Article 1 In order to strengthen disinfection management, prevent and control the spread of infectious diseases and safeguard human health, these Measures are formulated in accordance with the relevant provisions of the Law of People's Republic of China (PRC) on the Prevention and Control of Infectious Diseases and its implementation measures.
Article 2 These Measures shall apply to medical and health institutions, disinfection service institutions and units and individuals engaged in production and business activities in disinfection products.
These Measures shall also apply to other places and articles that need disinfection.
Article 3 The Ministry of Health shall be in charge of the supervision and administration of disinfection throughout the country.
The competent department of railway and traffic health shall be responsible for the supervision and management of disinfection in this system in accordance with these measures.
Chapter II Requirements for Disinfection and Hygiene
Article 4 Medical and health institutions shall establish disinfection management organizations, formulate disinfection management systems, implement relevant national norms, standards and regulations, and regularly carry out disinfection and sterilization effect testing.
Article 5 The staff of medical and health institutions shall receive training in disinfection techniques, master disinfection knowledge, and strictly implement the disinfection and isolation system in accordance with regulations.
Article 6 Medical articles used by medical and health institutions that enter human tissues or sterile organs must meet the sterilization requirements. All kinds of injection, puncture and blood collection instruments should be disinfected by one person. All instruments and articles in contact with skin and mucous membranes must meet the disinfection requirements.
Disposable medical articles used by medical and health institutions shall be treated harmlessly in time after use.
Seventh medical and health institutions purchasing disinfection products must establish and implement the system of inspection and acceptance of incoming goods.
Article 8 The environment and articles of medical and health institutions shall conform to the relevant national norms, standards and regulations. The discharged waste water and sewage shall be treated harmlessly in accordance with the relevant provisions of the state. Vehicles, tools and contaminated articles that transport patients with infectious diseases must be disinfected at any time.
Article 9 When an infectious disease breaks out or spreads in a medical and health institution, it shall promptly report to the local health administrative department and take effective disinfection measures.
Article 10 The processing, sale and transportation of furs contaminated by infectious disease pathogens or from epidemic areas that may be contaminated by infectious disease pathogens shall be disinfected.
Eleventh child care institutions should improve and implement the disinfection management system, and regularly disinfect indoor air, tableware, towels, toys and other places where children can move and touch things.
Article 12 Units and individuals that rent or wash clothes shall disinfect related articles and places.
Thirteenth units engaged in pathogenic microorganism experiments should implement relevant management systems and operating procedures, and disinfect experimental equipment and contaminated articles according to regulations to prevent laboratory infection and the spread of pathogenic microorganisms.
Article 14 Articles in contact with the remains of funeral parlours and crematoriums and vehicles transporting the remains shall be disinfected in time.
Article 15 An employing unit that employs more than 200 migrant workers shall regularly disinfect the places where migrant workers live and live together and the articles used.
Article 16 The disinfection of epidemic spots shall conform to the relevant national norms, standards and regulations.
Seventeenth public places, food, drinking water and blood products disinfection management, according to the provisions of relevant laws and regulations.
Chapter III Production and Operation in disinfection products
Eighteenth disinfection products shall comply with the relevant national norms, standards and regulations.
Article 19 The production in disinfection products shall conform to the relevant national norms, standards and regulations, and the disinfection products produced shall be inspected, and the unqualified products shall not leave the factory.
Twentieth disinfectants, disinfection equipment, sanitary products and disposable medical supplies production enterprises shall obtain the hygiene license issued by the local provincial health administrative department before engaging in disinfection products production.
Twenty-first provincial health administrative departments shall, within one month from the date of accepting the application of disinfection products production enterprises, make a decision on whether or not to approve. In line with the requirements of the "Hygiene Code for Production Enterprises in disinfection products", a hygiene license shall be issued; Do not meet, not approved, and explain the reasons.
Article 22 The serial number format of hygiene license for production enterprises in disinfection products is: (hereinafter referred to as province, autonomous region and municipality directly under the Central Government) Xiao Wei Zheng Zi (year of issuance)No. ×××××.
The production items licensed by disinfection products production enterprises are divided into disinfectants, disinfection instruments, sanitary articles and disposable medical articles.
Twenty-third disinfection products production enterprises hygiene license is valid for four years, once a year.
Three months before the expiration of the hygiene license for production enterprises in disinfection products, the production enterprises shall apply to the original issuing authority for renewal of the hygiene license. If it meets the requirements after examination, a new certificate will be issued. The new certificate continues the original health permit number.
Twenty-fourth disinfection products production enterprises to relocate or set up another branch (workshop), should be in accordance with the provisions of these measures to the provincial health administrative department where the production site is located to apply for the hygiene license of disinfection products production enterprises.
The address and hygiene license number marked on the product package should be the address of the actual production place and its hygiene license number.
Article 25 Where a disinfection products production enterprise that has obtained a hygiene license changes its enterprise name, legal representative or production category, it shall apply to the original license-issuing authority and renew the license after examination and approval. The new certificate continues the original health permit number.
Twenty-sixth health care products and disposable medical supplies shall be filed with the provincial health administrative department before they are put on the market. When filing, the materials shall be submitted in accordance with the requirements of the Provisions on the Administration of the Filing of Sanitary Articles and Disposable Medical Articles formulated by the Ministry of Health.
The provincial health administrative department shall, within fifteen days from the date of accepting the application, issue a record certificate to those who meet the requirements. The format of the record number is: (province, autonomous region and municipality directly under the Central Government) Xiao Wei BYZ (year of issuance)No. ×××××. If it is not filed, it shall explain the reasons.
The filing certificate is valid throughout the country.
Twenty-seventh imported sanitary articles and disposable medical articles shall be filed with the Ministry of Health before entering the China market for sale for the first time. When filing, the materials shall be submitted in accordance with the requirements of the Provisions on the Administration of the Filing of Sanitary Articles and Disposable Medical Articles formulated by the Ministry of Health. When necessary, the Ministry of Health may conduct on-site audit of production enterprises.
The Ministry of Health shall, within fifteen days from the date of accepting the application, issue a record certificate to those who meet the requirements. The format of the record number is: Jinbeizi (year of issuance)No. ×××××. If it is not filed, it shall explain the reasons.
Twenty-eighth the production of disinfectants and disinfection equipment shall obtain the hygiene license issued by the Ministry of Health in accordance with the provisions of these measures.
Twenty-ninth production enterprises to apply for disinfectants, disinfection equipment hygiene license approval procedures are:
(a) the production enterprise shall apply to the local provincial health administrative department in accordance with the requirements of the Ministry of Health's "disinfection products Declaration and Acceptance Standard", and the provincial health administrative department shall conduct a preliminary examination of the application materials and samples;
(two) the provincial health administrative department shall complete the examination of the completeness, legality and standardization of the application materials within one month from the date of acceptance, and only after passing the examination can it be reported to the Ministry of Health for examination and approval;
(three) the Ministry of health shall make a decision on whether to approve or not within four months from the date of accepting the declaration.
The Ministry of Health will issue the Approval Number of Hygienic License for Disinfectants and Disinfectants to the approved products, and the format of the approval number is: Zi (Year)No. ×××××. If it is not approved, it shall explain the reasons.
Article 30 Anyone who applies for the approval of sanitary license for imported disinfectants and disinfection equipment shall directly apply to the Ministry of Health, and submit relevant materials in accordance with the requirements of the Ministry of Health's disinfection products Declaration and Acceptance Standard. When necessary, the Ministry of Health may conduct on-site audit of production enterprises.
The Ministry of Health shall make a decision on whether to approve or not within four months from the date of accepting the declaration. For those who are approved to import, a Hygiene Permit for Imported Disinfectants and Disinfectants shall be issued, with the approval number format: Xiao Wei Jinzi (Year)No. ×××××. If it is not approved, it shall explain the reasons.
Thirty-first disinfectants, disinfection equipment hygiene license documents are valid for four years. Six months before the expiration of the validity period, the manufacturer or agent of the imported products shall apply for renewal of the hygiene license in accordance with the requirements of the disinfection products Declaration and Acceptance Standard of the Ministry of Health. If the extension is approved, the approval document of the health permit shall continue the original approval number.
Thirty-second operators to buy disinfection products, shall obtain the following valid documents:
(a) a copy of the hygiene license of the production enterprise;
(two) a copy of the product registration certificate or health permit approval.
A copy of the valid certificate shall be stamped with the seal of the original holder.
Thirty-third disinfection products's name and label (including instructions) shall comply with the relevant provisions of the Ministry of health.
Disinfection products's labels (including instructions) and publicity contents must be true, and may not have therapeutic effects on diseases.
Thirty-fourth prohibit the production and operation of the following disinfection products:
(1) The production enterprise has no hygiene license, product filing certificate or hygiene license approval;
(2) The sanitary quality of the products does not meet the requirements.
Chapter IV Disinfection Service Institutions
Thirty-fifth disinfection service institutions shall apply to the provincial health administrative department and obtain the health license issued by the provincial health administrative department before they can carry out disinfection services.
The numbering format of the Hygiene Permit for Disinfection Service Institutions is: (province, autonomous region and municipality directly under the Central Government)No. ××× If it meets the requirements after examination, a new certificate will be issued. The new certificate continues the original health permit number.
Thirty-sixth disinfection service institutions shall meet the following requirements:
(a) with disinfection and sterilization equipment in line with relevant national norms, standards and regulations;
(2) Its disinfection and sterilization process and working environment must meet the hygiene requirements;
(3) Having the personnel and conditions to detect the disinfection and sterilization effect, and establishing a self-inspection system;
(4) Where ethylene oxide and ionizing radiation are used for disinfection and sterilization, safety and environmental protection requirements shall be implemented in accordance with relevant state regulations;
(5) Personnel engaged in ethylene oxide and ionizing radiation disinfection services must receive professional and technical training from provincial health administrative departments, and personnel engaged in other disinfection services must receive professional and technical training organized by health administrative departments at or above the city (prefecture) level and obtain corresponding qualification certificates before taking up their posts.
Thirty-seventh disinfection service institutions shall not purchase and use disinfection products that does not conform to the provisions of these measures.
Thirty-eighth disinfection service institutions shall accept the supervision of the local health administrative department.
Chapter V Supervisors
Thirty-ninth health administrative departments at or above the county level shall exercise the following supervision and management functions and powers on disinfection work:
(a) to supervise and inspect the disinfection work of relevant institutions, places and articles;
(two) to supervise and inspect the implementation of the "Hygienic Standards for Production Enterprises in disinfection products" by production enterprises in disinfection products;
(three) to supervise and inspect the health quality of disinfection products;
(four) supervision and inspection of disinfection service quality of disinfection service institutions;
(five) to take administrative control measures against acts in violation of these measures;
(six) to give administrative punishment for acts in violation of these measures.
Fortieth in any of the following circumstances, the administrative department of health at or above the provincial level may re-examine disinfection products City, which has obtained the approval document and filing certificate of health license:
(a) the authenticity of the product formula and production process is questioned;
(two) the product safety and disinfection effect are questioned;
(three) the product promotion content and label (including instructions) are questioned.
Article 41 The holder of the health permit approval document in disinfection products shall, within one month after receiving the notice of reexamination from the health administrative department at or above the provincial level, submit materials according to the relevant requirements of the notice. Failure to submit relevant materials within the above-mentioned time limit shall be deemed as abandonment of re-inspection, and the health administrative department at or above the provincial level may cancel the approval number or filing number of the product hygiene license.
Article 42 The health administrative department at or above the provincial level shall make a re-examination decision within one month from the date of receiving all the materials required for re-examination. In any of the following circumstances, the approval number or filing number of the product hygiene license shall be cancelled:
(1) changing the product name, formula and production process without authorization;
(two) the product safety and disinfection effect can not meet the requirements;
(3) exaggerating publicity.
Forty-third disinfection products inspection institutions shall be approved by the administrative department of health at or above the provincial level. Without identification, shall not engage in disinfection products inspection work.
The inspection and evaluation report issued by disinfection products inspection agency shall be objective and true, and conform to relevant norms, standards and regulations.
The inspection report issued by disinfection products inspection agency is valid nationwide.
Forty-fourth disinfection products inspection agencies issued false inspection reports or neglected management to ensure the quality of inspection, the health administrative department at or above the provincial level shall order it to make corrections and give it a informed criticism; If the circumstances are serious, the qualification will be cancelled. An inspection institution that has been disqualified from accreditation shall not reapply for accreditation within two years.
Chapter VI Punishment Rules
Article 45 Where a medical and health institution violates the provisions of Articles 4, 5, 6, 7, 8 and 9 of these Measures, the local health administrative department at or above the county level shall order it to make corrections within a time limit and may impose a fine of not more than 5,000 yuan; Those who cause an outbreak of infectious diseases may be fined between 5,000 yuan and 20,000 yuan.
Article 46 Whoever fails to disinfect, sell or transport furs contaminated or possibly contaminated by infectious disease pathogens from epidemic areas shall be punished in accordance with the relevant provisions of Article 68 of the Measures for the Implementation of the Law on the Prevention and Control of Infectious Diseases.
Forty-seventh disinfection products production and business units in violation of the provisions of article thirty-third, article thirty-fourth, the local health administrative departments at or above the county level shall be ordered to make corrections within a time limit, and may impose a fine of 5000 yuan; Those who cause an outbreak of infectious diseases may be fined between 5,000 yuan and 20,000 yuan.
Forty-eighth disinfection service institutions in violation of the provisions of these measures, one of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit, and may be fined up to 5000 yuan; Causing the occurrence of infectious diseases, can be more than 5000 yuan to 20000 yuan fine:
(a) disinfection items do not meet the hygiene standards and requirements;
(two) engaged in disinfection services without obtaining a hygiene license.
Chapter VII Supplementary Provisions
Article 49 The meanings of the following terms in these Measures:
Infectious diseases: diseases caused by microorganisms.
Disinfection products: Including disinfectants, disinfection instruments (including biological indicators, chemical indicators and (packaging of sterilized articles), sanitary articles and disposable medical articles.
Disinfection service organization: refers to the unit that provides disinfection and sterilization services for articles and places that may be contaminated, sanitary articles and disposable medical articles.
Medical and health institutions: refer to medical and health care, disease control, blood collection and supply institutions and units with the same business activities as the above institutions.
Article 50 The Ministry of Health shall be responsible for the interpretation of these Measures.
Article 51 These Measures shall come into force as of July 6, 2002. The Measures for the Administration of Disinfection issued by the Ministry of Health on August 3 1 65438,0992 shall be abolished at the same time.