200 1 1 1 will be realized.
Chapter I General Provisions Article 1 This hygienic standard is formulated for the purpose of strengthening the hygienic management of production enterprises in disinfection products and ensuring the hygienic quality and the safety of consumers in disinfection products.
Article 2 This Code is formulated in accordance with the Law of People's Republic of China (PRC) on the Prevention and Control of Infectious Diseases and its implementation measures and disinfection management measures.
Article 3 disinfection products referred to in this specification includes disinfectants, disinfection instruments, disposable medical and health supplies and indicating equipment for evaluating disinfection and sterilization effects.
Article 4 Enterprises engaged in production in disinfection products must abide by this Code.
Fifth local people's health administrative departments at all levels shall supervise the implementation of this specification.
Chapter II Production Environment and Layout Article 6 A production enterprise shall be built in a clean area free from stagnant water, weeds, garbage, mosquitoes, flies and pests.
Disposable medical supplies production enterprises should be 500 meters away from the pollution sources that affect the sanitary quality of products, and the surrounding environment of the factory should be green.
Article 7 The layout of production enterprises shall be reasonable and meet the corresponding hygiene requirements. The production area and non-production area shall be set to ensure the continuity of production, and there shall be no reverse crossing.
Article 8 The production layout must conform to the production technology, including raw material room, production workshop, finished product room and quality inspection department. It should be set up and the production process should be reasonably connected.
Article 9 Anyone who uses or produces toxic, harmful, flammable and explosive substances in the production process must have corresponding health and safety facilities and comply with the relevant state regulations on health and safety.
Tenth power, heating, air conditioning room, water supply and drainage system and waste water, waste gas, waste residue treatment system and other auxiliary buildings and facilities shall not affect the production hygiene.
Chapter III Hygienic Requirements for Production Areas Article 11 The production areas must be equipped with dressing rooms, and there should be dressing facilities such as wardrobes and shoe racks, as well as tap water washing and disinfection facilities.
Article 12 Toilets in production areas must be flush type and kept clean and hygienic.
Thirteenth floors, walls, tops and countertops of production workshops should be easy to clean and disinfect. Dust-free materials should be selected for interior decoration in purification workshop.
Article 14 A production enterprise must have equipment suitable for the production characteristics of products, meet production needs and ensure the hygienic quality of products.
Fifteenth production enterprises should take disinfection measures for the workshop environment according to the hygiene requirements of product production.
Sixteenth production equipment, tools, containers, places, work clothes, hats and shoes should be cleaned and disinfected according to the characteristics of the products before use.
Seventeenth production water quality should meet the requirements of production technology.
Sterile water should be used in the production of contact lens care solution and products with special hygiene requirements.
Disinfectant production water should meet the sanitary standard of drinking water.
The washing water used in the production of disposable medical supplies should meet the standards of deionized water and water for injection.
Article 18 The production and sub-packaging of disposable medical supplies, contact lens care solutions and disinfection products with special hygiene requirements that enter human sterile tissues and organs must be carried out in purification workshop with cleanliness100000 or above.
Article 19 The hygienic requirements of production workshops in disinfection products shall be implemented in accordance with GB 15979, GB 15980 and relevant national hygienic standards.
Chapter IV Hygienic Requirements for Packaging and Storage of Raw Materials and Products Article 20 Raw materials used in the production of disposable medical and health products must be non-toxic, harmless and pollution-free, and there must be corresponding inspection reports or certification materials.
Twenty-first raw materials and finished products must be stored separately and clearly marked. The warehouse should have ventilation, dust prevention, rodent prevention, insect prevention and other facilities, and the storage should be kept dry and tidy, which should meet the corresponding preservation requirements of products.
Disposable medical and health supplies should be stored at a place not less than 10 cm from the ground and walls and not less than 50 cm from the top.
Twenty-second products to be inspected, qualified products and unqualified products should be stored separately and clearly marked for easy identification. There should be a registration and acceptance system for products in and out of storage, and records should be kept for future reference.
Chapter V Hygiene Quality Control Article 23 Enterprises shall establish and improve the hygiene quality assurance system for product production, and the hygiene indicators and inspection methods in the product enterprise standards or quality standards shall meet the requirements of relevant national hygiene standards and technical specifications.
Article 24 An enterprise shall establish a self-inspection system and equip it with corresponding testing instruments and equipment. Measuring instruments used for production and inspection shall be regularly verified as required and recorded for future reference.
Twenty-fifth personnel engaged in health quality inspection must pass the examination by the provincial health administrative department and obtain the post certificate.
Twenty-sixth each batch of products must be inspected for hygiene and quality before they are put on the market.
Twenty-seventh enterprises should carry out self-inspection of workshop environmental hygiene and product hygiene quality according to product characteristics, and the self-inspection items of different product manufacturers:
(a) disinfection equipment manufacturers should detect the intensity of disinfection factors or physical and chemical indicators related to disinfection and sterilization effect of each product;
(2) Disinfectant production enterprises should detect the physical and chemical indexes of each batch of raw materials and products produced by each team. If there is no specific effective content detection method, such as plants, biological extracts and other products, corresponding technical parameters, detection indicators and methods should be established to ensure product quality;
(3) Indicating equipment for evaluating disinfection and sterilization effect shall establish corresponding technical parameters, testing indexes and methods that can ensure product quality;
(four) disposable medical supplies production enterprises should carry out microbial indicators testing on the products produced in each class;
(five) sanitary products production enterprises should carry out microbial indicators testing for each batch of products produced;
Twenty-eighth product quality inspection records and reports shall be complete, and shall not be arbitrarily altered, using legal units of measurement.
Article 29 The original records of the production process shall be properly kept for three months after the shelf life of the product.
Chapter VI Personnel Requirements Article 30 Enterprises must be equipped with full-time or * * * health management personnel who have received professional training, and the list of management personnel shall be submitted to the provincial health administrative department for the record.
Thirty-first operators directly engaged in disinfection products production must undergo health examination before taking up their posts and every year, and can only take up their posts after obtaining the certificate of preventive health examination.
Patients with active tuberculosis, viral hepatitis, intestinal infectious diseases and pathogen carriers, patients with purulent or chronic exudative skin diseases and patients with other infectious diseases shall not engage in the production of disposable medical and health supplies.
Thirty-second production personnel must be trained in disinfection and hygiene knowledge and related hygiene standards before taking up their posts, and can only take up their posts after obtaining the certificate of hygiene training.
Thirty-third staff should wear clean work clothes, and their opponents should be cleaned and disinfected according to the product hygiene requirements before operation.
Employees engaged in disposable medical and health products are not allowed to wear jewelry, watches, dye nails or grow long nails in the production process.
Thirty-fourth staff members shall not engage in activities that affect health and product quality, such as smoking, eating and drinking.
Chapter VII Supplementary Provisions Article 35 The meanings of the following terms in this specification are:
Product batch: if the product is finally sterilized, the sterilized batch shall be the product batch; Other products are made from the same batch of raw materials under the same production conditions.
Purification workshop with cleanliness of 65438+ 100000: It is designed according to strict control area and clean area. Indoor environment and appliances shall be made of materials that are dust-free, easy to clean and disinfect. Through physical filtration and directional ventilation, the indoor microclimate can meet the following requirements: temperature 18-28℃, relative humidity 50-65%, wind speed at air inlet not less than 0.25m/s, number of particles ≥0.5цm in the air not more than 3,500 /L, number of bacterial colonies in the air not more than 500 cfu/m3, and bacteria on the surface of objects.
Article 36 The Ministry of Health shall be responsible for the interpretation of this Code.
Article 37 This Specification shall be implemented as of 20011.