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YY 0719.7-2011: Ophthalmic optics. Contact lens care products. Part 7: Biological evaluation test methods
YY/T 0719.7-2011 (Renamed from YY 0719.7-2011)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.7-2011
Ophthalmic optics - Contact lens care products -
Part 7: Biological evaluation test methods
ISSUED ON: DECEMBER 31, 2011
IMPLEMENTED ON: JUNE 01, 2013
Issued by: State Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Cytotoxicity test ... 5 
4 Skin irritation test ... 8 
5 Acute eye irritation test ... 9 
6 Acute oral toxicity ... 10 
7 Skin sensitization test ... 12 
8 Rabbit eye compatibility study test and determination of preservative intake
and release ... 13 
Appendix A (Informative) In vitro cytotoxicity test method ... 14 
Ophthalmic optics - Contact lens care products - Part
7: Biological evaluation test methods
1 Scope
This part of YY 0719 specifies the biological test methods for contact lens care
products.
This part applies to contact lens care products.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) is applicable to this standard.
GB/T 16886.1 Biological evaluation of medical devices--Part 1:Evaluation
and testing
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Test for in
vitro cytotoxicity
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity
GB/T 16886.11 Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity
GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials
GB/T 28538 Ophthalmic optics - Contact lenses and contact lenses care
products - Determination of biocompatibility by ocular study with rabbit eyes
GB/T 28539 Ophthalmic optics - Contact lenses and contact lens care
products - Guidelines for determination of preservative uptake and release
YY 0719.1 Ophthalmic optics - Contact lens care products - Part 1:
Vocabulary
YY 0719.2 Ophthalmic optics - Contact lens care products - Part 2:
the test solution.
3.6.2 For contact lens care products that indirectly contact human eyes (such
as hydrogen peroxide care solution), simulate actual use operations according
to the product's instruction manuals; take the product that ultimately contacts
the human body as the test solution.
3.7 Preparation before test
The cells that have been cultured for 48 h ~ 72 h with good morphology and
vigorous growth are made into cell suspension (trypsin, disodium edetate or
pancreatin + disodium edetate digestion solution can be used), to perform cell
count to determine the cell suspension's concentration; meanwhile prepare a
certain concentration of cell suspension according to the requirements of the
test method.
3.8 Test method - Agar diffusion method
3.8.1 Prepare a cell suspension of 1×105 cells/mL.
3.8.2 Add the cell suspension to a ϕ60 mm culture dish; each culture dish is 4.5
mL, a total of 6 culture dishes.
3.8.3 Put all culture dishes into a 5% CO2 incubator (containing 5% carbon
dioxide gas by volume, the same below), to culture it at (37 ± 1) °C saturated
humidity for 24 hours; the cells grow into a single layer.
3.8.4 Discard the original culture medium; add 4.5 mL of "agar medium" to each
culture dish. Culture in a CO2 incubator for about 30 minutes to make it solidify.
The agar medium is the mixture of double cell culture medium and 0.5% tissue
culture agar in equal amounts.
Note: After mixing and adding to the culture dish, it must not be solidified; at the same
time, avoid problems such as high temperature denaturation of proteins in the medium
or degradation of amino acids.
3.8.5 Add 4.5 mL of newly prepared neutral red active staining solution (or other
cell active staining solution) to the surface of the solidified agar; culture in the
dark at (37 ± 1) °C for 0.5 h; suck out the excess staining solution.
3.8.6 Use a filter membrane which has a diameter of 0.9 cm to draw 100 μL of
the test solution; gently place the filter on the surface of the agar; operate 2
dishes in parallel for each of the positive control group, negative control group
and test solution group.
3.8.7 Incubate in a 5% CO2 incubator at (37 ± 1) °C saturated humidity for 24 h
~ 48 h.
a) The name of the test product;
b) Production batch number or production date;
c) Preparation method of test solution;
d) Test medium, cell lines and negative, positive and other control
substances;
e) Test procedure;
f) Cell morphology description, measurement data and other conditions.
4 Skin irritation test
4.1 Purpose
This test evaluates the potential of contact lens care products to produce skin
irritation under test conditions.
Note 1: Based on animal welfare requirements, according to GB/T 16886.2, if the test
product has skin irritation, the eye irritation test is no longer carried out.
Note 2: If the manufacturer uses the same or similar contact lens care products
currently commercially available on the market, the eye irritation test can be performed
directly.
4.2 Main equipment and appliances
Animal balance, syringe.
4.3 Preparation of test animals
According to the provisions of GB/T 16886.10.
4.4 Preparation of test solution
4.4.1 For contact lens care products that directly contact human eyes (such as
eye wetting solution, multi-functional care solution), directly take the sample as
the test solution.
4.4.2 For contact lens care products that indirectly contact the eyes (such as
hydrogen peroxide care solution), simulate actual use operations according to
the product instructions; take the product that eventually contacts the human
body as the test solution.
4.5 Test procedure and result evaluation
hydrogen peroxide care solution), simulate actual use operations according to
the product instructions; take the product that eventually contacts the human
body as the test solution.
5.4 Test procedure and result evaluation
Operate and evaluate according to the acute exposure test method in GB/T
16886.10.
5.5 Test report
The following information shall be given in the test report:
a) The name of the test sample;
b) Production batch number or production date;
c) Description of the test animal;
d) Preparation of test solution;
e) Test procedure;
f) Observation records;
g) Evaluation of results.
6 Acute oral toxicity
6.1 Purpose
This test is to evaluate the oral toxicity potential of contact lens care products
in a single oral dose.
6.2 Main equipment and appliances
Syringe, gavage needle, animal balance.
6.3 Preparation of test animals
6.3.1 The test uses healthy, newborn mice, the same strain and the same
source, the female mice are non-pregnant, weighing 17 g ~ 23 g. It allows the
mice to adapt to the laboratory environment before the test.
6.3.2 Each group of tested mice uses 10 mice, half male and female. 5 mice of
the same sex are kept in each cage and marked.
6.4 Preparation of test solution
The following information shall be given in the test report:
a) The name of the test sample;
b) Production batch number or production date;
c) Description of the test an...