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Basic data
| Standard ID | JJF 1837-2020 (JJF1837-2020) |
| Description (Translated English) | (Calibration specification for ophthalmology type A ultrasonic measuring instrument) |
| Sector / Industry | Metrology & Measurement Industry Standard |
| Classification of Chinese Standard | A59 |
| Word Count Estimation | 16,155 |
| Date of Issue | 2020-07-02 |
| Date of Implementation | 2021-01-02 |
| Regulation (derived from) | Announcement No. 29 (2020) of the State Administration for Market Regulation |
| Issuing agency(ies) | State Administration for Market Regulation |
JJF 1837-2020: (Calibration specification for ophthalmology type A ultrasonic measuring instrument)
---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.
(Calibration specification for ophthalmology type A ultrasonic measuring instrument)
National Metrology Technical Specification of the People's Republic of China
Specification for calibration of ophthalmic A-type ultrasonic measuring instrument
Published on 2020-07-02
2021-01-02 Implementation
Released by the State Administration for Market Regulation
Ophthalmology Type A Ultrasound Measuring Instrument
Calibration specification
Focal Point. National Medical Metrology Technical Committee
Main drafting unit. China Institute of Metrology
China Institute of Testing Technology
Wuxi Metrology and Testing Institute
This specification entrusts the National Medical Metrology Technical Committee to be responsible for the interpretation
The main drafters of this specification.
Sun Jie (China Institute of Metrology)
Zhang Conghua (China Institute of Testing Technology)
Wu Xiang (Wuxi Metrology and Testing Institute)
Participating drafters.
Hu Zhixiong (China Institute of Metrology)
Shi Min (Wuxi Metrology and Testing Institute)
Li Fei (China Institute of Metrology)
Wan Suming (Wuxi Metrology and Testing Institute)
content
Introduction (Ⅱ)
1 Scope(1)
2 References (1)
3 Terms and units of measurement(1)
3.1 Terminology (1)
3.2 Units of measurement (1)
4 Overview(1)
5 Metrology Characteristics(2)
5.1 Axial length(2)
5.2 Measuring range(2)
6 Calibration Conditions(2)
6.1 Environmental conditions (2)
6.2 Measuring standards and other equipment(2)
7 Calibration items and calibration methods (2)
7.1 Appearance and functional inspection (2)
7.2 Axial length(3)
7.3 Measuring range(3)
8 Expression of calibration results (4)
8.1 Calibration records (4)
8.2 Processing of calibration results (4)
9 Recalibration interval(5)
Appendix A Ophthalmology Type A Ultrasound Measurement Instrument Calibration Original Record (Recommended) Format (6)
Appendix B Calibration Certificate Inner Page (Recommended) Format (7)
Appendix C (20~30)℃ Temperature Range Theoretical Sound Velocity Table of Degassed Water(9)
Appendix D Example of Uncertainty Assessment of Axial Length Calibration (10)
Introduction
This specification is based on JJF 1001-2011 "General Metrology Terms and Definitions", JJF 1059.1-2012 "Measuring
Evaluation and Representation of Certainty", JJF 1071-2010 "Rules for Compilation of National Metrology Calibration Specifications".
The formulation of this specification refers to YY/T 0107-2015 "Ophthalmology A-Type Ultrasonic Measuring Instrument", GB/T 18022-
2000 "Measuring Method of Sound Velocity and Attenuation Coefficient of Longitudinal Wave in Rubber and Plastics in the Acoustic 1~10MHz Frequency Range".
This specification is published for the first time.
Specification for calibration of ophthalmic A-type ultrasonic measuring instrument
1 Scope
This specification applies to ophthalmic A-type ultrasonic measuring instruments (including other corneas based on the principle of ultrasonic echo biometry
Pachymeters, Axial Length Measuring Instruments) calibration.
2 Reference documents
This specification references the following documents.
GB/T 18022 Acoustic Measurement of Longitudinal Wave Sound Velocity and Attenuation Coefficient of Rubber and Plastics in the Frequency Range of 1~10MHz
method
YY/T 0107 Ophthalmology Type A Ultrasound Measuring Instrument
For dated references, only the dated version applies to this specification; for undated references
The latest version (including all amendments) applies to this specification.
3 Terminology and units of measurement
3.1 Terminology
3.1.1 axial length
Note. There are different measurement methods for axial length, the ultrasonic measurement method measures from the anterior surface of the cornea to the inner retinal limiting membrane (ILM)
The distance between them; the optical measurement method measures the distance from the anterior surface of the cornea to the retinal pigment epithelium (RPE).
3.1.2 Echobiometry
A method of measuring axial length by measuring the time between ultrasound echoes produced by two tissues in the eyeball.
3.1.3 Phakicmode
The test mode of the meter, which is used to measure the axial length of phakic eyes.
3.2 Units of measurement
Name of the unit of measure for length or thickness. mm; symbol. mm.
4 Overview
Ophthalmic A-type ultrasonic measuring instrument (hereinafter referred to as ophthalmic A-ultrasound)
The ultrasonic measuring equipment for measuring the axial length and corneal thickness of the human eye is mainly composed of a host and a measuring probe. ophthalmology
According to the detection depth, the measurement probes of A-ultrasound can be divided into probes for measuring axial length and probes for measuring corneal thickness. Measurement
When the ophthalmic A-ultrasound probe contacts the patient's ocular surface vertically, it emits an ultrasonic beam into the eye and receives the reflected echoes, and the echoes are converted into
The waveform of the amplitude intensity is displayed on the graph with the ultrasonic propagation time as the abscissa. The abscissa of the waveform when the ultrasound propagates
The interval represents the different depths of the detection echo; the ordinate echo amplitude represents the ultrasonic reflection coefficient of the measured object. from back
The wave distribution, envelope width and amplitude can accurately measure the human axial length and corneal thickness.
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