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Ophthalmic instruments - Ophthalmometers
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YY 0579-2005 | English | 479 |
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Basic data Standard ID | YY 0579-2016 (YY0579-2016) | Description (Translated English) | Ophthalmic instruments - Ophthalmometers | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C40 | Classification of International Standard | 11.040.70 | Word Count Estimation | 10,125 | Date of Issue | 1/26/2016 | Date of Implementation | 2018-01-01 | Older Standard (superseded by this standard) | YY 0579-2005 | Quoted Standard | GB 9706.1; ISO 15004-1-2006; ISO 8429 | Adopted Standard | ISO 10343-2009, MOD | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the requirements and test methods for continuous or digital indication of corneal curvature. Some corneal curvature meters are capable of measuring the radius of curvature of a contact lens, which assumes that the anterior surface of the cornea and the surface of the contact lens are spherical or toric. If there is a difference, this standard takes precedence over ISO 15004-1-2006. |
YY 0579-2016: Ophthalmic instruments - Ophthalmometers---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 instruments - Ophthalmometers
ICS 11.040.70
C40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0579-2005
Ophthalmic instruments Corneal curvature
(ISO 10343..2009, MOD)
2016-01-26 release
2018-01-01 implementation
State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 requirements 2
5 Test methods 3
6 random file 4
7 mark 4
Appendix A (informative) A ring surface test device for checking the radial direction of a meridian
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0579-2005 "corneal curvature meter". The main technical differences between this standard and YY 0579-2005 are as follows.
--- delete the classification (2005 edition of Chapter 4);
- Removed the requirements for light exposure (2005 Edition 5.4) and the test method (2005 edition 6.5);
- Removed the appearance requirements (2005 edition 5.5) and the test method (2005 edition 6.5);
- Removed the positioning adjustment requirements (2005 edition 5.6) and the test method (2005 version 6.6);
- Removal of biocompatibility requirements (2005 edition 5.7) and test methods (2005 edition 6.8);
- Removed environmental requirements (2005 edition 5.9) and test methods (2005 edition 6.10);
- the inspection rules were deleted (Chapter 7 of.2005);
--- Removal of inspection certificate mark requirements (2005 version 8.1.2);
--- Removal of packaging, transportation and storage requirements (2005 edition 9).
This standard adopts the re-drafting method to modify ISO 10343..2009 "ophthalmic instrument corneal curvature meter".
There are technical differences between this standard and ISO 10343..2009, and the terms involved in these differences have been passed through the margin in its outer margin
The vertical single line (|) is marked. The technical differences between this and ISO 10343..2009 and the reasons are as follows.
--- on the normative reference documents, this standard has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation
The situation is reflected in Chapter 2, "Normative references", as follows.
Replace IEC 60601-1 with GB 9706.1.
- Measure the deviation from Table 1 in ISO 10343..2009, type 1 from "± 0.015mm" to "± 0.03mm", type 2
"± 0.05mm" to "± 0.06mm".
The data processing method of 5.2.2 and 5.3.2 in Chapter 5 of the test method has been added. The test method is operable.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1).
The drafting of this standard unit. Zhejiang Medical Device Testing Institute.
The main drafters of this standard. Wang Jingtao, Jia Xiaohang, Qi Weiming, Peng Jianhua.
This standard was first published in December.2005.
Ophthalmic instruments Corneal curvature
1 Scope
This standard, together with ISO 15004-1..2006, specifies the requirements and test methods for continuous or numerical indication of corneal curvature. Some horns
Membrane curvature (type 1 in Table 1) is able to measure the radius of curvature of the corneal contact lens, assuming that the corneal anterior surface and the contact lens surface are balls
Face or ring surface.
If there are differences, this standard takes precedence over ISO 15004-1..2006.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT)
ISO 15004-1..2006 Basic requirements and test methods for ophthalmic instruments - Part 1. General requirements for all ophthalmic instruments
(Ophthalmicinstruments-Fundamentalrequirementsandtestmethods-Part 1. Generalrequirementsappli-
cabletoalophthalmicinstruments
ISO 8429 Optics and Optical Instruments Ophthalmology-Ophthalmology-
Graduateddialscale)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Corneal curvature meter
Designed for measuring and indicating the radius of curvature of the main meridian of the human cornea and the area of the corneal contact lens.
3.2
Distance - dependent corneal curvature meter - dependentophthalmometer
The corneal curvature is measured by the distance between the instrument and the surface to be measured.
3.3
Ring surface toroidalsurface
By an arc around the same plane, but not through the arc curvature of the center of the axis of rotation formed by the surface, with two
Orthogonal, round "main meridian", one maximum, one minimum.
3.4
Main meridian direction principalcurvaturedirection
The radius of curvature of the surface to be measured is the smallest or the largest direction.
3.5
Corneal anterior surface
The corneal power calculated by the following formula.
F = (n-1) · 1000/r
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