Medical products

There are three categories of medical equipment that are more advocated, namely, diagnostic equipment, therapeutic equipment, and auxiliary equipment.

        1. Diagnostic equipment 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 diagnosis equipment.

        2. The treatment equipment category can be divided into 10 categories:

        Ward nursing equipment (patient beds, carts, oxygen cylinders, etc.); surgical equipment (surgical beds, lighting equipment, surgical instruments, etc.); radiotherapy equipment (contact treatment machines, shallow treatment machines, etc.); nuclear medicine treatment equipment-treatment methods There are three types of internal radiation therapy, application therapy and colloid therapy; physical and chemical equipment (which can be roughly divided into four categories: phototherapy business, electrotherapy equipment, ultrasonic therapy and sulfur therapy equipment); laser equipment-medical laser generator (commonly used is ruby Laser, helium-neon laser, carbon dioxide laser, argon ion laser and YAG laser, etc.); dialysis treatment equipment (commonly used artificial kidneys include flat-plate 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 and pacing equipment, artificial ventilator, ultrasonic nebulizer, etc.); other treatment equipment (hyperbaric oxygen chamber, high-frequency electrochromic device for ophthalmology, etc.).

        3. Auxiliary equipment can be divided into the following categories:

        Disinfection and sterilization equipment, refrigeration equipment, central suction and oxygen supply system, air-conditioning equipment, pharmaceutical machinery equipment, blood bank equipment, medical data processing equipment, medical video and photography equipment, etc.

        For medical device products to successfully pass CE certification, three aspects need to be done.

        First, collect EU technical regulations and EU (EN) standards related to certified products, and incorporate them into enterprise product standards through digestion, absorption, and inclusion.

        Second, the company organizes production strictly in accordance with the above product standards, which means that the requirements of the above technical regulations and EN standards are implemented in the entire process of product design, development and manufacturing.

        Third, companies must build and maintain a quality system in accordance with ISO9000+ISO13485 standards, and obtain ISO9000+ISO13485 certification.

        European technical regulations and EN standards that should be followed for the CE certification of medical devices

        Regarding the 18 types of industrial product directives issued by the European Union, judging from the structure of these directives, they can be divided into vertical directives and horizontal directives. The vertical directive is aimed at specific products, such as the medical device directive; the horizontal directive applies to various product series, such as the electromagnetic compatibility directive, which applies to all electrical and electronic parts products.

        For medical devices, the fourteenth, first and fifth directives are applicable, 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 Safety Requirements and No. 1 Amendment;

        (3) EN60601-2-11 Medical Electrical Equipment Part II: Special requirements for the safety of gamma beam therapy equipment;

        (4) EN60601-1-2 Medical Electrical Equipment Part 1: General Safety Requirements Section 1.2 Parallel Standard Electromagnetic Compatibility-Requirements and Testing. Among them, the standards (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.