YY/T 0719.5-2022 (YY/T 0719.5-2009) PDF English
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Ophthalmic optics - Contact lens care products - Part 5: Determination of physical compatibility of contact lens care products with contact lenses
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Ophthalmic optics. Contact lens care products. Part 5: Determination of physical compatibility of contact lens care products with contact lenses [YY/T 0719.5-2009]
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YY/T 0719.5-2009: ---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0719.5-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Ophthalmic optics - Contact lens care products - Part
5: Determination of physical compatibility of contact
lens care products with contact lenses
(ISO 11981:1999:2005 Ophthalmic optics - Contact lens care products - Part
5: Determination of physical compatibility of contact lens care products with
contact lenses, MOD)
ISSUED ON: JUNE 16, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Principle ... 6
5 Choice of test lens ... 8
6 Steps ... 8
7 Test report ... 10
Ophthalmic optics - Contact lens care products - Part
5: Determination of physical compatibility of contact
lens care products with contact lenses
1 Scope
This part of YY 0719 gives the general steps and performance requirements for
determination of physical compatibility of contact lens care products with
contact lenses, determining whether the observed lens changes are reversible.
2 Normative references
The provisions in following documents become the provisions of this part
through reference in this part of YY 0719. For the dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this part; however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
YY 0719.1-2009 Ophthalmic optics - Contact lens care products - Part 1:
Vocabulary
ISO 18369-1:2006 Ophthalmic optics - Contact lenses - Part 1: Vocabulary,
classification system and recommendations for labelling specifications
ISO 18369-2:2006 Ophthalmic optics - Contact lenses - Part 2: Tolerance
ISO 18369-3:2006 Ophthalmic optics - Contact lenses - Part 3: Test methods
3 Terms and definitions
The following terms and definitions apply to this part of YY 0719.
3.1
Cycle
According to the instructions or recommendations provided by the contact
lens care product manufacturer, a series of care steps performed during the
UVB transmittance (τUVB) < 1% (λV).
3.8
Class 2
The contact lens class whose UVA transmittance (τUVA) < 50% (λV) and
UVB transmittance (τUVB) < 5% (λV).
3.9
Cosmetic contact lens
A contact lens designed to change or decorate the appearance of the eyes.
Note: Cosmetic contact lenses can be used for special medical purposes.
4 Principle
4.1 Measurement of changes in contact lens characteristics (refer to the
flowchart as shown in Figure 1)
4.1.1 Before the cycle operation, place the contact lens in a standard salt
solution to equilibrate for at least 15 minutes or until the parameters of the
contact lens are stable.
Note: The equilibration time of some hydrogel contact lenses can take up to 24 h.
4.1.2 The cyclic operation of the contact lens shall simulate the steps in the
instruction manual provided by the test product manufacturer.
4.1.3 Within the allowable contact time range, the cycle shall be carried out
under the most unfavorable conditions.
4.1.4 Before and after the cycle operation, the designated physical parameters
of the contact lens (see Table 1) shall be measured to determine their changes.
The changes shall be evaluated according to the technical indicators of the
finished product provided by the manufacturer and the technical indicators and
tolerances as specified in GB 11417.
Note 1: When testing a contact lens care product, a typical material within the
applicable scope of the product must be selected.
Note 2: During the test cycle operation, it is recommended to check the parameter
changes of contact lens during the cycle operation.
4.2.1 Only when the tested contact lens care product is according to the test
method of 4.1, the characteristics change of contact lens beyond the technical
indicators of finished product as provided by the manufacturer and the technical
indicators and tolerances as specified in GB 11417, this method is used.
4.2.2 Rebalance the measured lenses in the test group in the standard salt
solution; re-measure them, to distinguish reversible and irreversible changes.
4.2.3 According to the technical indicators of finished product provided by the
manufacturer and the technical indicators and tolerances specified in GB 11417,
evaluate the contact lens parameters measured in the standard salt solution.
Note: For some types of contact lens materials, such as ionic materials, the ion
concentration of the standard salt solution may affect its parameters (as shown on the
label).
5 Choice of test lens
5.1 It is required to select an appropriate number of test lenses and control
groups (if necessary) for each type of contact lens material selected. The
average result of each test group shall be obtained on the basis of no less than
10 tablets.
5.2 The contact lens test material group shall represent the type of contact lens
for which the care product is applicable. Contact lens materials are as described
in ISO 18369-1.
Note 1: Considering the current reports on the incompatibility of silicone-containing
hydrogel lenses, it is recommended to conduct a separate compatibility test for this
type of material.
Note 2: Among at least 10 lenses in each group used in this test, there shall be lenses
with extreme vertex power.
6 Steps
6.1 Test method for testing characteristic changes in contact lens
6.1.1 Record the characteristics and treatment scheme of the contact lens to
be tested in detail. The record shall include the test method, order of use,
method of contact lens care products.
6.1.2 For the contact lens care products that need to be used daily, perform 30
cycles of each selected material.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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