Medical device products to successfully pass the CE certification, need to do three aspects of work

 

First, collect European Union technical regulations and European Union (EN) standards related to certified products, through digestion, absorption, and incorporation into enterprise product standards.

 

Second, enterprises in strict accordance with the above product standards to organize production, that is, the requirements of the above technical regulations and EN standards, implemented into the whole process of product design and development and manufacturing.

 

Third, the enterprise must build and maintain the quality system according to ISO9000+ISO13485 standards, and obtain ISO9000+ISO13485 certification.  

 

Eu Technical regulations and EN Standards for CE certification of medical devices

 

For the 18 types of industrial product directives issued by the EU at present, from the structure of these directives, they can be divided into vertical directives and horizontal directives. Vertical instructions are for specific products, such as medical device instructions; The horizontal directive applies to various product lines, such as the Electromagnetic Compatibility Directive, which applies to all electrical and electronic component products.

 

For medical devices, there are fourteenth, first and fifth directives applicable, namely: 93/42/EEC Medical Devices Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic Compatibility (EMC) Directive.

 

The EU standards supporting these directives are:

 

(1) EN60601-1 Medical electrical equipment Part 1: General safety requirements;

 

(2) EN60601-1-1 Medical electrical equipment Part 1: General safety requirements and Amendment No. 1;

 

(3) EN60601-2-11 Medical electrical equipment Part 2: γ Specific safety requirements for beam therapy equipment;

 

(4) EN60601-1-2 Medical electrical equipment Part 1: General requirements for Safety Section 1.2 Parallel standard Electromagnetic compatibility — — Requirements and tests. Among them, (1), (2) and (3) standards are the basis for Gamma knife low voltage (LVD) testing: (4) standards are the basis for gamma knife electromagnetic compatibility (EMC) testing.