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GB/T 11417.7-2012: [Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 7: Physicochemical properties test methods
Status: Valid
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[Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 7: Physicochemical properties test methods
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GB/T 11417.7-2012
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Basic data | Standard ID | GB/T 11417.7-2012 (GB/T11417.7-2012) | | Description (Translated English) | [Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 7: Physicochemical properties test methods | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 26,213 | | Quoted Standard | GB/T 6682-2008; GB/T 11417.1-2012; GB 11417.2-2012; GB 11417.3-2012; GB/T 11417.4-2012; GB/T 11417.6-2012 | | 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 standard applies to contact lenses physical and chemical properties of the test. | GB/T 11417.7-2012: [Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 7: Physicochemical properties test methods
---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.
ICS11.040.70
C40
National Standards of People's Republic of China
Ophthalmic optics Contact lenses
Part 7. Test methods for physical and chemical properties
Part 7. Physicochemicalpropertiestestmethods
Issued on. 2013-06-01 2012-12-31 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
Physical and chemical properties of the contact lens 4 1
4.1 Test methods, units, repeatability 1
4.2 Extraction 2
4.3 oxygen permeability coefficient of 4
A refractive index of 4.4 16
4.5 moisture content 17
4.6 contact angle 19
5 21 test reports
Foreword
"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; (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 7.
Rules in this section in accordance with GB/T 1.1-2009 given draft.
This technical content part reference ISO 18369-4.2006 "Ophthalmic optics - Contact lenses - Part 4. Physical and chemical properties test method" and
ANSIZ80.20-2004 "ophthalmic contact lens standard terminology, tolerances, measurement and physicochemical properties."
Please note that some of the content of this document may involve patent issuing authority of this 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. Wen Yan, JIA Xiao Hang, He Tao, Qi Weiming, Zhang Li, Huang precisely.
Ophthalmic optics Contact lenses
Part 7. Test methods for physical and chemical properties
1 Scope
GB/T 11417.7 gives the test methods for physical and chemical properties of the contact lens material, including extraction, oxygen permeability coefficient, refractive index, and the water content
Contact angle.
This section applies to a contact lens physical and chemical properties of the test.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated edition applies to this article
Member. For undated references, the latest version of this (including any amendments) applies to this document.
GB/T 6682-2008 analytical laboratory use specifications and test methods
GB/T 11417.1-2012 Ophthalmic optics - Contact lenses - Part 1. Vocabulary, classification and identification specifications recommended
GB 11417.2-2012 optics - Contact lenses - Part 2. rigid contact lenses
GB 11417.3-2012 optics - Contact lenses - Part 3. Soft contact lenses
GB/T 11417.4-2012 Ophthalmic optics - Contact lenses - Part 4. Test standard saline solution
GB/T 11417.6-2012 Ophthalmic optics - Contact lenses - Part 6. Test methods for mechanical properties
3 Terms and Definitions
Terms and definitions GB/T 11417.1-2012 defined in this document apply.
Physical and chemical properties of the contact lens 4
4.1 Test methods, units, repeatability
Table 1 has been used in the production of hydrogel contact lens and physicochemical properties of the hydrogel material is non-measurable. In addition, Table 1 to
A test method for these properties, units and repeatability. The use of other test methods should also comply with the following provisions.
Table 1 Physical and chemical properties of test methods, units, repeatability
Item Unit Test Method for Measuring the repeatability
B extracted mass fraction 4.2
Oxygen permeation coefficient of 10% Dk units a 4.3
The refractive index of 0.01 dimensionless 4.4
Moisture content of 2% (absolute value) 4.5%
The contact angle of 2 ° (°) 4.6
aDk unit is 10-11 (cm2/s) [mLO2/(mL · hPa)].
b according to the GB/T 11417.1-2012 terms and definitions, these repeatable test results established by independent laboratories.
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