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JJF 1780-2019: Program of Pattern Evaluation of Non-contact Tonometers
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Program of Pattern Evaluation of Non-contact Tonometers
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JJF 1780-2019
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Basic data | Standard ID | JJF 1780-2019 (JJF1780-2019) | | Description (Translated English) | Program of Pattern Evaluation of Non-contact Tonometers | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A53 | | Classification of International Standard | 17.100 | | Word Count Estimation | 24,213 | | Date of Issue | 2019 | | Date of Implementation | 2020-03-31 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 1780-2019: Program of Pattern Evaluation of Non-contact Tonometers---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.
Program of Pattern Evaluation of Non-contact Tonometers
National Measurement Technical Specification of the People's Republic of China
Outline of Type Evaluation of Non-Contact Tonometer
Published on December 31,.2019
2020-03-21 Implementation
Issued by the State Administration of Market Supervision and Administration
Outline of Type Evaluation of Non-Contact Tonometer
Centralized unit. National Pressure Measurement Technical Committee
Main drafting unit. Shanghai Institute of Metrology and Testing Technology
Chinese Academy of Metrology
This specification entrusts the National Pressure Measurement Technical Committee to interpret
The main drafters of this specification.
Zhang Zhongli (Shanghai Institute of Metrology and Testing Technology)
Zhu Jianping (Chinese Academy of Metrology)
Wang Can (Shanghai Institute of Metrology and Testing Technology)
table of Contents
Introduction (Ⅱ)
1 Scope (1)
2 References (1)
3 Terms and definitions (1)
4 Overview (1)
5 Legal management requirements (2)
5.1 Unit of measurement (2)
5.2 Marks and logos (2)
5.3 External structure design requirements (2)
5.4 Technical information that the applicant should submit (2)
6 Measurement requirements (3)
6.1 Indication error (3)
6.2 Repeatability (3)
7 General technical requirements (3)
7.1 Appearance (3)
7.2 Functional requirements (3)
7.3 Range of mechanical motion (3)
7.4 Environmental adaptability (3)
7.5 Electromagnetic compatibility (4)
8 Type evaluation item table (4)
9 Provide the number of prototypes and how to use them (4)
9.1 Number of test prototypes (4)
9.2 Use of prototype (4)
10 Test conditions and methods (4)
10.1 Reference environmental conditions for type evaluation (4)
10.2 Range of mechanical motion (5)
10.3 Indication error (5)
10.4 Repeatability (6)
10.5 Rated working low temperature test (6)
10.6 Rated working high temperature test (7)
10.7 Rated working damp heat test (8)
10.8 Electromagnetic compatibility (8)
11 Judgment principles for type evaluation results (9)
12 Table of measuring instruments and equipment used in the test project (9)
Appendix A Non-contact Tonometer Type Evaluation Record Format (11)
Introduction
This type evaluation outline is based on JJG1143-2017 "Non-Contact Tonometer" and refers to ISO 8612..2009
"Ophthalmology tonometer" was developed. JJF 1001-2011 "General Measurement Terms and Definitions", JJF 1015-2014
"General Specification for Type Appraisal of Measuring Instruments", JJF 1016-2014 "Guidelines for Compiling Outlines of Type Appraisal of Measuring Instruments",
JJF 1059.1-2012 "Measurement Uncertainty Evaluation and Representation" together constitute the work to support the formulation of this type of evaluation outline
The basic series of documents.
This specification is the first release.
Outline of Type Evaluation of Non-Contact Tonometer
1 Scope
This type evaluation program is applicable to the type evaluation of the non-contact tonometer with air-jet measurement method.
2 Reference documents
This specification refers to the following documents.
JJG1143-2017 non-contact tonometer
GB 4824-2013 Industrial, Scientific and Medical (ISM) Radio Frequency Equipment Disturbance Characteristics Limits and Measurements
method
GB 9706.1-2007 Medical electrical equipment Part 1.General requirements for safety
GB/T 14710-2009 Environmental requirements and test methods for medical appliances
YY0505-2012 Medical electrical equipment Part 1-2.General requirements for safety Parallel standards. Electromagnetic and
Capacity requirements and testing
ISO 8612..2009 Ophthalmic instruments tonometer (Ophthalmicinstruments-Tonometers)
For dated reference documents, only the dated version is applicable to this type of evaluation outline; those that are not dated
The latest version (including all amendments) of the cited documents is applicable to this type evaluation outline.
3 Terms and definitions
The following terms and definitions apply to this type of evaluation outline.
3.1 intraocular pressure; IOP
The pressure in the eyeball, referred to as intraocular pressure. The unit is kilopascal (kPa).
[ISO 8612..2009, definition 3.1]
3.2 Standard analog human eye referencephantomofIOP
It has been traced back to the simulated human eye in SI units, and is used as the reference standard for the tonometer's intraocular pressure indication.
3.3 Reference standard IOP pressureofreferencephantomofIOP
The standard obtained through the traceability of the value simulates the overall standard intraocular pressure of the human eye.The sources of pressure include the influence of the cornea.
Inside, it is not just the nominal pressure of the internal pressure sensing element that simulates the human eye.
4 Overview
Non-contact tonometer (hereinafter referred to as tonometer) is an instrument for measuring intraocular pressure, mainly used for intraocular pressure screening,
Using the Imber-Fick principle, a controlled air pulse is used to squeeze the center of the cornea to deform the cornea, and
The light beam reflected by the cornea is detected by a photodetector until the cornea is flattened to a diameter range of about 3.6mm
At that time, the light energy it received also reached the maximum value, and the pressure of the air pulse was equal to the intraocular pressure. How it works
As shown in Figure 1.
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