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GB 11417.3-2012: Ophthalmic optics -- Contact lenses -- Part 3: Soft contact lenses
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Ophthalmic optics -- Contact lenses -- Part 3: Soft contact lenses
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Basic data | Standard ID | GB 11417.3-2012 (GB11417.3-2012) | | Description (Translated English) | Ophthalmic optics -- Contact lenses -- Part 3: Soft contact lenses | | Sector / Industry | National Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 11,187 | | Older Standard (superseded by this standard) | GB 11417.2-1989 | | Quoted Standard | GB/T 2829-2002; GB/T 3978-2008; GB/T 5702-2003; GB/T 11417.1-2002; GB/T 16886.5; GB/T 16886.10; GB/T 16886.11; YY/T 0297; YY/T 0316; Chinese Pharmacopoeia 2010 edition two | | Regulation (derived from) | National Standards Bulletin No. 41 of 2012 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard soft contact lens provides terms and definitions, requirements, test methods, inspection rules, marking, labeling and accompanying information requirements. This standard applies to soft contact lens. | GB 11417.3-2012: Ophthalmic optics -- Contact lenses -- Part 3: Soft contact lenses---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ophthalmic optics.Contact lenses.Part 3. Soft contact lenses
ICS 11.040.70
C40
National Standards of People's Republic of China
Replacing GB 11417.2-1989
Ophthalmic optics Contact lenses
Part 3. soft contact lenses
Issued on. 2012-12-31
2013-12-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This section 4.4.3.2,4.7.1 are recommended, the rest are mandatory.
"Optics - Contact lenses" and GB/T 28539 "Ophthalmic optics - Contact lenses and contact lens care products preservative uptake and release
Guidelines for determination of discharge "and GB/T 28538" Ophthalmic optics - Contact lenses and contact lens care products rabbit eye test compatibility of "common structure
Contact lens into the national standards.
"Optics - Contact lenses" is divided into nine sections.
--- Part 1. Vocabulary, classification and identification of recommended specifications; (GB/T 11417.1)
--- Part 2. rigid contact lenses; (GB 11417.2)
--- Part 3. soft contact lenses; (mandatory) (GB 11417.3)
--- Part 4. Test standard salt solution; (GB/T 11417.4)
--- Part 5. Test methods for optical properties; (GB/T 11417.5)
--- Part 6. Mechanical test methods; (GB/T 11417.6)
--- Part 7. Test methods for physical and chemical properties; (GB/T 11417.7)
--- Part 8. determination of validity; (GB/T 11417.8)
--- Part 9. ultraviolet and visible radiation aging test (in vitro method); (GB/T 11417.9)
This is Part 3.
This Part replaces GB 11417.2-1989 "soft hydrophilic contact lens" and the amendments of 1997.
This part of GB 11417.2-1989 and 1997 amendments of the differences are as follows.
--- Pair 5.1,5.2,5.3.2,5.3.4,5.3.5,5.3.6,5.3.7,5.3.8 requirements, test methods and inspection rules, marks do
The modification;
--- Deleted 5.3.1, Chapter 9 of the packaging, storage and Chapter 9 wearing provisions;
--- General supplemented with additional requirements, and a multifocal contact lens to correct aberrations class action, the prism substrate orientation, residual prism, light
Specifying the terms of performance, the optical zone diameter, material expression, material and chemical properties, stability and biocompatibility requirements, and
Information accompanying terms.
This section uses redrafted reference method ISO 14534.2002 "Ophthalmic optics - Contact lenses and contact lens care products basic requirements"
(English version) and ISO 18369.2006 "Ophthalmic optics - Contact lenses" series of international standard preparation.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the State Food and Drug Administration.
This part of the National Optics and Photonics Standardization Technical Committee medical optical instruments and Technical Committee (SAC/TC103 /
SC1) centralized.
This section drafted by. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit
The inspection.
The main drafters of this section. JIA Xiao Hang, He Tao, Wen Yan, Ma Li, Chen flowers, Zheng, Qi Weiming, JIANG Xiao Road.
This part of the standard replaces the previous editions.
--- GB 11417.2-1989.
Ophthalmic optics Contact lenses
Part 3. soft contact lenses
1 Scope
GB 11417.3 specifies the terms and definitions of the soft contact lens, requirements, test methods, inspection rules, signs, labels and accompanying information
Claim.
This section applies to soft contact lens.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated reference documents, the latest version of this (including any amendments) applies to this document.
GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB/T 3978-2008 standard lighting and geometric conditions
GB/T 5702-2003 light color evaluation method
GB/T 11417.1-2002 Ophthalmic optics - Contact lenses - Part 1. Vocabulary, classification and identification specifications recommended
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity
YY/T 0297 Medical Device Clinical Investigation
YY/T 0316 Medical Devices Risk Management for Medical Device Applications
People's Republic of China Pharmacopoeia 2010 edition two
3 Terms and Definitions
Terms and definitions GB/T 11417.1-2012 defined in this document apply.
4 Requirements
4.1 General
Suitable risk safety and performance of contact lenses should be evaluated by preclinical and clinical evaluation, including in accordance with YY/T 0316 conducted
analysis.
The following requirements of the finished product requirements. In addition to the following requirements, if the manufacturer declares that there are other additional features, it should give a detailed description, and mention
Requirements and test methods suitable for.
4.2 Optical Performance
4.2.1 General
For contact lenses for special medical purposes without having optical properties, if there is a clear description of the information that comes in and signs, the following requirements
Do not apply.
4.2.2 back vertex power, cylinder power and cylinder axis position
After the contact lens vertex, prescription cylinder power and cylinder axis position (if any), the nominal value of the state should be in the air in the aseptic packaging container
Tagging, tolerance nominal value shall be in accordance with Table 1.
Table 1 back vertex power, cylinder power and cylinder axial tolerance
Project Name Tolerance
After the vertex F'V
F'V ≤10.00D ± 0.25D
10.00D < F'V ≤20.00D ± 0.50D
F'V > 20.00D ± 1.00D
Prescription cylinder power F'C
F'C ≤2.00D ± 0.25D
2.00D < F'C ≤4.00D ± 0.37D
F'C > 4.00D ± 0.50D
Cylinder axial ± 5 °
Note. does not apply to a bifocal or more (excluding bifocal) of multifocal contact lenses.
For multifocal (including bifocal) contact lens design, as well as claiming a aberration correction or amelioration of the contact lens, the manufacturer shall be given
Summation authentication method, if applicable, should also be tested to prove actual back vertex power distribution in line with the optical axis of a cross-sectional design features.
4.2.3 prism
Contact lens prescription prism design, a prism substrate orientation nominal value under air condition should be marked on sterile containers. Office
Square design prism, a prism substrate orientation nominal value of the residual prism of tolerance and non-prism design tolerances shall comply with the provisions of Table 2.
Table 2 prism, a prism substrate alignment tolerance
Project Name Tolerance
Residuals a prism
F'V ≤6.00D ± 0.25cm/m
F'V > 6.00D ± 0.50cm/m
Prescription prism
F'V ≤6.00D ± 0.25cm/m
F'V > 6.00D ± 0.50cm/m
Orientation of the prism base b ± 5 °
a geometric center of the optical zone group Huai measurements.
Prism substrate alignment reference b ring surface of the lens vertex mirror axis.
4.2.4 light transmission properties
4.2.4.1 General
Contact lens transmittance in the visible region, ultraviolet color vision requirements and requirements shall comply with the following provisions. In addition to the following requirements, if used for special
Medical purpose contact lens, its light transmission properties have special requirements, shall be given in the accompanying detailed description of the information provided and the applicable requirements and tests
method.
4.2.4.2 visible region requirements
The light transmittance of the contact lens and color vision requirements should meet the following requirements.
a) under simulated use, light transmittance τV were measured in standard illuminant D65 and A, the results should not be less than 89%.
b) After the optical zone should be wearing glasses tinted contact lens color vision meets daily to analyze and evaluate the application. Impact analysis and color vision
Evaluation can be in line with spectrum illumination and CIE illuminant D Planck blackbody radiation through the CRI after the contact lens
Reduce the amount of analysis and practical application to evaluate. Correlated color temperature of illumination should be selected to characterize the actual application, at least the election
High, medium, and low color temperature of the lighting body and record the selected correlated color temperature and illumination.
Note 1. simulations using state of light transmission through the optical path refers to simulate the use of air - Lens - tear layer interface reflected light loss, this time calculated by
The refractive index of tear layer of 1.336 to take the measurement aperture stop is defined as 6.0mm.
Note 2. The color perception Impact Analysis chosen lighting body recommended GB/T 3978-2008 specified standard illuminant A, illuminant D50 and D75.
Note 3. The color rendering index calculation can be found in GB/T 5702-2003 light color evaluation.
Tinted contact lens optical zone if it claims to have a special application purpose spectral transmission does not apply to the above-mentioned light transmittance and (or) color vision
Requirements, the manufacturer shall, after wearing glasses, as the brightness and (or) depending on the color vision in the application of safety and efficacy evaluation, including follow
Suitable risk YY/T 0316 analysis carried out, as well as clinical evaluation in accordance with the relevant provisions of YY/T 0297 carried out.
4.2.4.3 ultraviolet requirements
Claiming that UV absorption type contact lens, at the minimum sales unit shall be marked with the case of "UV absorption type 1" or "UV absorption type 2" category.
UV absorbing contact lens type lens for typical applications in the ultraviolet spectrum average transmittance simulated using state should comply with Table 3
Provisions.
Table 3 transmittance requirements
Project Title Requirements
UV average
Transmittance τUVR
UV-A segment transmittance τUVA
Wavelength range
316nm ~ 380nm
Class 1 UV absorbing contact lens τUVA < 0.10τ (λV)
Class 2 UV absorbing contact lens τUVA < 0.50τ (λV)
UV-B segment transmittance τUVB
Wavelength range
280nm ~ 315nm
Class 1 UV absorbing contact lens τUVB < 0.01τ (λV)
Class 2 UV absorbing contact lens τUVB < 0.05τ (λV)
4.3 geometry
Contact lens base curve radius 4.3.1 or vector to a given base diameter is high, the overall diameter of the nominal value shall be marked on sterile containers; in the contact lens
The thickness of the heart in the accompanying information should be seized. The nominal value tolerances comply with the requirements of Table 4.
Table 4 geometry Tolerance
project name
Tolerance
The water content of < 70% moisture content ≥70%
Base curve radius r0a ± 0.20mm ± 0.25mm
Given base diameter of high vector a ± 0.05mm ± 0.07mm
The total diameter φT ± 0.20mm ± 0.25mm
Center thickness tc ± 0.02mm or ± [0.015mm 0.05tc]
a base curve or radius vector height can be used to characterize the curvature of the rear surface of the spherical equivalent, marked by one of the Selection manufacture. Recommended when measuring the diameter of the bottom of unity
10.00mm.
4.3.2 contact lens optical zone diameter should be not less than 7.0mm. If you can not meet the requirements of this provision, the manufacturer should be clear in the accompanying profile
Indeed description, and simultaneously give the corresponding risk warning.
Note. Only applies to the whole mirror single colored or non-colored contact lenses.
4.4 Material
4.4.1 presentation material
Manufacturers should be GB/T 11417.1-2012 Rules for contact lens materials classification and labeling.
For beauty class color enhancement or colored contact lenses should indicate the name of the class of dye used, and the ratio of the category, it should also be given to prove its application
Safe and reliable basis.
4.4.2 The physical properties of materials
4.4.2.1 refractive index
The refractive index of the nominal value of the contact lens in the accompanying information should be seized, the nominal value shall be valid bit and valid bit corresponds to tolerance, tolerance should be
± 0.005.
Never used for new materials, the refractive index of tolerance does not apply if the above, the manufacturer shall provide a finished application safety and efficacy Syndrome
Data, including risk analysis and evaluation.
4.4.2.2 Water Content
The water content of the nominal value of the contact lens should be seized on the smallest sales units, the absolute tolerance shall be ± 2%.
4.4.2.3 oxygen permeability
Oxygen permeability coefficient and the nominal value of the contact lens rear vertex of the amount of oxygen or typical application -3.00D lens nominal value should be in the accompanying funding
Compound seized. Oxygen permeability coefficient of the nominal value of the relative tolerance should be ± 20%; the amount of oxygen measured value shall not be less than 20% of the nominal value.
4.4.2.4 fade test
For beauty class color class or enhanced coloring contact lenses should fade test.
4.4.3 Performance Materials Chemistry
4.4.3.1 extraction test
Results finished contact lens material according to GB/T 11417.7-2012 extracted extraction rate should not exceed the manufacturer's.
Note. The extraction rate is given by the manufacturer have been evaluated by the biological material determined.
4.4.3.2 preservative uptake and release
For new materials never used, the test should be measured preservative uptake and release. Contact lens containing preservative and applicable
Contact lens preservative uptake and release test results of care products, are described in the accompanying profile.
NOTE. without the use of contact lens care products, this provision does not apply.
4.5 biocompatibility
4.5.1 General
Contact lenses should be finished by the biological evaluation to demonstrate that it has good biocompatibility. Biological Evaluation consideration 4.5.2,4.5.3,
Biological test results 4.5.4. For new materials never used, it should be 4.5.5 and 4.5.6 skin sensitization test with rabbit eyes
Capacitive research trials.
Note. The above new materials specifically refers to the primary contact lens material.
4.5.2 acute systemic toxicity test
Preparation of test solution. Press 6cm2/mL (sample surface area to extraction medium volume ratio) ratio of extraction, extraction media were
0.9% sodium chloride injection and vegetable oils, extraction temperature and time is preferably from 37 ℃ ± 1 ℃, 72h.
Test method according to GB/T 16886.11 specified, the result shall be no acute systemic toxicity.
4.5.3 acute eye irritation test
4.5.2 Preparation of test solution in accordance with the provisions in accordance with the test method GB/T 16886.10 specified, the result shall be no eye sting
Shock resistance.
4.5.4 Cytotoxicity test
Contact lens according to the agar diffusion test method GB/T 16886.5 specified in (final agar concentration of not more than 1.5g/L), the results
There should be no cytotoxicity.
4.5.5 Skin sensitization test
4.5.2 Preparation of test solution in accordance with the provisions of the method according to GB/T 16886.10 specified in test results should be no skin
Sensitization reaction.
4.5.6 Compatibility of the rabbit eye test
Rabbit eyes and contact lens compatibility should be good.
4.6 Microbiological requirements
Contact lenses should be used to supply aseptic packaging, sterility assurance level (SAL) should be less than 10-6, can be "People's Republic of China Pharmacopoeia
Method 2010 edition of two, "the. Aseptic packaging should be adequate protection under normal conditions of storage, transport and processing, aseptic packaging
Before opening or destroyed, you should be able to maintain sterility.
4.7 Stability
4.7.1 radiation aging test
In addition to abandon the date of the following month and the contact lens, the contact lens material finished radiation aging test should be carried out to confirm the optical properties and
Physical properties of materials still meet the requirements of 4.2,4.4.2.
4.7.2 Validity
Contact lens manufacturer shall perform tests to determine the validity of the lens storage life, and shall 7.1 Method labels.
4.8 inherent quality and surface defects
4.8.1 impurities and surface flaws
Contact lens in the solution was visually observed to enlarge 7 to 10 times, any inclusions should not affect the normal use, such as spots, heteroaryl residues
Thereof, or dendrites bubbles, and any defects such as surface cracks, broken edges.
4.8.2 edge profile
Contact lens edge profile should be consistent with the manufacturer's design characteristic shape given. In addition to the specific purposes should be uniform shape around the edges
Consistent.
5 Test methods
Chapter 4 of this standard to all the requirements of the criteria listed in A test can be performed to detect or appendix. A suitable method in Appendix No
Criteria, the manufacturer shall provide a suitable method. Detection or test methods provided should be considered as an analog of the human eye practical applications, including office
Treatment (e.g. in a standard balanced salt solution). Reproducibility of detection methods, should be better than half the prescribed tolerance limits.
6 Inspection rules
6.1 factory inspection
Factory inspection rule product by the manufacturer ourselves, but not less than the level of quality type test requirements.
6.2 Type tests
Type test type test is divided into general and special type testing, see Table 5.
Table 5 Type Test Category
Category Conditions Terms of pilot projects
General Type
Type test
Material (batch) tests a continuous production of materials for each batch 4.2.4,4.4.2b, 4.4.3.1
Processing quality inspection
Continuous production of not less than once a year
Normal production, such as structure, process changes may have a greater impact performance when
More than a year and then discontinued when to resume production
4.2.2,4.2.3,4.3,4.8
Special type testing
Market access for the first time before registration
Before the first application of new materials
Technical conditions change
The final product during storage any changes
There are signs that the product may cause side effects when used in human
All items fit
It refers to a material with the same material as the final product.
b4.4.2.3,4.4.2.4 inspection when required.
Note. registration inspection, market supervision and random inspection items and inspection rules require the implementation of the relevant provisions.
6.2.1 Quality Inspection Processing
6.2.1.1 processing quality inspection test sample should be not less than three batches of qualified products in a uniform sampling. Press each batch segment (check sampling related
Standards or guidelines) random sampling is required after the vertex sampling samples (including the power of the ring surface lenticular lens) representative.
6.2.1.2 processing quality inspection according to the provisions of GB/T 2829-2002 conducted using a sampling plan, determining the level Ⅱ, RQL (not
Acceptable quality level) is 15, it is determined array recommended for n = 20 [Ac = 1, Re = 2], but 4.2.2 should be fully qualified. Test items
Table 5.
6.2.2 Other inspection
Test other items required by the amount of test samples. Test results should be fully qualified.
7 signs, labels and accompanying information
7.1 marks, labels
7.1.1 lenses aseptic packaging, in addition to the provisions of Chapter 4 of the nominal value of the labeling requirements, but also should have at least the following flags.
a) the product name;
b) lot number or production date;
c) expiry date or expiry date and date of production.
7.1.2 lens on the smallest sales package, in addition to the provisions of Chapter 4 of the nominal value of the labeling requirements, but also at least the following information.
a) manufacturer's name, address and place of origin;
b) the product name, model;
c) the standard number, registration number;
d) batch number or production date;
e) expiry date or expiry date and date of production.
7.2 Information accompanying
Accompanying information should include the use of the specification and wear guides. Lens minimum sales unit should be shipped with instructions for use. Instructions for use
In addition to the book specified in Chapter 4 of the nominal value of the label, it shall include at least the following information.
a) The main performance and scope;
b) use of methods and precautions;
c) taboo issues;
d) recommended by the manufacturer of the relevant lens cleaning, disinfecting and storage methods, and indicate the applicable care products;
e) indicate the type of storage solution lenses (the lens may also be marked on the smallest sales package or on the lens aseptic packaging);
f) any other necessary instructions.
Appendix A
(Normative)
Standard Test Method for soft contact lens catalog
Soft contact lens testing and detection methods applicable criteria are as follows.
GB/T 11417.4-2012 Ophthalmic optics - Contact lenses - Part 4. Test standard saline solution
GB/T 11417.5-2012 Ophthalmic optics - Contact lenses - Part 5. Test methods for optical properties
GB/T 11417.6-2012 Ophthalmic optics - Contact lenses - Part 6. Test methods for mechanical properties
GB/T 11417.7-2012 Ophthalmic optics - Contact lenses - Part 7. Test methods for physical and chemical properties
GB/T 11417.8-2012 Ophthalmic optics - Contact lenses - Part 8. determination of validity
GB/T 11417.9-2012 ophthalmic optical contact lens Part 9. ultraviolet and visible radiation aging test (in vitro method)
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity
GB/T 28538-2012 Ophthalmic optics - Contact lenses and contact lens care products research and test the compatibility of rabbit eyes
GB/T 28539-2012 Determination Guide ophthalmic optical contact lenses and contact lens care products preservative uptake and release
People's Republic of China Pharmacopoeia 2010 edition two
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