To do poliovirus killing test testing organizations, the Ministry of Health has relevant provisions, China Science and Technology Testing to obtain the appropriate disinfection product testing CMA qualification, and through the poliovirus inactivation test, Aspergillus niger and Mycobacterium avium killing effect of the test project to increase the identification. Ministry of Health on disinfection product testing organizations to carry out poliovirus inactivation test, Aspergillus niger and Mycobacterium avium killing effect of the test project to determine the provisions:
A, laboratory conditions
Declare that the laboratory should be through the measurement of accreditation, and as soon as possible to carry out the project additions. One of the declaration of poliovirus inactivation test project, need to have an independent virus laboratory, area ≥ 30m2; declaration of Aspergillus niger killing test and mycobacterium killing test project, need to have an independent microbiology laboratory, area ≥ 15m2.
Two, instrumentation and equipment conditions
(a) declaration of the poliovirus inactivation test project, need to have the following equipment:
Water bath 1 unit
Biological safety cabinet 1 unit
High-speed centrifuge 1 unit
Oscillator 1 unit
Carbon dioxide incubator 1 unit
Inverted microscope 1 unit
Ultra-low-temperature refrigerator (-80 ℃) 1 unit
High-speed cryo-centrifuge 1 unit
Liquid nitrogen tank 2 pcs.
(2) Declaring the items of Aspergillus niger killing test and Mycobacterium species killing test, the following equipment is required:
Temperature oven (30~37℃) 2 sets
Refrigerator 2 sets
Negative-pressure biosafety cabinet 1 set
Ordinary centrifuge 1 set
Bacterial turbidity counter 1 set
Oscillator 1 set
Vacuum pump 1
Biological microscope 1
Three, personnel requirements
(A) the basic requirements
1, the applicant testing organization should apply for testing organizations should be compatible with the project of the organization's management, technology and quality control personnel;
2, the relevant personnel should be familiar with the relevant laws and regulations and documents, as well as the unit's quality manual of the relevant Provisions;
3, the professional staff should be consistent with the application of the test project, the person in charge of technology should be proficient in this professional business;
4, the inspection agency should have a personnel training program, and constantly improve the level of professional knowledge and skills of the personnel concerned;
5, all types of technical personnel should be examined, and those who have passed the test are issued with a certificate of competence. All types of personnel should be licensed.
(B) specific requirements
1, the technical head of the test department should be deputy senior or above, and have more than 3 years of professional experience in disinfection;
2, calibration (auditing) personnel should have intermediate or above, with more than 3 years of professional experience in disinfection, and after the assessment of the qualification;
3, the inspection staff should have secondary education and have some professional experience in disinfection science, after special training. Application for poliovirus inactivation test project inspectors not less than two people;
4, quality control personnel should be deputy senior or above technical title, and more than three years of professional experience in disinfection.
Four, the application process
Provincial testing organizations should be the provincial health administrative departments after the initial examination, before the Ministry of Health to submit a written application, the Ministry of Health directly to the Ministry of written applications for testing organizations.
V. Recognition of the procedure
The corresponding administrative department of health according to the application of the test agency to apply for the test project organization set up an audit team. Audit group is generally composed of 3-5 experts in related fields. Audit group in accordance with the following procedures for the audit work:
1. Review the declaration materials;
2. On-site to listen to a brief introduction to the testing organization, and ask questions on the issue;
3. On-site inspection of the laboratory and relevant records and information.