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YY 0719.5-2009: 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]
YY 0719.5-2009
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]
ICS 11.040.70
C40
People's Republic of China Pharmaceutical Industry Standards
Ophthalmic optical contact lens care products
Part 5.Contact lenses and contact lens care products
Determination of physical compatibility
(ISO 111981.1999.2005Ophthalmics-Contactlensand
controllenscare procedures-Determinationofphisicalcompatibilityof
Controllinkscareproductswithcontestlines, MOD)
Issued on.2009-06-16 Implementation of.2010-12-01
Issued by the State Food and Drug Administration
Preface
YY 0719 "Ophthalmic Optical Contact Lens Care Products" is divided into 7 parts.
---Part 1.Terminology;
---Part 2.Basic requirements;
---Part 3.Microbiological requirements and test methods and contact lens care system;
---Part 4.Antimicrobial antiseptic effectiveness test and guidelines for determining the date of discarding;
---Part 5.Determination of the physical compatibility of contact lenses and contact lens care products;
---Part 6.Guidelines for determination of validity period;
---Part 7.Biological evaluation test methods.
This part is part 5 of the YY 0719 standard.
This part is revised and adopted ISO 11981.1999+Cor1.2005 "Ophthalmic Optical Contact Lenses and Contact Lens Care Products Contact Lenses
Determination of physical compatibility with contact lens care products.
Differences between this part and ISO 11981.
1) Added the definition of contact lens terms related to the content of this section;
2) In the index reference documents, the obsolete standards are deleted and changed to the currently effective standards.
This part is proposed and managed by the National Technical Subcommittee on Medical Optics and Instrumentation (SACTC103/SC1).
Drafting organization of this section. Hangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
The main drafters of this section. Wen Yan, Jia Xiaohang, He Tao, Qi Weiming, Lu Xiaochun.
Ophthalmic optical contact lens care products
Part 5.Contact lenses and contact lens care products
Determination of physical compatibility
1 Scope
This part of YY 0719 gives the general steps and performance requirements for evaluating the physical compatibility of contact lenses and contact lens care products, and
Determine whether the observed lens changes are reversible.
2 Normative references
The clauses in the following documents become clauses of this part through the reference of YY 0719 in this part. For all dated reference documents,
All subsequent amendments (excluding errata content) or revisions do not apply to this section, however, it is encouraged to reach an agreement based on this section
The parties to study whether the latest versions of these documents can be used. For undated reference documents, the latest version is applicable to this section.
YY 0719.1-2009 Ophthalmic optical contact lens care products Part 1.Terminology
ISO 18369-1.2006 Ophthalmic optical contact lenses Part 1.Vocabulary, classification system and recommended marking indicators
ISO 18369-2.2006 Ophthalmic Optical Contact Lenses Part 2.Tolerance
ISO 18369-3.2006 Ophthalmic optical contact lenses Part 3.Test methods
3 Terms and definitions
The following terms and definitions apply to this part of YY 0719.
3.1
Follow the instructions or recommendations provided by the contact lens care product manufacturer, after removing the contact lens and before putting on the contact lens again
A series of nursing steps during the period.
3.2
The contact lens is cyclically operated according to the test procedure, in which a standard salt solution or a certified contact lens care product is used instead of the test.
Try care products.
Note. The control is not required to fully comply with this section, it can be used to obtain more test-related information.
3.3
In air, the reciprocal of the paraxial vertex focal length in meters in the optical zone of the contact lens, the dimension is m-1; the unit symbol is D (diopter).
3.4
The maximum size of the lens.
3.5
Under the normal incidence of natural light, the spectral radiant flux Φeλτ of a certain unit wavelength transmitted through the measured material in the standard salt solution is compared with that before the incident.
The ratio of the spectral radiant flux Φeλ, expressed as a percentage.
3.6
A contact lens that complies with UV absorption class 1 or class 2 performance.
3.7
Classification of contact lenses with UVA transmittance (τUVA)< 10%τ-(λV) and UVB transmittance (τUVB)< 1%τ-(λV).
3.8
Classification of contact lenses with UVA transmittance (τUVA)< 50%τ-(λV) and UVB transmittance (τUVB)< 5%τ-(λV).
3.9
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 flow chart 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 24h.
4.1.2 The cyclic operation of the contact lens should simulate the steps in the instruction manual provided by the test product manufacturer.
4.1.3 Within the allowable contact time range, the cycle should be carried out under the most unfavourable conditions.
4.1.4 Before and after the cycle operation, the designated physical parameters of the contact lens (see Table 1) should be measured to determine their changes. Should be manufactured
The product technical indicators provided by the supplier and the technical indicators and tolerances specified in GB 11417 are evaluated for their changes.
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 contact lens parameter changes during the cycle operation.
Figure 1 Flow chart
Table 1 Items and test methods
Project test method
Total diameter (limited to hydrogel lenses) ISO 18369-3
Radius of curvature (limited to hard lenses) ISO 18369-3
Rear vertex ISO 18369-3
Spectral transmittance
ISO 18369-3
(Limited to UV-absorbing lenses and cosmetic lenses)
Physical appearance
(E.g. surface defects, color)
ISO 18369-3
4.2 Methods to distinguish between reversible and irreversible changes in contact lens characteristics
4.2.1 Only when the tested contact lens care product is tested according to the 4.1 test method, the change in contact lens characteristics exceeds the finished product technical index provided by the manufacturer
And the technical indicators and tolerances specified in GB 11417, only use this method.
4.2.2 The measured lenses in the test group were rebalanced in the standard salt solution and re-measured to distinguish between reversible and irreversible
Variety.
4.2.3 According to the technical indicators of the finished product provided by the manufacturer and the technical indicators and tolerances specified in GB 11417, the measurement in the standard salt solution
The contact lens parameters were evaluated.
Note. For some types of contact lens materials, such as ionic materials, the ion concentration of the standard salt solution may affect its parameters (shown on the label).
5 Selection of test lenses
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 of each test group
All results should be obtained on the basis of no less than 10 pieces.
5.2 The contact lens test material group should represent the type of contact lens for which the care product is applicable. Contact lens material see ISO 18369-1
Said.
Note 1.Taking into account the current reports on the incompatibility of silicon-containing hydrogel lenses, it is recommended to conduct a separate compatibility test for this type of material.
Note 2.Among the minimum 10 lenses in each group used in this test, there should be lenses with extreme vertex power.
6 steps
6.1 Test methods for detecting changes in contact lens characteristics
6.1.1 Record the characteristics and treatment plan of the contact lens to be tested in detail. The record should include the test method and order of use of contact lens care products
And method.
6.1.2 For the contact lens care products to be used daily, perform 30 cycles of each selected material.
6.1.3 For products that are recommended as part of the care process (such as enzyme cleaners), the number of cycles should be representative of one month's use
Or at least 5 times.
6.1.4 For each contact lens care program tested, at least 10 lenses in each test group, if necessary, another 10 lenses are needed as a control program.
6.1.5 Before the test, put the contact lens in a standard salt solution to equilibrate for at least 15 minutes or until the contact lens parameters are stable. Determination of contact lens
Characteristic parameters and record data. At least the items listed in Table 1 should be measured.
6.1.6 Carry out the contact lens cycle operation and record the time of each cycle operation.
Note. Special attention should be paid to recording the time taken for each step in the nursing plan.
6.1.7 After the cycle operation, measure the characteristics of the contact lens again in the test solution. The contact lens of the control group should be measured in the control solution.
6.1.8 Determine the changes in contact lens characteristics and compare them with the finished product technical indicators provided by the manufacturer and the technical indicators and tolerances specified in GB 11417.
Compare poorly.
6.2 Test methods to distinguish between reversible and irreversible changes in contact lens characteristics
6.2.1 If the changes in lens characteristics obtained according to the test method in 6.1 exceed the finished product technical indicators provided by the manufacturer and the GB 11417 standard
When the specified technical indicators and tolerance range are set, this test shall be carried out.
6.2.2 Use the standard salt solution of 6.1 to soak the same contact lens, equilibrate for at least 15min or until the contact lens parameters are stable.
6.2.3 After immersing in a standard salt solution to equilibrium, measure the characteristics of the contact lens.
6.2.4 Determine the changes and compare them with the technical indicators of the finished product provided by the manufacturer and the technical indicators and tolerances specified in GB 11417.
6.3 Judgment of results
6.3.1 After the completion of the 6.1 test, if the changes in the contact lens characteristics observed are based on the finished product specifications provided by the manufacturer and GB 11417
Within the technical indicators and tolerances specified in the, it is determined that the tested product is physically compatible with the contact lens material.
6.3.2 After completing the 6.2 test, if the observed change in contact lens characteristics is based on the finished product specifications provided by the manufacturer and GB 11417
Within the technical indicators and tolerances specified in, it is determined that the test product is physically compatible with the contact lens material for reversibility.
6.3.3 After completing the 6.2 test, if the observed change in the contact lens characteristics exceeds the technical specifications and specifications of the finished product provided by the manufacturer
The technical indicators and tolerance ranges specified in GB 11417 are determined to be physically incompatible with the contact lens material.
Note. This test plan should give a pass/fail judgment rule.
7 Test report
The test report should include at least the following information.
a) The description, batch number and expiration date of the contact lens material;
b) The description, batch number and expiration date of the contact lens care product;
c) Test plan (if necessary);
d) Test results;
e) The name and location of the test laboratory;
f) The name of the person in charge;
g) The date of the test and the signature of the approver.