Adopted at the 10 executive meeting in the State Council on June 4, 2003.
It is hereby promulgated and shall come into force as of the date of promulgation.
Chapter I General Provisions Article 1 In order to strengthen the safety management of medical wastes, prevent the spread of diseases, protect the environment and safeguard human health, these Regulations are formulated in accordance with the Law of People's Republic of China (PRC) on the Prevention and Control of Infectious Diseases and the Law of People's Republic of China (PRC) on the Prevention and Control of Environmental Pollution by Solid Wastes.
Article 2 The term "medical waste" as mentioned in these Regulations refers to the waste that is directly or indirectly infectious, toxic and other harmful in medical treatment, prevention, health care and other related activities produced by medical and health institutions.
The classified catalogue of medical wastes is jointly formulated and published by the health administrative department and the environmental protection administrative department of the State Council.
Article 3 These Regulations shall apply to the collection, transportation, storage, disposal, supervision and management of medical wastes.
Domestic garbage generated by patients with infectious diseases or suspected patients with infectious diseases admitted by medical and health institutions shall be managed and disposed of according to medical wastes.
The management of narcotic drugs, psychotropic drugs, radioactive drugs, toxic drugs and related wastes abandoned by medical and health institutions shall be implemented in accordance with relevant laws, administrative regulations and relevant state regulations and standards.
Article 4 The State promotes the centralized and harmless disposal of medical wastes and encourages the research and development of technologies for the safe disposal of medical wastes.
Local people's governments at or above the county level are responsible for organizing the construction of centralized medical waste disposal facilities.
The state gives appropriate support to the construction of centralized medical waste disposal facilities in remote and poor areas.
Fifth people's health administrative departments at or above the county level shall implement unified supervision and management of disease prevention and control in the activities of medical waste collection, transportation, storage and disposal; The competent administrative department of environmental protection shall exercise unified supervision and management over the prevention and control of environmental pollution in the collection, transportation, storage and disposal of medical wastes.
The people's governments at or above the county level and other relevant departments shall be responsible for the supervision and management related to medical waste disposal within their respective functions and duties.
Article 6 Any unit or individual has the right to report, complain, report and accuse the illegal acts of medical and health institutions, centralized medical waste disposal units, supervision and management departments and their staff.
Chapter II General Provisions on Medical Waste Management Article 7 Medical and health institutions and centralized medical waste disposal units shall establish and improve the responsibility system for medical waste management, with its legal representative as the first responsible person, earnestly perform their duties, and prevent the spread of infectious diseases and environmental pollution accidents caused by medical wastes.
Eighth medical and health institutions and centralized medical waste disposal units shall formulate relevant rules and regulations and emergency plans for the safe disposal of medical waste; Set up a monitoring department or full-time (part-time) staff to be responsible for inspection, supervision and implementation of medical waste management in this unit, and prevent violations of these regulations.
Article 9 Medical and health institutions and centralized medical waste disposal units shall train the personnel and management personnel engaged in the collection, transportation, storage and disposal of medical wastes in relevant laws and professional knowledge, safety protection and emergency treatment.
Article 10 Medical and health institutions and centralized medical waste disposal units shall take effective occupational health protection measures, equip personnel and management personnel engaged in the collection, transportation, storage and disposal of medical wastes with necessary protective articles, and conduct regular health checks; When necessary, the relevant personnel shall be immunized to prevent their health from being damaged.
Eleventh medical and health institutions and centralized medical waste disposal units shall, in accordance with the provisions of the law of People's Republic of China (PRC) on the prevention and control of environmental pollution by solid waste, implement the management system of hazardous waste transfer.
Article 12 Medical and health institutions and centralized medical waste disposal units shall register medical waste, and the registration contents shall include the source, type, weight or quantity, handover time, disposal method, final destination and the signature of the disposer. Registration materials shall be kept for at least 3 years.
Thirteenth medical and health institutions and centralized medical waste disposal units should take effective measures to prevent the loss, leakage and spread of medical waste.
In case of loss, leakage and diffusion of medical waste, medical and health institutions and centralized medical waste disposal units shall take emergency measures to reduce the harm, and provide medical aid and on-site rescue for the sick; At the same time, report to the local county-level people's health administrative department and environmental protection administrative department, and inform the units and residents that may be harmed.
Article 14 No unit or individual may transfer or buy or sell medical wastes.
It is forbidden to discard medical wastes during transportation; It is forbidden to dump or pile up medical wastes in non-storage places, and medical wastes shall not be mixed with other wastes and domestic garbage.
Article 15 It is forbidden to mail medical wastes.
It is forbidden to transport medical wastes by rail or air.
Where there are land passages, it is forbidden to transport medical wastes by water; If there is no land passage and medical waste needs to be transported by water, it shall be approved by the competent administrative department of environmental protection of the people's government at or above the municipal level, and strict environmental protection measures shall be taken before it can be transported by water.
It is forbidden to carry passengers on the same vehicle to transport medical wastes.
It is forbidden to transport medical wastes on water bodies in drinking water source protection areas.
Chapter III Management of Medical Wastes by Medical and Health Institutions Article 16 Medical and health institutions shall collect medical wastes generated by their own units in a timely manner and put them in special packages or closed containers to prevent leakage and sharp instrument penetration.
Special packages and containers for medical wastes should have obvious warning signs and instructions.
The provisions on the standards and warning signs of special packages and containers for medical wastes shall be jointly formulated by the administrative departments of health and environmental protection of the State Council.
Seventeenth medical and health institutions shall establish temporary storage facilities and equipment for medical wastes, and shall not store medical wastes in the open air; The temporary storage time of medical wastes shall not exceed 2 days.
Temporary storage facilities and equipment for medical wastes should be far away from medical areas, food processing areas, personnel activity areas and domestic garbage storage places, and obvious warning signs and safety measures such as leakage prevention, rat prevention, mosquito and fly prevention, cockroach prevention, theft prevention and child contact prevention should be set up.
Temporary storage facilities and equipment for medical wastes shall be disinfected and cleaned regularly.
Article 18 Medical and health institutions shall collect and transport medical wastes to temporary storage places according to the internal transport time and route determined by their own units, and use special transport tools to prevent leakage and spillage.
After the vehicle is used, it shall be disinfected and cleaned in time at the place designated by the medical and health institution.
Nineteenth medical and health institutions shall, in accordance with the principle of centralized disposal nearby, timely hand over medical wastes to centralized disposal units for disposal.
High-risk wastes such as culture medium, specimens, strains and virus seed preservation solution of pathogens in medical wastes shall be disinfected on the spot before being handed over to the centralized medical waste disposal unit for disposal.
Twentieth sewage generated by medical and health institutions, infectious disease patients or suspected infectious disease patients' excreta, should be strictly disinfected in accordance with state regulations; It can only be discharged into the sewage treatment system after reaching the national discharge standard.
Twenty-first rural areas do not have the conditions for centralized disposal of medical waste, medical and health institutions shall, in accordance with the requirements of the health administrative department of the people's government at the county level and the administrative department of environmental protection, dispose of the medical waste generated on the spot. Self-disposal of medical wastes shall meet the following basic requirements:
(1) Disposable medical devices and medical wastes that are likely to cause injuries after use shall be disinfected and disfigured;
(2) If it can be burned, it should be burned in time;
(three) can not be burned, centralized landfill after disinfection.
Chapter IV Centralized Disposal of Medical WasteArticle 22 Units engaged in centralized disposal of medical wastes shall apply to the competent administrative department of environmental protection of the people's government at or above the county level for a business license; Units that have not obtained business licenses shall not engage in activities related to centralized disposal of medical wastes.
Article 23 A centralized medical waste disposal unit shall meet the following conditions:
(1) Having facilities or equipment for the storage and disposal of medical wastes that meet the requirements of environmental protection and hygiene;
(2) Having trained technicians and corresponding skilled workers;
(3) Having institutions and personnel responsible for detecting and evaluating the effect of medical waste disposal;
(4) Having rules and regulations to ensure the safe disposal of medical wastes.
Article 24 The storage and disposal facilities of centralized medical waste disposal units shall be far away from residential areas, water source protection areas and main roads, and keep an appropriate safety protection distance from workplaces such as factories and enterprises, and comply with the provisions of the competent administrative department of environmental protection of the State Council.
Twenty-fifth centralized medical waste disposal units should collect and transport medical waste to medical and health institutions at least once every two days, and be responsible for the storage and disposal of medical waste.
Article 26 When transporting medical waste, the centralized medical waste disposal unit shall abide by the provisions of the state on the management of dangerous goods transportation and use special vehicles with obvious medical waste identification. Special vehicles for medical waste shall meet the requirements of environmental protection and hygiene such as leakage prevention and spillage prevention.
After the special vehicle for transporting medical wastes is used, it shall be disinfected and cleaned in a timely manner in the centralized disposal place of medical wastes.
Special vehicles for transporting medical wastes shall not transport other articles.
Twenty-seventh centralized medical waste disposal units shall ensure safety in the process of transporting medical waste, and shall not discard or leave medical waste.
Twenty-eighth centralized medical waste disposal units should install online monitoring devices for pollutant discharge, and ensure that the monitoring devices are always in normal operation.
Twenty-ninth centralized medical waste disposal units shall conform to the standards and norms of environmental protection and hygiene stipulated by the state.
Thirtieth medical waste centralized disposal units shall, in accordance with the provisions of the administrative department of environmental protection and the administrative department of health, regularly test and evaluate the environmental pollution prevention and health effects of medical waste disposal facilities. The test and evaluation results are stored in the archives of the centralized medical waste disposal unit and reported to the local environmental protection administrative department and the health administrative department once every six months.
Thirty-first centralized medical waste disposal units shall collect medical waste disposal fees from medical and health institutions in accordance with the relevant provisions of the state.
Medical waste disposal fees paid by medical and health institutions in accordance with regulations can be included in medical costs.
Article 32 The centralized medical waste disposal area shall utilize and transform the existing solid waste disposal facilities and other facilities to centrally dispose of medical waste, and meet the basic environmental protection and hygiene requirements.
Thirty-third cities with no centralized disposal facilities or insufficient disposal capacity shall build centralized disposal facilities for medical wastes in cities with districts above the municipal level within 1 year from the date of implementation of these regulations; County-level cities should build centralized medical waste disposal facilities within 2 years. The construction of centralized medical waste disposal facilities in counties (banners) shall be stipulated by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
During the period when centralized medical waste disposal facilities are not built, the local people concerned shall organize the formulation of a transitional medical waste disposal plan that meets the requirements of environmental protection and hygiene, and determine the collection, transportation, disposal methods and disposal units of medical waste.
Chapter V Supervision and Management Article 34 The administrative departments of health and environmental protection of local people's governments at or above the county level shall, in accordance with the provisions of these Regulations and the division of responsibilities, supervise and inspect medical and health institutions and centralized medical waste disposal units.
Article 35 The health administrative department of the local people's government at or above the county level shall conduct regular supervision, inspection or spot checks on the disease prevention and control work and the health protection of staff during the collection, transportation, storage and disposal of medical wastes by medical and health institutions and centralized medical waste disposal units.
Article 36 The competent administrative department of environmental protection of the local people's government at or above the county level shall conduct regular supervision and inspection or spot checks on the prevention and control of environmental pollution in the process of collection, transportation, storage and disposal of medical wastes by medical and health institutions and centralized medical waste disposal units.
Thirty-seventh health administrative departments and environmental protection administrative departments shall regularly exchange the results of supervision and inspection and spot checks. In the supervision and inspection or spot check, it is found that there are potential safety hazards in medical and health institutions and centralized medical waste disposal units, and they shall be ordered to immediately eliminate the potential hazards.
Article 38 The administrative department of health and the administrative department of environmental protection shall, after receiving the reports, complaints, exposures and accusations of violations of these Regulations by medical and health institutions, centralized medical waste disposal units, supervision and management departments and their staff, promptly verify them, deal with them according to law, and announce the results.
Thirty-ninth health administrative departments and environmental protection administrative departments have the right to take the following measures when performing their duties of supervision and inspection:
(a) on-site inspection of the relevant units, to understand the situation, on-site monitoring, investigation and evidence collection;
(two) to consult or copy the relevant materials of medical waste management and collect samples;
(three) to order the units and individuals that violate the provisions of these regulations to stop the illegal acts;
(four) to seal up or temporarily detain places, equipment, means of transport and articles suspected of violating the provisions of these regulations;
(five) to investigate and deal with acts in violation of the provisions of these regulations.
Article 40 When an infectious disease spread or an environmental pollution accident occurs due to improper management of medical wastes, or there is evidence that an infectious disease spread or an environmental pollution accident may occur, the competent administrative department of health and the competent administrative department of environmental protection shall take temporary control measures to evacuate people and control the site, and if necessary, order them to stop operations that cause or may cause an infectious disease spread or an environmental pollution accident.
Forty-first medical and health institutions and centralized medical waste disposal units shall cooperate with the inspection, monitoring, investigation and evidence collection of relevant departments, and shall not refuse or obstruct or provide false materials.
Chapter VI Legal Liability Article 42 Where the local people's governments at or above the county level fail to organize the construction of centralized medical waste disposal facilities or organize the formulation of transitional medical waste disposal plans in accordance with the provisions of these Regulations, the people's governments at higher levels in informed criticism shall order the construction of centralized medical waste disposal facilities or organize the formulation of transitional medical waste disposal plans within a time limit; And can give administrative sanctions to the main leaders and responsible persons of * * *.
Article 43 If the people's governments at or above the county level fail to perform their duties of supervision and inspection in accordance with the provisions of these Regulations, and find that the illegal acts of medical and health institutions and centralized medical waste disposal units have not been dealt with in time, and measures have not been taken in time to reduce the harm when infectious diseases spread or environmental pollution accidents occur or may occur, and there are other dereliction of duty, dereliction of duty and dereliction of duty, the relevant departments of the people's governments at the same level or higher levels should pay attention to them. Causing the spread of infectious diseases or environmental pollution accidents, the principal responsible person, the responsible person in charge and other directly responsible personnel shall be given administrative sanctions of demotion, dismissal and expulsion according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 44 Where the competent administrative department of environmental protection of the people's government at or above the county level violates the provisions of these regulations and issues business licenses to the centralized medical waste disposal units, informed criticism, the competent administrative department of environmental protection of the people's government at the same level or the people's government at a higher level, shall order him to withdraw the illegally issued licenses; And the principal responsible person, the responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law.
Article 45 If a medical and health institution or a centralized medical waste disposal unit violates the provisions of these Regulations and has any of the following circumstances, the administrative department of health and the administrative department of environmental protection of the local people's government at or above the county level shall, according to the division of responsibilities, order it to make corrections within a time limit and give it a warning; If no correction is made within the time limit, a fine of 2,000 yuan to 5,000 yuan shall be imposed:
(a) the medical waste management system has not been established, or there is no monitoring department or full-time (part-time) staff;
(two) the relevant personnel have not received relevant legal and professional skills, safety protection and emergency treatment training;
(3) Failing to take occupational health protection measures for the personnel and management personnel engaged in the collection, transportation, storage and disposal of medical wastes;
(4) Failing to register the medical wastes or failing to save the registration materials;
(five) failing to disinfect and clean the used medical waste transport vehicles or transport vehicles in a timely manner at the designated place;
(6) Failing to collect and transport medical wastes in time;
(seven) failing to regularly test and evaluate the environmental pollution prevention and health effects of medical waste disposal facilities, or failing to record and report the testing and evaluation effects.
Article 46 If a medical and health institution or a centralized medical waste disposal unit violates the provisions of these Regulations and has any of the following circumstances, the health administrative department and the environmental protection administrative department of the local people's government at or above the county level shall, according to the division of responsibilities, order it to make corrections within a time limit, give it a warning and may also impose a fine of not more than 5,000 yuan; If no correction is made within the time limit, a fine of 5000 yuan or more and 30 thousand yuan or less shall be imposed:
(a) storage facilities or equipment do not meet the requirements of environmental protection and hygiene;
(2) Failing to put medical wastes into special packages or containers according to categories;
(3) Failing to use a special vehicle that meets the standards to transport medical wastes or using a vehicle that transports medical wastes to transport other articles;
(four) the online monitoring device for pollutant discharge is not installed or the monitoring device is not always in normal operation.
Article 47 If a medical and health institution or a centralized medical waste disposal unit is under any of the following circumstances, the health administrative department and the environmental protection administrative department of the local people's government at or above the county level shall, according to the division of responsibilities, order it to make corrections within a time limit, give it a warning and impose a fine of more than 5,000 yuan/kloc-0,000 yuan; If no correction is made within the time limit, a fine of 6.5438+0 million yuan and 30,000 yuan shall be imposed; Causing the spread of infectious diseases or environmental pollution accidents, the practice license or business license shall be withheld or revoked by the original issuing department; If the case constitutes a crime, criminal responsibility shall be investigated according to law:
(1) Discarding medical wastes during transportation, dumping or stacking medical wastes in non-storage places, or mixing medical wastes with other wastes and domestic garbage;
(two) the management system of hazardous waste transfer is not implemented;
(3) handing over medical wastes to units or individuals that have not obtained business licenses for collection, transportation, storage and disposal;
(four) the disposal of medical waste does not meet the standards and norms of environmental protection and hygiene stipulated by the state;
(5) Failing to strictly disinfect sewage, excreta of patients with infectious diseases or suspected patients with infectious diseases in accordance with the provisions of these Regulations, or failing to meet the national discharge standards and being discharged into the sewage treatment system;
(6) Failing to manage and dispose of domestic garbage generated by patients with infectious diseases or suspected patients with infectious diseases according to medical wastes.
Article 48 Where a medical and health institution, in violation of the provisions of this Ordinance, discharges sewage, excreta of patients with infectious diseases or suspected infectious diseases that do not meet the national standards into the urban drainage network, the construction administrative department of the local people's government at or above the county level shall order it to make corrections within a time limit, give it a warning and impose a fine of not less than 5,000 yuan but not more than 60,000 yuan; If no correction is made within the time limit, a fine of 6.5438+0 million yuan and 30,000 yuan shall be imposed; Causing the spread of infectious diseases or environmental pollution accidents, the original license issuing department shall temporarily suspend or revoke the practice license; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 49 If medical and health institutions and centralized medical waste disposal units fail to take emergency measures or report to the competent administrative department of health and the competent administrative department of environmental protection in time, the competent administrative department of health or the competent administrative department of environmental protection of the local people's government at or above the county level shall, according to the division of responsibilities, order them to make corrections, give them a warning and impose a fine of 654.38 million yuan to 30,000 yuan; Causing the spread of infectious diseases or environmental pollution accidents, the practice license or business license shall be withheld or revoked by the original issuing department; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 50 Where a medical and health institution or a centralized medical waste disposal unit obstructs the law enforcement personnel of the health administrative department and the environmental protection administrative department from performing their official duties without justifiable reasons, refuses the law enforcement personnel to enter the site, or fails to cooperate with the inspection, monitoring, investigation and evidence collection of the law enforcement department, the health administrative department and the environmental protection administrative department of the local people's government at or above the county level shall, according to their respective duties, order them to make corrections and give them a warning; Refuses to correct, the license or business license shall be withheld or revoked by the original issuing department; Violation of the Regulations of the People's Republic of China on Administrative Penalties for Public Security, which constitutes a violation of public security administration, shall be punished by the public security organs according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 51 In rural areas that do not have the conditions for centralized disposal of medical wastes, if medical and health institutions fail to dispose of medical wastes in accordance with the requirements of these Regulations, the administrative department of health of the people's government at the county level or the administrative department of environmental protection shall, in accordance with the division of responsibilities, order them to make corrections within a time limit and give them a warning; If no correction is made within the time limit, a fine ranging from 1000 yuan to 5,000 yuan shall be imposed; Causing the spread of infectious diseases or environmental pollution accidents, the original license issuing department shall temporarily suspend or revoke the practice license; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 52 Whoever engages in the collection, transportation, storage and disposal of medical wastes without a business license shall be ordered by the competent administrative department of environmental protection of the local people's government at or above the county level to immediately stop the illegal act, confiscate the illegal income, and may also be fined more than 1 times and less than 1 times the illegal income.
Article 53 Where medical wastes are transferred, bought, sold, mailed, transported by air or by water in violation of the provisions of these Regulations, the competent administrative department of environmental protection of the local people's government at or above the county level shall order the transferor, the buyer and seller, the mailer and the shipper to immediately stop their illegal acts, give a warning and confiscate their illegal income; Illegal income of more than 5000 yuan, and impose a fine of more than 2 times and less than 5 times the illegal income; If there is no illegal income or the illegal income is less than 5,000 yuan, a fine of 5,000 yuan to 20,000 yuan shall be imposed.
In violation of the provisions of these regulations, the carrier knowingly transports medical waste, or the carrier and passengers transport medical waste in the same vehicle, and shall be punished in accordance with the provisions of the preceding paragraph.
Fifty-fourth medical and health institutions, medical waste centralized disposal units in violation of the provisions of this Ordinance, resulting in the spread of infectious diseases or environmental pollution accidents, causing damage to others, shall bear civil liability for compensation according to law.
Chapter VII Supplementary Provisions Article 55 The management of infectious, toxic and other hazardous wastes directly or indirectly generated in family planning technical services, medical scientific research, teaching, corpse examination and other related activities shall be implemented in accordance with these regulations.
Article 56 The management of medical wastes in military medical and health institutions shall be formulated by the competent health department of China People's Liberation Army with reference to these Regulations.