(March 28, 2002 the Ministry of health released 27th) Chapter I General provisions article in order to strengthen the management of sterilization to prevent and control the spread of infectious diseases, safeguard human health, according to the People's Republic of China and its measures for the implementation of the relevant provisions of the law on prevention of infectious diseases, these measures are formulated.
    Second approach applies to medical and health institutions, sterilization services and disinfectant products production and business activities of units and individuals.
    Others need to disinfect the places and objects also apply to the measures for the administration.
    Article III Ministry of health responsible for disinfection and supervision nationwide.
    Railways, transportation, health authorities in accordance with these measures are responsible for the supervision and administration of the disinfection system.
    Chapter II hygiene requirements article fourth of disinfecting medical and health institutions shall set up disinfection and management organizations, make disinfection management system, implementation of the relevant norms, standards and regulations of the State, regularly carry out disinfection and sterilization efficacy testing.
    Article fifth Healthcare Agency staff should be trained in disinfection technology training, knowledge of disinfection and strict implementation of the disinfection system. Sixth used by health authorities into human tissue or sterile organs must meet the requirements of sterilization of medical supplies. Various injections, punctures, blood collection devices should be a person with a sterilization.
    Contact with the skin, mucous membranes to achieve disinfection of equipment and supplies required.
    Medical and health institutions shall, without delay after the use of disposable medical supplies used for treatment.
    Seventh medical and health institutions to buy disinfection products must establish and implement incoming inspection and acceptance system. Article eighth of medical and health institutions for environment, and shall comply with the relevant norms, standards and regulations of the State. Abandoned emission sewage, dirt should be carried out in accordance with the relevant provisions of the State harmless treatment.
    Transporting patients with infectious diseases and pollution vehicles, tools must be disinfected.
    Nineth medical and health institutions of infectious disease outbreaks, epidemics, and shall promptly report to the local administrative Department of public health, and to take effective disinfection measures.
    Tenth strip processing, sale, and transport of infectious diseases pathogen contamination or coming from an infected area may be contaminated with pathogens of infectious diseases skin, disinfection should be carried out.
    11th should be sound management system and implementation of disinfection in nurseries, indoor air, food (drink), towels, toys and other children's activity site and contact objects disinfected on a regular basis.
    12th rental units and personal clothing and wash clothing and related items and places should be disinfected.
    13th of pathogenic microorganism experiment unit should implement the management system, operating rules, experimental equipment, pollution items according to the regulations, such as disinfection, preventing the spread of infections and pathogenic micro-organisms in laboratory.
    14th funeral homes, Crematories and body contact items and transporting bodies should be disinfected in a timely manner.
    15th employs floating more than 200 employers, floating should be concentrated living place and disinfected on a regular basis.
    16th foci and disinfection should be implementing national relevant norms, standards and regulations.
    Article 17th places, food, drinking water, sterilization of blood products management, in accordance with the relevant provisions of laws and regulations.
    Chapter III production of disinfection products operating 18th disinfection products shall comply with the relevant national norms, standards and regulations.
    Article 19th disinfection products shall comply with the relevant national norms, standards and regulations, for the production of disinfection products should be tested, not qualified who is not the factory.
    Article 20th disinfectants, disinfection equipment, hygienic products and manufacturer of disposable medical supplies should be made after local provincial health license issued by the administrative departments of public health, before engaging in the production of disinfection products. 21st provincial health Administrative Department shall receive sterilized products production enterprise application made within one month from the date of approval of the decision.
    To meet the requirements of the disinfection and hygienic specifications of production enterprises, issued health permit does not meet the, were rejected, and explain the reasons.
    22nd disinfection products production enterprise of health license number format: (abbreviation of provinces, autonomous regions and municipalities), Wei Xiao certificate (certification year) XXXX number.
    Health permit production of disinfection products enterprises project into disinfectants, disinfection equipment, health supplies and disposable medical products.
    23rd disinfection products production enterprise health permit is valid for four years and reviewed on an annual basis. Disinfection and hygiene certificate before the expiry of the product manufacturer for three months, production enterprises shall apply to the issuing authority issue a health permit. Review meets the requirements, issue a new card.
    New health permit extension of the original number.
    24th site of disinfection products enterprises, or set up another branch (workshop), should be in accordance with this regulation to the seat of the production sites of the provincial health disinfection products enterprises permits from the Administrative Department of public health.
    Mark on product packaging site addresses should be the actual production, health permits, and their license number. 25th obtain a health permit disinfection products production enterprise changes its corporate name, legal representative, or the production category, shall apply to the issuing authority, agreed by the review and issue a new card.
    New health permit extension of the original number. Article 26th health supplies and disposable medical supplies in front of the market shall be filed with the provincial health Administrative Department.
    Record set by the Ministry of Health's hygiene products and disposable medical supplies for the record requested information management requirements. The provincial health administrative departments from the date of acceptance of the application to meet the requirements in the 15th, to record voucher. Filing number format: (abbreviation of provinces, autonomous regions and municipalities), Wei Xiao Zi (certification year) XXXX number.
    Not for the record, it shall explain the reasons.
    Record voucher valid throughout the country. The 27th article import health products and disposable medical supplies shall be filed with the Ministry of health record before entering the Chinese market for the first time. Record set by the Ministry of Health's hygiene products and disposable medical supplies for the record requested information management requirements.
    When necessary, the Ministry of health you can audit the manufacturer. The Ministry of health from the date of acceptance of the application to meet the requirements in the 15th, to record voucher. Filing number format: Wei Xiao (certification year) XXXX number.
    Not for the record, it shall explain the reasons.
    28th production of disinfectants and disinfection devices should be in accordance with the regulations issued by the Ministry of health made disinfectants, disinfection equipment and health permit.
    29th article production enterprise application disinfectant, and disinfection devices health license documents of approval program is: (a) production enterprise should by Ministry of health disinfection products declared and accepted provides of requirements, to location provincial health administrative sector proposed application, by provincial health administrative sector on its declared information and samples for trial; (ii) provincial health administrative sector since accepted of day up one months within completed on declared information integrity, and legitimacy and normative of review, review qualified of party can reported Ministry of health approval;
    (C) within four months from the date of receipt of notification of the Ministry of health on whether to approve the decision. Products approved by the Ministry of health, to disinfectants, disinfection equipment and health permit, approval number format: Wei Xiao Zi (year) XXXX number.
    Is not granted, it shall explain the reasons. Article 30th disinfectants, disinfection equipment applying for import health permit, an application shall be made directly to the Ministry of health, and disinfection in accordance with Ministry of health product application and admissibility requirements of the submitted material.
    When necessary, the Ministry of health to audit the manufacturer site. The Ministry of health shall, within four months from the date of acceptance of declaration made on whether to approve the decision. On the import permit, import of disinfectants, disinfection equipment and health permit, approval number format: Wei Xiao (year) XXXX number.
    Is not granted, it shall explain the reasons. 31st disinfectants, disinfection equipment health permit is valid for four years. Six months before the expiration date, manufacturer or agent shall, in accordance with Ministry of health disinfection products for imported products Declaration of admissibility requirements and issue a hygiene license documents that meet the requirements to apply for.
    Allowed to change health permit extension of the original approval number.
    Article 32nd buy disinfection products, should be obtained from the following valid documents: (a) copy of hygiene license for manufacturing enterprises, (ii) product filing certificate or copy of health permit.
    Copy of valid documents should be stamped with the seals of the original holder.
    33rd disinfection product naming, labelling (including manuals) shall comply with the relevant provisions of the Ministry of health.
    Product labels (including instructions) and advertisements must be true, not allowed or implied therapeutic effect on diseases.
    34th prohibits the production and operation of sterilization of the following products: (a) no health permit, production enterprise product record or certificate of hygiene license documents, (ii) products do not meet the requirements of hygienic quality.
    Fourth chapter 35th disinfection disinfection Service service agencies must make application to the provincial health administration, made the provincial health Administrative Department issuing health licenses before they can carry out sterilization services. Disinfection services health license number format: (abbreviation of provinces, autonomous regions and municipalities), Wei Xiao served certificate (certification year) XXXX number, valid for four years and reviewed on an annual basis. Three months before the expiration date, disinfection services shall apply to the issuing authority issue a health permit. Review meets the requirements, issue a new card.
    New health permit extension of the original number. 36th article disinfection service institutions should meet following requirements: (a) has meet national about specification, and standard and provides of disinfection and sterilization equipment; (ii) its disinfection and sterilization process and work environment must meet health requirements; (three) has can on disinfection and sterilization effect for detection of personnel and conditions, established since check system; (four) with ring oxygen ethane and ionization radiation of method for disinfection and sterilization of, its security and environmental protection, aspects of requirements by national about provides implementation;

    (E) using ethylene oxide and ionizing radiation disinfection service must go through the provincial health administrative departments of professional and technical training, to other disinfection methods in disinfection of service personnel must pass through the city divided into districts (ground) level health administrative departments at or above the Organization's professional and technical training, obtained the relevant qualification certificates before they can work.
    37th disinfection services institution may purchase and use not in accordance with this regulation of disinfectant products.
    Article 38th disinfection should be supervised by the Department of the local health service agencies.
    Fifth chapter supervision 39th article County above health administrative sector on disinfection work exercise following supervision management terms: (a) on about institutions, and places and items of disinfection work for supervision check; (ii) on disinfection products production enterprise implementation disinfection products production enterprise health specification situation for supervision check; (three) on disinfection products of health quality for supervision check; (four) on disinfection service institutions of disinfection service quality for supervision check; (five) on violation this approach of behavior take administrative control measures;
    (Vi) administrative penalties for violations of this approach.
    40th under any of the following circumstances, health administrative departments at or above the provincial level can have access to health permit review and file disinfection products for voucher: (a) questioned the authenticity of product formulation, manufacturing process, (ii) disinfection effect of product safety, challenged and (iii) product advertisements, labels (including instructions) being questioned. 41st disinfection product health permit holder shall, on receiving health administrative departments at or above the provincial level review notice within one month, in accordance with the notification of the requirement to submit materials.
    Over this period did not submit the relevant materials, as a waiver review, health administrative departments at or above the provincial level may be cancelled product health permit approval number or registration number. 42nd health administrative departments at or above the provincial level from the date it received to review all the materials needed, within one month, re-examine decisions should be made.
    Any of the following circumstances, cancellation of health license approval number or registration number: (a) tampering with the product name, formula, manufacturing process, (ii) disinfection effect of product safety, does not meet requirements; (c) the exaggerated publicity. Article 43rd disinfection product inspection bodies shall be identified by the health administrative departments at or above the provincial level.
    Not found, may not engage in disinfection product inspection.
    Product inspection certificate of inspection and evaluation reports, should be objective and realistic, in compliance with the relevant norms, standards and regulations.
    Test report of disinfection products issued by the inspection bodies, effective throughout the country. 44th issue a false inspection report or neglect is difficult to guarantee the disinfection products quality inspection agencies, by the health administrative departments at or above the provincial level shall be ordered to correct, and criticized serious, cancel a recognized qualification.
    Cancelled finds qualified inspection agencies may not reapply for identified within two years.
    Sixth chapter penalty provisions Disi、Wu、Liu、Qi、BA、jiutiao 45th medical and health institutions in violation of the measures, the local health administration departments at or above the county level shall order correction within, can be fined a maximum of 5000 Yuan and cause outbreaks of infectious diseases, may be fined a maximum of 5000 Yuan more than 20000.
    46th strip processing, sale, and transport of infectious diseases pathogen contamination or coming from an infected area may be contaminated with pathogens of infectious diseases of fur, not disinfected according to relevant regulations of the State shall be in accordance with the law on prevention of infectious diseases of 68th of the measures for the implementation of the relevant provisions are punished.
    47th disinfection products production and business operation entity in violation of these regulations 33rd, article 34, local health administrative departments at and above the county level shall be ordered to rectify, can be fined a maximum of 5000 Yuan and cause outbreaks of infectious disease, may be fined not more than 5000 Yuan more than 20000.
    48th article disinfection service institutions violation this approach provides, has following case one of of, by County above health administrative sector ordered its deadline corrected, can at 5000 Yuan following of fine; caused infection sex disease occurred of, can at 5000 Yuan above 20000 Yuan following of fine: (a) disinfection Hou of items not reached health standard and requirements of; (ii) not made health license engaged in disinfection service business of.
    Seventh chapter supplementary articles article 49th this way the meaning of the following terms: infectious diseases: diseases caused by microorganisms.
    Disinfection products including disinfectants, disinfection equipment (including bio-indicators, chemical indicator and sterile goods packaging), hygiene products and disposable medical supplies.
    Disinfection services: to provide the community with potentially contaminated objects and places, health supplies and disposable medical supplies for disinfection and sterilization services unit.
    Medical and health institutions: health care, disease control, blood collection and supply agencies and with the business activities of the same unit.
    50th article this way by the Ministry of health is responsible for the interpretation. 51st article of the rules take effect on July 1, 2002.
                                                      August 31, 1992 disinfection regulations promulgated by the Ministry of health repealed simultaneously.