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YY 0719.7-2011 English PDF (YY0719.7-2011)

YY 0719.7-2011 English PDF (YY0719.7-2011)

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YY 0719.7-2011: Ophthalmic optics. Contact lens care products. Part 7: Biological evaluation test methods

This part of YY 0719 specifies the biological test methods for contact lens care products. This part applies to contact lens care products.
YY/T 0719.7-2011 (Renamed from YY 0719.7-2011)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE 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 ??60 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 ??L 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 animal;
d) Preparation of test solution;
e) Test procedure;
f) Observation records;
g) Evaluation of results.
7 Skin sensitization test
7.1 Purpose
In this test, the test solution of the contact lens care product is contacted with the skin of the guinea pig, to evaluate the potential of the contact lens care product to cause skin sensitization under the test conditions.
7.2 Reagents
Sodium chloride injection with a mass concentration of 9 g/L,
dinitrochlorobenzene (DNCB), sodium lauryl sulfate, Freund's complete
adjuvant.
7.3 Main equipment and appliances
Pressure steam sterilizer, electric razor, syringe, animal balance.
7.4 Preparation of test animals
According to the provisions of GB/T 16886.10.
7.5 Control sample
Sodium chloride injection with a mass concentration of 9 g/L.
7.6 Preparation of test solution
7.6.1 For contact lens care products that directly contact human eyes (such as eye wetting solution, multi-functional care solution), directly take a sample as the test solution.

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