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[Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 5: Testing methods for optical properties
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GB/T 11417.5-2012
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Basic data | Standard ID | GB/T 11417.5-2012 (GB/T11417.5-2012) | | Description (Translated English) | [Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 5: Testing methods for optical properties | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 17,159 | | Quoted Standard | GB/T 5702-2003; GB/T 11417.1-2002; GB/T 11417.4-2002; GB 17341-1998 | | Adopted Standard | ISO 18369-3-2006, NEQ | | 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 finished contact lens. |
GB/T 11417.5-2012: [Including 2022XG1] Ophthalmic optics -- Contact lenses -- Part 5: Testing methods for optical properties ---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 5. Test methods for optical properties
Part 5. Testingmethodsforopticalproperties
(ISO 18369-3.2006, Ophthalmicoptics-Contactlenses-
Part 3. Measurementmethods, NEQ)
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
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 5.
Rules in this section in accordance with GB/T 1.1-2009 given draft.
This section uses redrafted law reference ISO 18369-3.2006 "Ophthalmic optics - Contact lenses - Part 3. Methods of measurement" establishment.
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. JIA Xiao Hang, Wen Yan, Qi Weiming, He Tao, Zheng, Zhang Jingdong, just yellow.
Ophthalmic optics Contact lenses
Part 5. Test methods for optical properties
1 Scope
GB/T 11417.5 specifies the test method of contact lens optical properties.
This section applies to the finished contact lens.
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 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 11417.4-2002 Ophthalmic optics - Contact lenses - Part 4. Test standard saline solution
GB 17341-1998 Optics and optical instruments focimeter
3 Terms and Definitions
GB/T 11417.1-2012 defined and the following terms and definitions apply to this document.
3.1
Reproduction condition reproducibilityconditions
In different laboratories by different operators using different equipment, the same test sample using the same test methods to obtain mutual independence
The test results established conditions.
3.2
Reproducibility limit reproducibilityvalue
In the reproduction conditions of the absolute difference between two single test results, expected probability of not greater than the R-value of 95%.
4 Determination of back vertex power
4.1 General
After a contact lens vertex in the air can be measured by using focimeter, in a salt solution may be measured using Moire deflection device or Hartmann method (see
4.2.3 and Appendix A).
4.2 focus meter measurement method
4.2.1 Instrument Performance
It should be consistent with GB 17341-1998 focimeter measure, but the contact lenses need to be modified as follows probe head.
Relative to the frame of the lens, the contact lens vector height bigger, smaller optical zone diameter, measured in seat frame lens focus meter equipped with a contact
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