Acceptance Mark
20130610 Safety Information
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 standards.

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

and development and manufacturing of the entire process.

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

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. Vertical instructions are specific

for the object, such as the Medical Device Directive; horizontal directive applies to all kinds

products, such as electromagnetic compatibility directive, which applies to all electrical and

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

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


(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.