NEWS
HOME > News
NEWS
2013-06-10
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
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. Vertical 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.
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
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. Vertical 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.
