, namely diagnostic equipment, therapeutic equipment and auxiliary equipment.
I.Diagnosis equipment can be divided into eight categories :
X-Ray Diagnostic Equipment, Ultrasound Diagnostic Equipment, Features 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 Bottles, etc.); Surgical equipment (surgical beds, lighting equipment, surgical instruments, etc.); Radiation therapy equipment (contact therapy machines, superficial treatment machines, etc.); Nuclear medicine treatment equipment - Treatment methods are internal irradiation treatment, application therapy and colloid Treatment of three kinds; physical and chemical equipment (generally can be divided into phototherapy business, electrotherapy equipment, ultrasound therapy and sulfur therapy equipment 4); laser equipment - medical laser generator (commonly used ruby laser, He-Ne laser, carbon dioxide laser, argon Ion laser, YAG laser, etc.); dialysis treatment equipment (common artificial kidneys include 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 (heart Defibrillation pacing equipment, artificial respirator, ultrasonic nebulizer, etc.); other therapeutic equipment (hyperbaric oxygen chamber, ophthalmic high-frequency electrochromic device, etc.).
Three, auxiliary equipment can be divided into the following categories Class:
disinfection and sterilization equipment, refrigeration equipment, and central attraction And oxygen systems, air conditioning equipment, pharmaceutical machinery and equipment, blood bank equipment, medical data processing equipment, medical video photography equipment.
Three aspects of work.
First, collect EU products related to certified products Technical regulations and European Union (EN) standards are adopted through the digestion, absorption, and inclusion of enterprise product standards.
Second, the company strictly follows the above product standards Production, that is, the requirements of the above technical regulations and EN standards, the implementation of the enterprise product design and development and manufacturing of the entire process.
Third, companies must comply with ISO9000 + ISO13485 standards Build and maintain quality system and obtain ISO9000+ISO13485 certification.
EU CE regulations for medical device CE certification And EN standards
For the current EU directive on 18 types of industrial products, From the structure of these instructions, they can be divided into vertical instructions and horizontal instructions. Vertical commands are specific products, such as medical device directives; horizontal commands are applicable to various product lines, such as electromagnetic compatibility directives, which apply to all electrical and electronic component products.
For medical devices, there are fourteen applicable directives The first and fifth items are: 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic Compatibility (EMC) Directive.
EU standards that support these directives:
(1) EN60601-1 Medical Electrical Equipment Part: General requirements for safety;
(2) EN60601-1-1 Medical Electrical Part I of the equipment: General requirements for safety and amendment No. 1;
(3) EN60601-2-11 Medical Electrical Equipment Part II: Specific requirements for the safety of gamma beam therapy equipment;
(4) EN60601-1-2 Medical Electrical Equipment Part I: Safety General Requirements Section 1.2 Parallel Standards Electromagnetic Compatibility - Requirements and Testing. The first (1), (2) and (3) criteria are the basis for the gamma knife low voltage (LVD) test: the criterion (4) is the basis for the gamma knife electromagnetic compatibility (EMC) test.