First, the elimination of the font size needs to be filed in the health department. After the successful filing, you can inquire on the link of the national disinfection products website. If the query is successful, it is a legal product with the font size removed.
Second, the filing process:
1. Determine whether the product is antibacterial or disinfection products.
2, to determine whether the product ingredients meet the national standards, remember not to add western medicine and hormone ingredients.
3. Draft product information according to the basic information of the product (as the basis for testing the font size).
4. Prepare samples for inspection (the period of eliminating font size is generally 3-4 months).
5. Record the safety assessment report.
6. Online declaration.
Category I disinfection products: advanced disinfectants and disinfectants, disinfectants and sterilizers for medical devices, skin/mucous membrane disinfectants, biological indicators and chemical indicators of sterilization effect; Category II disinfection products: Disinfectants, disinfection instruments, chemical indicators, packaging of sterilized articles with sterilization marks, and antibacterial (bacteriostatic) preparations other than the first category products. The responsible units in disinfection products need to conduct health and safety evaluation before the listing of Category I and Category II disinfection products.
What materials do autoclaves need for filing?
The testing and filing of pressure steam sterilizers need a professional and reliable third-party disinfection products testing and filing organization, which requires that testing institutions and units should have CMA qualification certification and pass the laboratory qualification certification, be able to test in strict accordance with the requirements of relevant disinfection products testing standards, and issue reliable CMA testing reports for health and safety evaluation reports.
Materials to be submitted for applying for CMA inspection and testing qualification:
(1) Application for Inspection and Testing Qualification Confirmation
(2) Typical test report (each type 1 copy)
(3) quality manual and program documents
(4) Business license (the business scope should include inspection and testing business, but not the scope of design, research and development, production and sales) (the approval document for the establishment of the laboratory is required for non-independent legal person laboratories)
(5) Power of attorney of the legal representative (when the independent legal laboratory and the legal representative do not participate in the laboratory management)
(6) Proof of the property right/use right of the fixed place (laboratory real estate license or house lease contract, and the house lease contract shall also submit the lessor's property right certificate)
(7) Records of internal audit and management review of management system (internal audit and management review can only be carried out after the management system is officially and effectively operated for 6 months)
(8) Certification documents for independent configuration of testing/calibration equipment (such as testing equipment invoices, equipment bidding documents, etc.). )
(9) Proof of labor relations between professional and technical personnel and management personnel (social security details and labor contracts confirmed by social security departments)
(10) qualification certificate of professional and technical personnel (technical director and authorized signatory should have the title of engineer or above or equivalent)
(1 1) Training and certification of inspection operators (personnel engaged in special inspection/calibration business need to provide corresponding qualification certificates, such as nondestructive testing personnel need to provide nondestructive testing certificates).
Where can I find the record report of font size elimination test of ozone sterilizer?
Ozone generator is a product without font size. For the inspection and filing of the product without the font size, it is necessary to handle the filing report in the third-party CMA certification and testing institution in disinfection products, and produce the inspection report with CMA certification. There are many third-party CMA institutions for font elimination test of ozone generator, such as Chinese Academy of Sciences. The filing and testing standards for font elimination detection and disinfection equipment of ozone generator are as follows: current national standard Technical Specification for Disinfection (2002 edition) current national standard safety and health standard for ultraviolet air sterilizers GB 28235-201current national standard safety and health standard for sodium hypochlorite generators GB 28233-201current. 0 1 1 Safety and Hygiene Requirements of Current National Standard Tableware Disinfection Cabinet GB 17988-2008 Safety and Hygiene Requirements of Current National Standard Tableware Disinfection Cabinet GB 17988-2008
How many liters of autoclave don't need to be filed?
Generally, small sterilization pressure cookers do not need the permission of special containers. Only pressure cookers over 25 liters need sterilization.
As long as the portable stainless steel steam sterilizer does not exceed 25L, do not register with the Quality Supervision Bureau. However, the pressure gauge must be sent to compulsory verification. You don't need any documents to send the verification, just go directly to the acceptance hall of the metrology institute.