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GB 19192-2003: Hygienic requirement for contact lens care solution [including MODIFICATION 1]
GB 19192-2003
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 59
idt ISO/DIS 11980:1996
ISO/DIS 11981:1996
Hygienic requirement for contact lens care solution
ISSUED ON: JUNE 13, 2003
IMPLEMENTED ON: FEBRUARY 01, 2004
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of PRC
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Definition ... 4 
4 Technical requirements ... 6 
5 Test method ... 7 
6 Inspection rules ... 11 
7 Packaging, marking, instructions for use ... 12 
Appendix A (Normative) Test method of disinfection effect ... 13 
Appendix B (Normative) Test and evaluation method of cytotoxicity ... 17 
Appendix C (Normative) Test method of stability ... 20 
Appendix D (Normative) Neutralizer identification test ... 23 
Appendix E (Normative) Formulations of reagents and media ... 28 
Hygienic requirement for contact lens care solution
1 Scope
This standard specifies the definition, technical requirements, test methods,
inspection rules, packaging, marking, user instructions for the care solution of
contact lens (rigid lens and/or soft lens).
This standard applies to special care solutions for contact lenses.
2 Normative references
The provisions contained in the following standards constitute provisions of this
standard through quotation in this standard. At the time of publication, the
editions indicated were valid. All standards will be revised; all parties using this
standard shall explore the possibility of using the latest version of the following
standards.
GB 15979-2002 Hygienic standard for disposable sanitary products
ISO/DIS 11980:1996 Ophthalmic optics - Contact lenses - Ageing by
exposure to UV and visible radiation (in vitro method)
ISO/DIS 11981:1996 Ophthalmic optics - Contact lenses and contact lens
care products - Determination of physical compatibility of contact lens care
products with contact lenses
The Pharmacopoeia of the People’s Republic of China: Part 2 of the 1995
edition: "Clarity inspection method" and "Aseptic inspection method"
The Ministry of Health of the People’s Republic of China: "Disinfection
Technical Specifications" (Third Edition), Volume 1 "Experimental Technical
Specifications" (1999) "Disinfectant Toxicology Experimental Technology"
3 Definition
This standard uses the following definitions.
3.1
Contact lens care solution
The solution OR the soluble solid preparations which can be prepared into
solution for use, which is specifically used for contact lens care; has the
functions of cleaning, disinfecting, rinsing or preserving lenses, neutralizing
detergents or disinfectants; physically relieves (such as lubricating) the eye
discomfort, which is caused by contact lenses. It includes products, which
can directly or indirectly contact the eyeball, during use.
Contact lens care solutions can be divided into single-function type and
multi-function type. The single-function contact lens care solution is a
product, which has only one of the above-mentioned functions. The multi-
function contact lens care solution is a product, which has four functions of
cleaning, disinfection, rinsing, preservation, at the same time.
3.2
Multidose products
The product, whose smallest volume of care solution in the packaging
container can be used more than once.
3.3
Singledose products
The product, whose smallest volume of care solution in the packaging
container can only be used once.
3.4
Cleaning
Treatment to remove protein, organic matter, dirt, etc.
3.5
Disinfection
The treatment of killing OR removing pathogenic microorganisms, to achieve
harmlessness.
3.6
Neutralization
Treatments that eliminate the inhibitory/bactericidal activity of disinfectants
and/or antimicrobial agents.
3.7
c - The molar concentration of potassium permanganate standard solution.
5.1.6 Physical compatibility with lenses
When tested according to the method of ISO/DIS 11981, it shall meet the
corresponding requirements in Table 1.
5.2 Microbial indicators
5.2.1 Processing of solid sample
Accurately weigh 2.000 g of specimen. Put it into 20.0 mL of 0.03 mol/L
phosphate buffer solution (PBS) (if the product contains antibacterial
ingredients, use a neutralizer instead of PBS). Completely dissolve it. Take
sample. Carry out testing, according to the following method.
5.2.2 Viable bacteria count
Take 1.0 mL of sample solution, to inoculate nutrient agar medium. Inoculate
two plates in parallel in each tube. Incubate it at 35 °C ~ 37 °C for 48 h.
Calculate the average number of colonies on the plate, according to formula (2).
It shall meet the corresponding requirements in Table 1.
Viable bacteria count (cfu/g) = Average number of colonies on the plate x
10 ………………………... (2)
5.2.3 Pathogenic bacteria
Use the method in Appendix A of GB 15979-1995 "Hygienic standard for
disposable sanitary products", to carry out testing for the Staphylococcus
aureus, Pseudomonas aeruginosa, Escherichia coli. It shall meet the
corresponding requirements in Table 1.
Note 1: The neutralizer, which is used in this test, must pass the suspension
quantitative neutralizer qualification test, which is specified in Appendix D (normative).
Note 2: If it can’t find a suitable neutralizer, it can process the sample solution, in
accordance with the "Sterile inspection method" and "Membrane filtration method" of
the Pharmacopoeia of the People's Republic of China (Part 2 of the 1995 edition). The
film is directly inoculated with the corresponding culture medium for testing.
5.2.4 Sterility inspection
It is tested according to the "Sterile inspection method" of the Pharmacopoeia
of the People's Republic of China (Part 2 of the 1995 edition) (if the product
contains antibacterial ingredients, it must be treated with membrane filtration
first). It shall meet the corresponding requirements in Table 1.
5.3 Disinfection effect index
See Appendix A (normative), which shall meet the corresponding requirements
in Table 1.
5.4 Safety indicators
5.4.1 Acute oral toxicity test, mutagenicity test, skin irritation test, eye irritation
test, skin allergic reaction test
It is tested, according to the "Disinfectant Toxicology Experimental Technology",
in the volume 1 "Experimental Technical Specifications" (1999), of the
"Disinfection Technical Specifications" (third edition) of the Ministry of Health of
the People's Republic of China. It shall meet the corresponding requirements
in Table 1.
5.4.2 Cytotoxicity test
See appendix B (normative), which shall meet the corresponding requirements
in Table 1.
5.5 Stability Index
See appendix C (normative), which shall meet the corresponding requirements
in Table 1.
5.6 Clinical tests
5.6.1 Products which must be subject to clinical tests:
a) Various care solutions containing new ingredients: It requires a 3-month
clinical tests with 60 subjects;
b) Various care solutions whose active ingredients are higher than the
concentration of the products on the market: It requires a 1-month clinical
trial with 30 subjects;
c) Intraocular solutions whose active ingredients are lower than those of the
marketed products AND care solutions which have cleaning, disinfection
or neutralization effects: It requires a 1-month clinical trial with 30 subjects.
5.6.2 Test control: It mu...