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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 must set paired control, which is equivalent to the subject.
5.6.3 Test method: When tested according to the method of ISO/DIS 11980, it
shall meet the corresponding requirements in Table 1.
7 Packaging, marking, instructions for use
7.1 Packaging
7.1.1 Packaging materials that are in direct contact with the contact lens care
solution: It shall be safe and harmless; it shall not affect the hygienic quality of
the product within the valid date.
7.1.2 The transportation and packaging of contact lens care products: It shall
be able to protect the product from damage, during transportation and storage.
7.2 Marking
7.2.1 Sales packaging mark: In Chinese, it shall indicate the product name,
main active ingredients, net content, production batch number, valid date or
guarantee date, manufacturer's name and address, approval document number,
implemented standard number, as well as necessary precautions. For imported
products, it shall also be marked with the name and address of the distributor.
7.2.2 Transport packaging mark: In Chinese, it shall indicate the product name,
specification and quantity, production batch number, valid date or guarantee
date, manufacturer name and address, approval document number,
implemented standard number, as well as necessary precautions. For imported
products, it shall also be marked with the name and address of the distributor.
7.3 Instructions for use
7.3.1 Each sales package shall be accompanied by instructions for use.
7.3.2 Instructions for use must clearly indicate the following content, in Chinese:
product name and dosage form, main active ingredients and content,
performance, scope of application and contraindications, detailed use methods
and procedures, adverse reactions or side effects, storage conditions, valid
date or guarantee date, as well as precautions.
7.3.3 For the instructions for use of the singledose product, it shall state ?€?Use
only once?€?. For the instructions for use of multidose products, it shall state ?€?The
container must be closed, immediately after each use?€?, as well as the discard
date.
Appendix A
(Normative)
Test method of disinfection effect
A1 Purpose
Used to determine whether the contact lens care solution has disinfection
function.
A2 Test method
A2.1 Suspension quantitative sterilization test
A2.1.1 Test microorganisms
a) Bacteria: Escherichia coli (ATCC 8739 or 8099)
Staphylococcus aureus (ATCC 6538)
Pseudomonas aeruginosa (ATCC 9027)
b) Yeast: Candida albicans (ATCC 10231)
c) Mold: Fusarium Solanaceae (ATCC 36031)
A2.1.2 Operating procedures
A2.1.2.1 Take a fresh slant culture (18 h ~ 24 h) of the nutrient agar of the 3 ~
14th generation of strains. Use 0.03 mol/L phosphate buffered saline (PBS) to
rinse it. Dilute it to bacterial suspension, which has a bacterial content of 1x107
cfu/mL ~ 1x108 cfu/mL.
A2.1.2.2 Pipette 10.0 mL, respectively, from the three batches of specimens,
into three sterile test tubes. Place in a water bath, at 20 ??C ~ 25 ??C, for 5 min.
A2.1.2.3 Add 0.1 mL of bacterial suspension, to the test tube, to make the final
bacterial content at 1x105 cfu/mL ~ 1x106 cfu/mL. Mix well. Start timekeeping.
A2.1.2.4 At four different action times (25%, 50%, 75%, 100% of the
recommended minimum disinfection time), respectively take 1.0 mL of the
bacterial drug mixture; transfer it into 9.0 mL of the neutralizer. Mix well.
A2.1.2.5 After 10 minutes of neutralization, pipette 1.0 mL of the stock solution
or 10-fold serial dilution. Respectively inoculate it with nutrient agar medium
(bacteria), Sandburg's agar medium (yeast) or potato dextrose agar medium
Appendix B
(Normative)
Test and evaluation method of cytotoxicity
B1 Purpose
A certain amount of test substance is added to cell culture medium, to culture
cells. The potential toxicity of the care solution on mammalian cells is evaluated,
by its influence on cell growth and proliferation.
B2 Reagents
a) Positive control: 64 g/L phenol solution.
b) Negative control: The following medium.
c) Cell strain: It is recommended to use L-929 cells (mouse fibroblasts). The
cells used for the test are cells that grow vigorously at regeneration for 48
h ~ 72 h.
d) Medium: Eagle's MEN is added with 10% calf serum;
e) Phosphate buffered saline (PBS).
Calcium-magnesium-free phosphate buffer: 100.0 mL
Phenol red solution: 10.0 mL
200 g/L magnesium chloride solution: 0.5 mL
100 g/L calcium chloride solution: 1.0 mL
Water: Add to 1000 mL
B3 Test procedure
B3.1 Preparation of cell suspension: Use the cell culture medium to prepare
40000 cells/mL cell suspension. Distribute it in test tubes (1 mL/tube), including
13 tubes for negative control group (1 spare tube) AND 10 tubes for material
group (1 spare tube). If necessary, set up 3 tubes of the positive control group;
place them in a 37 ??C constant temperature incubator, to culture it for 24 hours.
B3.2 Preparation of the test substance: Add 0.2 mL of the test substance, into
the cell culture solution. Incubate it at 37 ??C for 24 h.
B3.3 Test solution exchange: After 24 hours, discard the original culture solution
in each tube. For the negative control group, 9 tubes are exchanged with fresh
culture solution. For the positive control group, use cell culture solution which
contains 64 g/L phenol for exchange. For the test substance group, use the
fresh culture solution, which contains the test solution, at the volume fraction of
50%, for exchange. Count the cells in three negative control tubes. Keep the
others at 37 ??C, to continue the culture.
B3.4 Cell count and absorbance determination
B3.4.1 Perform cell count or absorbance determination, on each of the three
tubes of the control group and the test group, at the 2nd, 4th, 7th days, to
determine the degree of cell proliferation.
B3.4.2 Cell counting method: Use the crystal violet, which contains the sodium
citrate, to stain it. Make counting for the hemocytometer, under a microscope.
The upper and lower limits shall not exceed 10%; otherwise, the count shall be
repeated.
B3.4.3 Spectrophotometer absorbance method (arbitration method): Discard
the original cell culture solution. Use PBS to rinse it. Use the formaldehyde
solution, which has a volume fraction of 10%, to fix it for 10 min. Use water to
wash it for (2 ~ 3) times. Add 1.5 mL of the 5 g/L crystal violet, to stain it for 3
min. Use water to wash it for (2 ~ 3) times. Add 3.5 mL of the 10 g/L sodium
lauryl sulfate. Use a spectrophotometer, to measure the absorbance, at a ...