There are three major categories of medical devices that are promoted, namely, diagnostic equipment, therapeutic equipment, and auxiliary equipment.
First, the diagnostic equipment class can be divided into eight categories:
X-ray diagnostic equipment, ultrasonic diagnostic equipment, functional inspection equipment, endoscopy equipment, nuclear medicine equipment, laboratory diagnostic equipment, and pathological diagnostic equipment.
Second, the treatment equipment can be divided into 10 categories:
Ward care equipment (beds, carts, oxygen cylinders, etc.); surgical equipment (surgical beds, lighting equipment, surgical instruments, etc.); radiotherapy equipment (contact therapy machines, superficial treatment machines, etc.); nuclear medicine treatment equipment - treatment methods There are three kinds of internal irradiation treatment, application treatment and colloid treatment; physical and chemical equipment (substantially can be divided into phototherapy business, electrotherapy equipment, ultrasonic treatment and sulphur treatment equipment 4); laser equipment - medical laser generator (commonly used ruby Laser, holmium laser, carbon dioxide laser, argon ion laser and YAG laser, etc.; dialysis treatment equipment (common artificial kidney has flat artificial kidney and tubular artificial kidney); body temperature freezing equipment (semiconductor cold knife, gas cold knife and Solid cold knife, etc.; First aid equipment (cardiac defibrillation pacing equipment, artificial ventilator, ultrasonic nebulizer, etc.); other treatment equipment (hyperbaric oxygen chamber, high-frequency electric chrome for ophthalmology, etc.).
Third, auxiliary equipment classes can be divided into the following categories:
Disinfection and sterilization equipment, refrigeration equipment, central suction and oxygen supply systems, air conditioning equipment, pharmaceutical machinery equipment, blood bank equipment, medical data processing equipment, medical video photography equipment, etc.
Medical device products must pass three CE certifications in order to successfully pass CE certification.
First, collect EU technical regulations and EU (EN) standards related to certified products, through digestion, absorption, and inclusion of corporate product standards.
Second, the company organizes production in strict accordance with the above product standards, that is, the requirements of the above technical regulations and EN standards are implemented in the whole process of design, development and manufacturing of enterprise products.
Third, the company must establish and maintain a quality system in accordance with ISO9000+ISO13485 standards and obtain ISO9000+ISO13485 certification.
EU technical regulations and EN standards for medical device CE certification
For the current 18 types of industrial product orders issued by the European Union, from the structure of these instructions, they can be divided into vertical instructions and horizontal instructions. Vertical instructions are for specific products, such as medical device instructions; horizontal instructions are applicable to various product lines, such as electromagnetic compatibility directives, which are applicable to all electrical and electronic components.
For medical devices, the applicable directives are Articles 14, 1 and 5, namely: 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic Compatibility (EMC) directive.
The EU standards that support these directives are:
(1) EN60601-1 medical electrical equipment Part 1: General requirements for safety;
(2) EN60601-1-1 medical electrical equipment Part 1: General requirements for safety and amendment No. 1;
(3) EN60601-2-11 medical electrical equipment Part II: Safety requirements for gamma beam therapy equipment;
(4) EN60601-1-2 Medical Electrical Equipment Part 1: Safety General Requirements Section 1.2 Parallel Standard Electromagnetic Compatibility - Requirements and Testing. The criteria in items (1), (2), and (3) are the basis for the gamma knife low voltage (LVD) test: the standard (4) is the basis for the gamma knife electromagnetic compatibility (EMC) test.
