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GB 38455-2019: Ophthalmic instruments - Ophthalmometers
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Ophthalmic instruments - Ophthalmometers
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GB 38455-2019
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Basic data | Standard ID | GB 38455-2019 (GB38455-2019) | | Description (Translated English) | Ophthalmic instruments - Ophthalmometers | | Sector / Industry | National Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 10,115 | | Date of Issue | 2019-12-31 | | Date of Implementation | 2022-01-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 38455-2019: 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
National Standards of People's Republic of China
Instead of YY0579-2016
Corneal curvature meter
(ISO 10343..2014, MOD)
2019-12-31 release
2022-01-01 implementation
State Administration of Market Supervision
Published by the National Standardization Administration
Contents
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirement 2
4.1 General requirements 2
4.2 Curvature Radius Measurement 2
4.3 Axial measurement of the main meridian 2
4.4 Eyepiece adjustment (if applicable) 3
5 Test method 3
5.1 Overview 3
5.2 Inspection requirements for curvature radius measurement 3
5.3 Inspection of axial measurement of main meridian 3
6 Attached documents 4
7 Mark 4
Appendix A (informative) Test device and test setup for checking the axial direction of the main meridian 5
Reference 7
Foreword
All technical contents of this standard are mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY0579-2016 Ophthalmic Instrument Corneal Curvature Meter. Compared with YY0579-2016, except for editorial changes
The main technical changes are as follows.
--- Added the term and definition of "corneal refractive constant" (see 3.5);
--- Deleted the term and definition of "front surface corneal power" (see 3.5 in the.2016 edition)
--- Added the term and definition of "corneal diopter" (see 3.6);
--- Increased general requirements for electrical safety and electromagnetic compatibility (see 4.1);
--- Modified the curvature radius measurement range and measurement tolerance requirements of A-type corneal curvature meter, B-corneal curvature meter curvature radius measurement allowance
Poor requirements (see 4.2, 4.2 of.2016 version).
This standard uses the redrafting method to modify and adopt ISO 10343..2014 "Ophthalmic Instrument Corneal Curvature Meter".
Compared with ISO 10343..2014, this standard has some structural adjustments.The international standard 5.2 has been changed to this standard 5.2.1 and added.
5.2.2 and 5.3.
There are technical differences between this standard and ISO 10343..2014, and the terms related to these differences have passed through the margins on the outer margins
The installed vertical single line (|) is marked.
The technical differences between this standard and ISO 10343..2014 and the reasons are as follows.
--- Regarding normative references, this standard has made adjustments with technical differences to suit China's technical conditions and the situation of adjustment.
The situation is reflected in Chapter 2 "Regulatory Reference Documents", and the specific adjustments are as follows.
● Replaced IEC 60601-1 with GB 9706.1 equivalent to the international standard (see 4.1, Chapter 6, Chapter 7);
● Added reference to YY0505 (see 4.1).
--- Added the data processing method of Chapter 5 test method to make the test method operable (see 5.2.2, 5.3.2).
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This standard is proposed and managed by the State Drug Administration.
This standard was drafted. Zhejiang Medical Device Inspection Institute.
The main drafters of this standard. Jia Xiaohang, Wang Jingtao, Peng Jianhua, Hu Yiping.
The previous versions of the standards replaced by this standard are.
--- YY0579-2005, YY0579-2016.
Corneal curvature meter
1 Scope
This standard specifies the terms and definitions, requirements and test methods of continuous or digital indicating corneal curvature meters.
This standard applies to continuous or digital indication corneal curvature meter.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (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)
YY0505 Medical electrical equipment-Part 1-2. General requirements for safety. Collateral standard. EMC requirements and tests
(YY0505-2012, IEC 60601-1-2..2004, IDT)
ISO 8429 Optics and Optical Instruments Ophthalmology Dial Scales (Opticsandopticalinstruments-Ophthal-
mology-Graduateddialscale)
ISO 15004-1..2006 Basic requirements and test methods for ophthalmic instruments. Part 1. General requirements for ophthalmic instruments
instruments-Fundamentalrequirementsandtestmethods-Part 1. Generalrequirementsapplicable
toalophthalmicinstruments)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Corneal curvature meter
An instrument used to measure the radius of curvature and the axial direction of the principal meridian in the central area of the human cornea and/or contact lens.
3.2
Distance-dependentophthalmometer
A corneal curvature meter whose measurement results are affected by the distance between the instrument and the surface being measured.
3.3
Toroidalsurface
A surface formed by a circular arc rotating about an axis in the same plane but not passing through the center of curvature of the arc, having two orthogonalities
The round, "main meridian", one largest and one smallest.
3.4
Principalcurvaturedirection
The direction of the smallest or largest radius of curvature of the reflecting surface to be measured.
3.5
Keratometricconstant
The constant 337.5 is used to convert corneal curvature from the inverse of millimeters (mm-1) to corneal refractive power.
[ISO .19980..2012, definition 3.11]
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