JJF 1781-2019 English PDF

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JJF 1781-2019: Program of Pattern Evaluation of Applanation Tonometers
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Basic data

Standard ID: JJF 1781-2019 (JJF1781-2019)
Description (Translated English): Program of Pattern Evaluation of Applanation Tonometers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A53
Classification of International Standard: 17.100
Word Count Estimation: 20,285
Date of Issue: 2019
Date of Implementation: 2020-03-31
Issuing agency(ies): State Administration for Market Regulation

JJF 1781-2019: Program of Pattern Evaluation of Applanation 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 Applanation Tonometers National Measurement Technical Specification of the People's Republic of China Outline of Type Evaluation of Contact Squeezing Tonometer Published on December 31,.2019 2020-03-31 Implementation Issued by the State Administration of Market Supervision and Administration Contact flattening tonometer Type evaluation outline Centralized unit. National Pressure Measurement Technical Committee Main drafting unit. China Academy of Metrology Shanghai Institute of Metrology and Testing Technology This specification entrusts the National Pressure Measurement Technical Committee to interpret The main drafters of this specification. Zhu Jianping (Chinese Academy of Metrology) Zhang Zhongli (Shanghai Institute of Metrology and Testing Technology) Yang Lei (Chinese Academy of Metrology)

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 Requirements for units of measurement (2) 5.2 Measurement legality marks and measurement equipment marking requirements (2) 5.3 Technical information that the applicant should submit (2) 6 Measurement requirements (3) 6.1 Force error (3) 6.2 Flattened circle diameter (3) 6.3 Flatness of the front surface of the measuring head (3) 7 General technical requirements (3) 7.1 Appearance (3) 7.2 Climate environment adaptability (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 methods and conditions of test items, data processing and qualification criteria (4) 10.1 Force error (4) 10.2 Flattened circle diameter (5) 10.3 Flatness of the front surface of the measuring head (6) 10.4 Rated working low temperature test (7) 10.5 Rated working high temperature test (8) 10.6 Judgment of type evaluation results (8) 11 Table of measuring instruments and equipment used in the test project (8) 12 Type evaluation record format (9) Appendix A Appraisal Record Format for Flattened Tonometer Type (10)

Introduction

This type evaluation outline is based on JJF 1015-2014 "General Specification for Type Evaluation of Measuring Instruments", JJF 1016- 2014 "Guidelines for the Compilation of the Outline of Type Appraisal of Measuring Instruments" was prepared. The technical indicators of this type evaluation outline refer to JJG1141-2017 "Contact Flattening Tonometer", GB/T 14710-2009 "Environmental requirements and test methods for medical appliances" and ISO 8612..2009 "Ophthalmic instruments "Tonometer" and other technical documents. This type evaluation outline is released for the first time. Outline of Type Evaluation of Contact Squeezing Tonometer

1 Scope

This type of evaluation outline is applicable to the range of optical-mechanical structure and measuring head force (hereinafter referred to as force) to Including (0 ~ 49) mN contact applanation tonometer (hereinafter referred to as applanation tonometer) type evaluation

2 Reference documents

The following documents are cited in this type evaluation outline. JJG1141-2017 contact flattening tonometer GB/T 14710-2009 Environmental requirements and test methods for medical appliances 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

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]

4 Overview

The flattened tonometer is a special instrument used to measure the intraocular pressure in the ophthalmology diagnosis. The working principle of the flattened tonometer is based on the Imbert-Fick principle. treating the eyeball as an ideal dry surface Elastic thin-walled sphere, the intraocular pressure p, the force F and the flattened area A of the cornea have the formula (1) relationship. p = F/A (1) When measuring, it is usually used in conjunction with a slit lamp, and the measuring head of a flattened tonometer is used to flatten the cornea and root of a certain area. According to the required force to measure the intraocular pressure (see Figure 1). Figure 1 Schematic diagram of flattening the tonometer The flattened tonometer can be divided into two types of scale type and digital display type according to the display method, mainly by the measuring head, measuring arm, ......

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