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JJF 1773-2019: Program of Pattern Evaluation of Phoropters
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JJF 1773-2019: Program of Pattern Evaluation of Phoropters

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Program of Pattern Evaluation of Phoropters National Measurement Technical Specification of the People's Republic of China Outline of Type Evaluation of Comprehensive Refractometer Published on December 31,.2019 2020-03-31 Implementation Issued by the State Administration of Market Supervision and Administration Outline of Type Evaluation of Comprehensive Refractometer ofPhoropters Centralized unit. National Medical Metrology Technical Committee Main drafting unit. China Academy of Metrology Participated in the drafting unit. Zhejiang Institute of Metrology This specification entrusts the National Medical Metrology Technical Committee to interpret The main drafters of this specification. Liu Wenli (Chinese Academy of Metrology) Li Fei (Chinese Academy of Metrology) Hong Baoyu (Chinese Academy of Metrology) Participating drafters. Wang Wenxing (Zhejiang Institute of Metrology)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 References (1) 3 Overview (1) 4 Legal management requirements (2) 4.1 Unit of measurement (2) 4.2 Logo (2) 5 Measurement requirements (3) 5.1 Measuring range and reading interval (3) 5.2 Indication error of sphericity (3) 5.3 Cylindricity indication error (3) 5.4 Optical center deviation (3) 5.5 Cylindrical axis position indication error (4) 6 General technical requirements (4) 6.1 Appearance (4) 6.2 Climate and environment adaptability (4) 6.3 Power environment adaptability (5) 7 Type evaluation items (5) 8 Technical documents and test prototypes to be submitted by the applicant (5) 8.1 Technical Information (5) 8.2 Number of prototypes provided (6) 8.3 How to use the prototype (6) 9 Test methods and conditions for type evaluation items (6) 9.1 Preparation before the test (6) 9.2 Appearance (6) 9.3 Indication error of sphericity (6) 9.4 Cylindricity indication error (8) 9.5 Optical center deviation (8) 9.6 Cylindrical axis position indication error (9) 9.7 Climate and environment adaptability test (9) 9.8 Power environment adaptability test (11) 9.9 Judgment of type evaluation results (11) 10 Table of measuring instruments and equipment used in the test items (12) 11 Type evaluation original record format (12) Appendix A Original Record Format of Comprehensive Refractometer Type Evaluation (13)

Introduction

This type evaluation outline is based on JJF 1015-2014 "General Specification for Type Evaluation of Measuring Instruments", JJF 1016- 2014 Compilation of "Guidelines for the Compilation of Type Appraisal Outline of Measuring Instruments". The technical indicators of this type evaluation outline refer to JJG1097-2014 "Comprehensive Refractometer (including Eyesight Chart)" And GB/T 14710-2009 "Environmental requirements and test methods for medical appliances" and other technical documents, of which JJG1097- 2014 is the primary reference standard. This type evaluation outline is released for the first time. Outline of Type Evaluation of Comprehensive Refractometer

1 Scope

This type evaluation program is applicable to the type evaluation of the comprehensive refractometer with the classification code of 33900000.

2 Reference documents

The following documents are cited in this type evaluation outline. JJG1097 comprehensive refractometer (including eye chart) GB/T 14710 Environmental requirements and test methods for medical appliances 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 Overview

Comprehensive refractometer, also known as refractorhead, commonly known as lung head or bull's eye, is used for optometry Spherical lens, cylindrical lens, prism lens, various auxiliary lenses and various adjustment components are integrated in one vision inspection equipment Through the superposition and combination of the lenses on different mirror disks inside, the human eye's refractive state and visual function can be checked. Comprehensive refractometers can be generally divided into manual mechanical type and automatic computer type according to the operation mode. Combined refractometer (hereinafter referred to as "manual comprehensive refractometer") requires the operator to manually control the roulette to achieve different optometry Combination of numbers, and the automatic computer-based comprehensive refractometer (hereinafter referred to as "automatic comprehensive refractometer") consists of multiple stepping Machine control, through the operation wheel dial, buttons or touch screen to electrically control the combination of various lenses to complete the corresponding Check function. Figure 1 Schematic diagram of the internal structure and lens setting sequence of the manual comprehensive refractometer ...