISO13485 standard to build and maintain the quality system, and obtained ISO9000+ISO13485 certification.
Medical hanging tower CE certification should follow the EU technical regulations and standards of EN
For the EU has released 18 industrial products, from the command structure, they can be divided into vertical and horizontal instruction instruction. Vertical instruction is a specific product as object, such as a medical device directive; level instruction applies to all kinds of products, such as electromagnetic compatibility, it is applicable to all electrical and electronic parts and components products.
For medical hanging tower, applied to the instruction of fourteenth, the first and fifth, namely: 93 / 42 / EEC Medical Devices Directive, 2006 / 95EEC low voltage ( LVD ) instruction and a 2004 / 108 / EEC electromagnetic compatibility ( EMC ) instruction. In support of these instructions to EU standards are: ( 1 ) EN60601-1 medical electrical equipment Part 1: General requirements for safety; ( 2) the EN60601-1-1 medical electrical equipment Part 1: General requirements for safety and the first amendment; ( 3) the EN60601-2-11 medical electrical equipment - Part second: ( 4) EN60601-1-2 medical electrical equipment part 1: General requirements for safety 1.2 Festival -- Collateral standard: electromagnetic compatibility - Requirements and tests. The article ( 1), ( 2), ( 3) standard is the medical hanging tower low voltage ( LVD ) test basis: article ( 4 ) standard is the medical hanging tower electromagnetic compatibility ( EMC ) testing based on.
Medical hanging tower CE certification program, content
European Union of medical equipment products are divided into four categories, namely: type I, Article II A, second class B, class III. First class products to add CE mark, can be taken to declare the way. The manufacturers make products technical file, while its own according to the relevant EN standards for product or commissioned tests of the ability of qualified laboratory for testing. Article II A, second class B, class III products to add CE mark, it must be by the European Union designated verifier verify. The EU is also provided, these kinds of products CE certification is a prerequisite for the factory to ISO9000+ISO13485 quality system certification, obtained ISO9000+ISO13485 quality system certification, and the unit should be awarded the certificate of accreditation of certification bodies. The ISO9000+ISO13485 quality system certification and CE certification at the same time, but the CE certificate must be ISO9000+ISO13485 quality system certification after passing, can be issued.
According to the European Union on product classification of medical hoist tower and related accessories such as: medical gas terminal ( CLASS IIA ) oxygen humidifier ( I + CLASS ) simple general negative pressure aspirator ( I + CLASS ) belongs to the class II B, CE certification program and the contents are as follows:
1) the enterprise is advanced to the certification body certification, certification inquiry and fill single cross certification body;
2) to apply for certification body certified enterprises offer single, complete enterprise signed contract;
3) the enterprise to the certification institution to submit ISO9000+ISO13485 quality system file of quality manual and procedure documents, for certification bodies documents audit; quality system audit, enterprises should have at least three months of quality system operation records, and completed the 1-2 internal quality audit system.
4) certification agency issued notice to the certified product testing certification bodies accredited laboratory, laboratory will apply for certification of products of low voltage ( LVD ) testing and electromagnetic compatibility ( EMC ) testing. Test if there is unqualified, by the enterprise reform after test again, until the test qualified. The end of the test, the laboratory test report issued.
5) enterprise writes of application certification product technical file (TCF file ). The test report as a TCF file contents. TCF file is the manufacturer to apply for CE certification CE certification body submitted an important document, it is the important basis of certification body certification audit. Preparation of TCF file must all use english. The TCF file includes seven aspects : 1 brief introduction: the product description; the design of the main contents of the file; the risk analysis and assessment; the test report and clinical diagnostic information; the file design control; the products for the declaration.
6) certification for the enterprise ISO9000+ISO13485 quality system and TCF documents for the trial. After the certification bodies will be pointed out that the quality system and TCF files in the problem of existence, enterprise should according to perfect quality system and TCF file.
7) certification for the enterprise ISO9000+ISO13485 quality system and TCF file a formal audit.
8) formal verification, certification bodies and enterprises signed a framework agreement, clearly obtained CE certificate after the parties should follow the principles and products using CE markers, as well as the measures for handling complaints. Then issue the ISO9000+ISO13485 quality system certification and CE certification mark.
In general, from enterprises to apply for certification to certification authority certificate need about a half year to one year.
The effectiveness of CE markers
Products made CE certification, you can quote on the CE logo, but only the application for certification submitted TCF described in the product, with CE signs mean that the product can enter the EU market and products made CE certification before entering the area of the countries and regions. Products CE certification is valid for five years. We obtained CE certificate for TCF documents submitted is the first generation of head medical hanging tower information, so the CE label can only be affixed to the first generation of head medical hanging tower. As the head of medical hoist tower has a significant change, must be submitted to CE attestation orgnaization change documents recertification, otherwise cannot add CE mark.