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JJG 1143-2017 English PDF

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JJG 1143-2017: Non-contact Tonometers
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
JJG 1143-2017299 Add to Cart 3 days Non-contact Tonometers Valid

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Basic data

Standard ID: JJG 1143-2017 (JJG1143-2017)
Description (Translated English): Non-contact Tonometers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A53
Classification of International Standard: 17.100
Word Count Estimation: 13,161
Date of Issue: 2017-11-20
Date of Implementation: 2018-02-20
Quoted Standard: ISO 8612-2009
Regulation (derived from): AQSIQ Notice 2017 No. 103
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This standard is applicable to the first verification, subsequent verification and in-service inspection of non-contact tonometers (hereinafter referred to as tonometers) that have passed the clinical test.

JJG 1143-2017: 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.
Non-contact Tonometers National metrological verification regulations of the People's Republic of China Non-contact tonometer Published on.2017-11-20 2018-02-20 Implementation The State Administration of Quality Supervision, Inspection and Quarantine issued Non-contact tonometer Verification procedure Undertaking unit. National Pressure Measurement Technical Committee Drafting unit. China Institute of Testing Technology China Institute of Metrology Shanghai Institute of Metrology and Measurement Technology Fujian Institute of Metrology Hangzhou Quality and Technical Supervision and Inspection Institute This procedure entrusts the National Pressure Measurement Technical Committee to explain Drafters of this regulation. Zhang Conghua (China Testing Technology Institute) Zhu Jianping (China Institute of Metrology) Tu Limeng (Shanghai Measurement and Measurement Technology Research Institute) Li Jie (Fujian Provincial Institute of Metrology) Gong Yue (China Testing Technology Institute) Liu Wenli (China Institute of Metrology) Jiang Xueping (Hangzhou Institute of Quality and Technology Supervision and Inspection)

table of Contents

Introduction (II) 1 Scope (1) 2 References (1) 3 Terms and units of measure (1) 3.1 Terms (1) 3.2 Units of measurement (1) 4 Overview (1) 5 Metrological performance requirements (1) 5.1 Measurement Range (1) 5.2 Indication Error (1) 5.3 Repeatability (1) 6 General technical requirements (1) 6.1 Appearance (1) 6.2 Identification (2) 6.3 Display (2) 7 Measuring Instruments Control (2) 7.1 Verification conditions (2) 7.2 Verification Projects (2) 7.3 Verification Methods (3) 7.4 Processing of verification results (4) 7.5 Certification Cycle (4) Appendix A Non-Contact Tonometer Verification Original Recording Format (5) Appendix B Certificate of Accreditation/Acknowledgement Results Notification Format (6)

Introduction

JJF1001 "General Measurement Terms and Definitions", JJF1059.1 "Evaluation and Expression of Uncertainty in Measurement", JJF1002 The “Rules for the preparation of national metrological verification regulations” together form the basic series of specifications that support the formulation of this verification protocol. This procedure is based on the ISO 8612.2009 Ophthalmic Instrument Tonometer. This regulation is issued for the first time. Non-contact tonometer verification procedure

1 Scope

This procedure is applicable to non-contact tonometers (hereinafter referred to as intraocular pressure) that have passed the clinical test and are qualified by the jet measurement method. First verification, follow-up verification, and in-use inspection.

2 references

This procedure cites the following documents. ISO 8612.2009 Ophthalmic instruments-Tonometers For dated references, only the dated version applies to this procedure; any undated references The latest version (including all amendments) is applicable to this procedure.

3 Terms and units of measure

3.1 Terms 3.1.1 intraocular pressure intraocularpressure[ISO 8612.2009,3.1] The pressure inside the eyeball. Referred to as intraocular pressure. 3.1.2 indication error errorofindication [JJF1001-2011, 7.32] Refers to the difference between the non-contact tonometer test display and the standard analog human eye display. 3.2 Units of measurement Intraocular pressure measurement unit name. kPa; symbol. kPa.

4 Overview

Tonometer is an instrument for measuring intraocular pressure. It is mainly used for intraocular pressure screening and uses the principle of Imber-Fick. Controlled air pulse squeezes the center of the cornea and deforms the cornea to form a circular plane with a diameter of about 3.6mm. At this point, the pressure of the air pulse is equal to the intraocular pressure, and the value of the intraocular pressure is measured. Tonometer mainly includes jet system, infrared pair Coke system, applanation monitoring system, data processing system, etc.

5 Metrological performance requirements

5.1 Measurement Range The tonometer's measurement range should include at least. (0.93~6.65)kPa. 5.2 Indication Error Tonometer indication maximum allowable error. ± 0.67kPa. 5.3 Repeatability Repeatability of tonometer. 0.13 kPa.

6 General technical requirements

6.1 Appearance 6.1.1 No significant damage to the tonometer, text and markings should be clearly visible.
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