Acceptance Mark
What is "Medical Device CE certification" certification?
Medical equipment products to be passed CE certification, need to do work in three areas .

First, the collection and certification of products related to EU technical regulations and

European (EN) standards, through digestion, absorption, into the enterprise product


Second, enterprises in strict accordance with the above product standards organization of

production, that is, the above-mentioned technical regulations and EN standards, implement

enterprise product design and development and manufacturing of the entire process .

Third, companies must build and maintain the standard ISO9000 + ISO13485 quality system

and obtained ISO9000 + ISO13485 certification.

Medical Device CE certification should follow the EU technical regulations and EN standards.

For the EU published Directive 18 categories of industrial products from these directives

structure, they can be divided into vertical and horizontal directive instruction .

instructions are specific products for the object, such as the Medical Device Directive ;

horizontal directive applies to all kinds of products , such as electromagnetic compatibility

directive , which applies to all electrical and electronic parts and components.

For medical devices , the applicable directives has fourteenth , the first and fifth ,

namely : 93/42/EEC Medical Device Directive , 73/23/EEC Low Voltage (LVD) Directive

89/336/EEC Electromagnetic Compatibility
Xing (EMC) directive .

EU standards support these commands are:

(1) EN60601-1 Medical Electrical Equipment Part I: General requirements for safety ;

(2) EN60601-1-1 Medical Electrical Equipment Part I: General Requirements for Safety

     and First Amended ;

(3) EN60601-2-11 Medical electrical equipment Part II : γ beam therapy equipment safety

     requirements ;

(4) EN60601-1-2 Medical Electrical Equipment Part I: General Requirements for Safety

     1.2 Parallel standard Electromagnetic compatibility - Requirements and tests.

     The first ( 1 ) , ( 2 ) , ( 3 ) criteria is Gamma Knife Low Voltage (LVD) test based on:

     No. ( 4 ) criteria is Gamma Knife electromagnetic compatibility (EMC) test basis.