This standard specifies the terms and definitions, technical requirements, test methods, inspection rules, and packaging, labeling and instructions for use of contact lens care solutions. This standard applies to contact lens care solutions. GB 19192-2003 Hygienic requirements for contact lens care solutions GB19192-2003 standard download decompression password: www.bzxz.net

KN 11.040.0
National Standard of the People's Republic of China
GB19192—2003
idtI0/DIS11980.1996
IS0/DIS 11981:1996
Hygiene requirements for contact lens care solutions
Hrgienic requirements for conlac1lenscaresolution
2003-06-13issued
People's Republic of China
General Administration of Quality Supervision, Inspection and Quarantine
2004-02-01implemented
GR19192-20C3
According to the service environment management: the main quality is to connect the system to the partner's Teng energy: the approval of the People's Republic of China's infectious disease prevention and control law, the implementation measures of the Chinese disease prevention and control law and the elimination rate management measures, special gas determination of this standard difficult. This standard can be used in accordance with IS0/DS11581:35S/1198:1956 and is based on the principles, test methods and evaluation criteria of international standards: light selection should be based on the requirements of my country's H development status, test methods and culture methods, and the use of ISO/DS11581:35S/1198:1956. This standard (except for the disinfection effect on the main fungi of Solanaceae) is mandatory and has The remaining chapters are for the purpose of combining this standard. The Ministry of Health of the People's Republic of China proposed this standard. The Shanghai Municipal Center for Disease Control and Prevention drafted it, Suzhou Sinochem Pharmaceutical Co., Ltd., Beijing Boshanglun Contact Lens Care Products Co., Ltd., and Yinli Pharmaceutical Co., Ltd. The main drafters of this standard are: Shuo Qi, He Jingyao, Shen Weijian, You Qihe, Shi Caihao, Sang Shang, Sun Xianzhi, 1 Scope
National Standard of the People's Republic of China
Hygienic requirements for contact lens care solutions
Hygienic reyuirement tur eunlaetlens cure sulutin
Headquarters B19192—2003
/11980:199
IS0/DIS31981:1996
This standard specifies the meaning, technical requirements, test methods, inspection rules and packaging, marking and instructions for use of invisible lenses (rigid and/or non-invasive lenses).
This standard certifies the use of special micro-protection products for invisible lenses. 2 References to comprehensive standards
The provisions contained in the following standards are used in this standard and constitute the provisions of this standard. When this standard is published, the versions shown are valid and all standards will be revised: All parties to this standard should use the latest version of the following standards to certify. G35930 (12 Disposable Weilan Monthly Product Health Management S0/IS119: 1996 Optical instruments and optical materials - Spectacles and basic care products - Clinical research guidance 1S0)/L>[511931: 1996 Optical instruments and optical materials - Spectacles and basic care products - Physical and compatibility test methods for hidden eye environments and their care products Ministry of Health of the People's Republic of China 1st edition \ Sterility inspection method "and" sterility inspection method "Ministry of Health of the People's Republic of China Sterility Technical Specifications First Edition First Part of the First Collection Technical Specifications (1%5) \ Disinfectants This standard adopts the following definition: 3.1 Invisible contact lens care products are specially used for contact lens care, which have cleaning, disinfection, rinsing components, active ingredients, and liquid ingredients that can be formulated into a removable solid preparation for use in contact lenses (such as lubricating contact lenses to relieve eye discomfort, etc.), including products that can be directly or non-point-applied to the eyes when used. Contact lens care products are divided into single-function and multi-function types. Single-function contact lens care products The system is a product that has only one function, the multifunctional mirror cleaning system only has the function of passing through the barrier, disinfection, flushing, and preservation of the product. 3.2 Multiple bone products mmidosearoduct products The amount of care solution in the small packaging container can be used more than times: 33gingedacprducta
The amount of care solution in the smallest packaging container can only be used once. 3.4 Cleaningcleaning
Removal of protein pressure, Kaifa, dirt, etc. 3.5 Disinfection| |tt||Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on 2003-D6-13 and implemented on 2004-02-C1
CR19192-2CC3
Kill or eliminate pathogenic microorganisms to achieve harmless treatment. 3.E-neutralizing agent before brewing tea, 3.Effective ingredients:
The product has cleaning, detoxification, neutralization and other functions. 3.The shelf life of the product is 3. aulc
The maximum credit period of the product after opening is 3.9 Validity period valintdate
Since the month of production, the unopened product with the functions of cleaning, silencing, neutralization, etc. can maintain the above mentioned functions for a long effective period of 3.10 Warranty period giiarmlale
Since the month of production, the product without the above mentioned functions can maintain the minimum effective ingredient content for a long period of 3 months. 4
Technical requirements
The technical requirements of the contact lens protective liquid should meet the requirements in 1, table: Technical requirements of invisible filter
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used for the main said place before, the mirror ratio of the object reverse safety environment out
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no authenticity or propagation
report mountain finished product original flow and the same state finished product use liquid ancient connection and that product original oil injection long
interconnection! : The product that you want to use has a certificate of use. Products with excessive chemical ingredients. Independent connection and unique product origin. Not a domestic product. Products that are not really mentioned. Products that are made with limited conditions. Products that can be sold in season. Existing products. You can feel the skin changes. Products that are determined by the three. After the contract, the product is monitored. GL19192—2003. Intended use. No intention. No successor. Product standard. Medical validity period. Shelf life. Products will be limited by the law to make the date
No adverse reactions
xEffective flight chemical division: Use the current 5 test methods of the mountain and after-products
According to the product taste reduction or the product opened by the bottle
Multiple medical products
Contains new ingredients: or the product with different concentrations of effective ingredients in the market
Randomly pick three batches of small-volume products for testing, with a batch number of at least three pieces, one of the three liters is tested, half of the time is tested, one egg sample, 5.1 Chemical indicators
5.1.1 Appearance
Chinese Pharmacopoeia (13th Edition: Ministry of Health) \ Barrier Treatment Institute Purchase Inspection Method "Test, should meet the corresponding requirements of No 1: 5. 1.2pH
Take 2mL, and make a determination at a temperature of ±1°C. The corresponding requirements in the table are met. 5.1.3 The test results are measured with a suitable pressure gauge, and the water or the calibrated value is used as the authorization. The average of three readings is the test result. The results meet the requirements in Table 1. 5.1.4 The content of active ingredients is determined by the national standard of the People's Republic of China, the National Standard of the People's Republic of China, and the industry standard. The average reading of the sample is three times, and the price and the price meet the corresponding requirements in the table. 5.1.5. After the mouse is deionized water, the residual scene
will be treated according to the method specified in the product specification for the time specified in the book. After neutralization, 5.m of the solution is added to the flask, and 15mT of benzene is added with 2nn/. high-pressure springs to mark the liquid. Titrate steadily until the pink color is maintained for 1. At the same time, the air is allowed to flow. Calculate the residual hydrogen peroxide according to (1). This should meet the requirements in Table 1.
Io(If the product contains inhibitors, use neutralizer instead of BS), take samples after full decomposition and conduct the above test. 5.2.2 Activity function
Take 1.0ml of sample solution and take nutrient solution. Each tube is parallelly calibrated for 31~48h. Calculate the average number of drops according to formula 21, which shall meet the corresponding requirements in the relevant table 1. Special figure i number (efu) plate average number of drops 1
5.2.3 Pathogens
According to the method in the attachment A of GB179199 for external use of sanitary products, the test of G. aureus, Escherichia coli, and Escherichia coli shall be carried out, which shall meet the corresponding requirements in Table 1. 1. This test must pass the method specified in the standard. Note: We do not replace the agent in the People's Republic of China. The sample with no "hidden" content in the first edition shall be tested according to the relevant information. 5.2.4 Bacteria inspection
According to the second edition of the People's Republic of China (1935) \Bacteria inspection method\Test the inhibition of the product, which must be treated by the frequency filtration method), and shall meet the corresponding requirements in Table 1. 5.3 Disinfection effect index
See the Appendix A (Standard), and shall meet the requirements in Table 1. 5.4 Safety index
5.4.1 Acute oral test, or mutation test, skin irritation test, oral irritation test, skin allergy test according to the experimental technical specifications of the People's Republic of China (1999) \Disinfection experimental technology\test, shall meet the corresponding requirements in Table 1, 5.4.2 Cytotoxicity test
See the Appendix (Appendix to the standard), should comply with the corresponding requirements in Table 1, 5.5 Qualitative indicators
See Appendix for the reduction list) + should comply with the corresponding requirements in Requirement 1 5.6 Clinical trials
5.6. Products that require clinical testing:
a) Nursing solutions with new ingredients: a clinical trial with 65 subjects for 8 months is required; b) Nursing solutions with ingredients above the product concentration standard: a clinical trial with 30 subjects for 1 month is required;) Products with efficacy lower than the original concentration of products in the industry and new products that will be cleared, eliminated from the market or in the future: a clinical trial with 30 subjects for 1 month is required. 5,6,2 Clinical trials must be carried out immediately or with the corresponding laboratory standards. 5.6.3 The test method must be reported in accordance with the 1S0/131S11650 method, and must comply with the corresponding laboratory standards. 6.1 Inspection rules for pine granules, including the inspection items before delivery, such as external inspection, H. penetrating tablets, active ingredient content, number of active ingredients, and sterility inspection of pathogenic bacteria. 6.2 Regular inspections, regular inspections, full inspections every year, disinfection inspections every two years, stability inspections every year. 6.3 Type inspections, type inspections, including all the technical requirements of the standard, should be carried out in the following cases. New products; when there are major changes in raw materials, processes, and specifications that may affect product performance: GB19192--2003, production can be stopped when the health department proposes to carry out type inspections. 6.4 Change test schedule, heat treatment test, etc. .41 The first new nursing care product produced in my country or imported for the first time according to domestic and foreign literature reports: must be tested for government investment. 6.4.2 The nursing care product produced by our country shall be approved for production by our country, and two test results shall be conducted.
6.4.3 The similar products of domestically produced control liquid shall be tested less frequently. 6.4.4 Regular inspection and type inspection: at least one test result shall be conducted: 7 Packaging, marking and instructions for use
7.1 Packaging
2.1.1 The packaging materials of the eye care liquid that come into direct contact with the eye care liquid shall be safe and harmless, and shall not affect the quality of the product during the effective period. 7.1.2 The packaging of the eye care product shall protect the product from damage during storage. 7.2 Marking
7.2. The product packaging shall bear the product name, specification and quantity, production number, validity period or warranty period, name and address of the importer, approval number, implementation standard number, and necessary instructions for use and notes. Imported products shall also be marked with the name and address of the importer:
7.2.2 Legal packaging marking: The product name, specification and quantity, production number, validity period or warranty period, name and address of the manufacturer and consumer, approval number, implementation standard number, and necessary notes shall be marked in Chinese. Imported products shall also be marked with the name and address of the distributor. 7.3 Instructions for use
7.3.1 Each sales package shall contain instructions for use. 3.2 Instructions for use: The product name and dosage form, main active ingredients and content, performance specifications and prohibitions, detailed instructions for use and steps, adverse reactions or effects, expiration date or shelf life, and precautions. 3.3 The product's usage limit should be clearly stated. The maximum amount of use should be stated in the product declaration. The container must be closed immediately after use. The disposal period should also be marked.
GB19192—2003
Tender request)
Test method for disinfection effect
State 10 Determine whether the invisible mirror expansion liquid is a disinfectant. 2 Test method
A2.1 Total wave sterilization test
Net 2.1.1 Test item
) Escherichia coli (ATCC8731 or)
Golden yellow S. cerevisiae
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