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JJF 1291-2019 English PDFStandard Briefing:Stadard ID: JJF 1291-2019Stadard Title: Program of Pattern Evaluation of Eye refractomenters Price (USD): 789 Lead day (Deliver True-PDF English version): 7 days Status: Valid Evolution and Historical Versions:
Basic Data:
Contents, Scope, and Excerpt:JJF 1291-2019 Program of Pattern Evaluation of Eye refractomenters National Measurement Technical Specification of the People's Republic of China Outline of Type Evaluation of 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 Refractometer Replace JJF 1291-2011 Centralized unit. National Medical Metrology Technical Committee Main drafting unit. China Academy of Metrology Participated in the drafting unit. Shanghai Institute of Metrology and Testing Technology Shandong Institute of Metrology This specification entrusts the National Medical Metrology Technical Committee to interpret The main drafters of this specification. Sun Jie (Chinese Academy of Metrology) Hong Baoyu (Chinese Academy of Metrology) Xue Ruidan (Chinese Academy of Metrology) Participating drafters. Guan Xin (Shanghai Institute of Metrology and Testing Technology) Xiaowen Qin (Shandong Institute of Metrology) table of Contents Introduction (Ⅲ) 1 Scope (1) 2 References (1) 3 Overview (1) 3.1 Purpose (1) 3.2 Measuring principle (1) 4 Legal management requirements (1) 4.1 Unit of measurement (1) 4.2 Mark (1) 5 Measurement requirements (2) 5.1 Zero indication error (2) 5.2 Indication error of sphericity (2) 5.3 Repetition of sphericity measurement of objective refractometer (2) 5.4 Cylinder axis value indication error of objective refractometer (2) 5.5 Cylindricity indication error of objective refractometer (2) 5.6 Pupil distance indication error of objective refractometer (2) 5.7 Exit pupil illumination (2) 5.8 Indication error of radius of curvature (2) 5.9 Repeatability of curvature radius measurement (2) 5.10 Indication error of corneal curvature axis position (3) 6 General technical requirements (3) 6.1 Appearance (3) 6.2 Measurement capability (3) 6.3 Climate and environment adaptability (3) 6.4 Power environment adaptability (4) 7 Type evaluation items (4) 8 Technical documents and test prototypes to be submitted by the applicant (5) 8.1 Technical Information (5) 8.2 Test prototype (5) 9 Test methods and conditions for type evaluation items (5) 9.1 Preparation before the test (5) 9.2 Appearance (5) 9.3 Measurement capability (6) 9.4 Zero indication error (6) 9.5 Indication error of sphericity (7) 9.6 Repetition of sphericity measurement of objective refractometer (7) 9.7 Indication error of cylindrical position of objective refractometer (8) 9.8 Cylindricity indication error of objective refractometer (8) 9.9 Indication error of pupil distance of objective refractometer (9) 9.10 Exit pupil illumination (9) 9.11 Indication error of radius of curvature (10) 9.12 Repeatability of curvature radius measurement (10) 9.13 Indication error of corneal curvature axis position (11) 9.14 Climate and environment adaptability test (11) 9.15 Power environment adaptability test (13) 9.16 Judgment of type evaluation results (13) 10 Table of measuring instruments and equipment used in the test items (14) 11 Type evaluation record format (14) Appendix A Refractometer Type Evaluation Record Format (15) introduction JJF 1016-2014 "Guidelines for the Compilation of Evaluation Outlines for Measuring Instruments", JJF 1015-2014 "Measuring Instruments The “General Standards for Type Evaluation” together constitute the basic series of standards that support the revision of this type evaluation outline. This type of evaluation outline is based on JJG892-2011 "Refractometer", JJG922-2008 "Top Refractive Index of Refractometer Standard ”, JJG1011-2018“ keratometer ”, and refer to GB/T 14710-2009“ Medical appliances "Environmental Requirements and Test Methods" revises JJF 1291-2011 "Refractometer Type Evaluation Program". versus Compared with JJF 1291-2011, in addition to editorial changes, the main technical changes of this type of evaluation outline are as follows. --- Added the content of the introduction; --- In the scope, the classification code of the refractometer is added, and the "product quality used to guide the production process" is deleted. "Quantity supervision and inspection"; --- In the cited document, deleted GB 9706.1-2007 "Medical Electrical Equipment Part 1.Safety Communication "Usage requirements", JB/T 9329-1999 "Basic environmental conditions and test methods for instrumentation, transportation and storage", added Added GB/T 14710-2009 "Environmental requirements and test methods for medical appliances"; --- Removed terms, symbols, codes; --- According to JJF 1016-2014 "Guidelines for the Compilation of the Type Appraisal Outline of Measuring Instruments", the legal management requirements Content to be modified; --- In the measurement requirements, the requirement of corneal curvature axis position indication error is added; --- In the general technical requirements, the climatic and environmental adaptability and power environment adaptability are increased, and the safety requirements are deleted. Requirements, environmental adaptability requirements; --- According to JJF 1016-2014 "Guidelines for Compiling the Type Evaluation Outline of Measuring Instruments" in the type evaluation project Content to be modified; --- According to JJF 1015-2014 "General Specification for Type Appraisal of Measuring Instruments" added the Related requirements of technical data and test prototypes; --- In the test methods and conditions of the type evaluation project, the indication error of the corneal curvature axis position, the climate The description of the test methods and conditions of environmental adaptability and power supply environmental adaptability, the safety requirements and environmental adaptability requirements have been deleted Seek test methods and conditions for relevant test items; --- According to JJF 1016-2014 "Guidelines for the Compilation of Type Appraisal Outline for Measuring Instruments", increase the measurement for test items Table of appliances and equipment; --- In appendix A, the content of "refractor type evaluation report format" is deleted, and "refractor type" is added Format evaluation record format ". The release of previous versions of this type of evaluation outline. --- JJF 1291-2011. Outline of Type Evaluation of RefractometerScopeThis type evaluation outline is applicable to the type evaluation of various subjective and objective refractometers with classification code 33120000. 2 Reference documents The following documents are cited in this type evaluation outline. JJG892-2011 Refractometer JJG922-2008 Refractometer top power standard JJG1011-2018 keratometer 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 3.1 Purpose The refractometer is mainly used to measure the reference spherical degree, cylindrical degree, cylindrical axis position and interpupillary distance required by the optometry person. Indication. 3.2 Measuring principle The refractometer can be divided into a subjective refractometer and an objective refractometer according to the measurement principle. The subjective refractometer relies on the subject's subjective judgment on whether the target image is clear or not, to determine the subject's flexion Light state. The objective refractometer uses its photoelectric system to measure the light spot reflected on the retina of the examinee. To objectively determine the examinee's refractive state, without subjective judgment of the examinee. 4 Legal management requirements 4.1 Unit of measurement The various values of the refractometer should adopt the national legal unit of measurement. 4.2 Logo The refractometer should be marked with the measurement legal mark and the measurement instrument mark on the obvious nameplate or panel, body and other obvious parts of the instrument For identification, the signs, numbers and instructions must be clearly identifiable, firm and reliable. 4.2.1 The measurement legal symbol generally includes the following. The type approval mark and number of the measuring instrument (this item is a non-mandatory provision, and the test prototype can be left with a corresponding position). 4.2.2 The marking of measuring instruments generally includes the following. Instrument name, manufacturer name, specifications (model), manufacturing date, factory number. Have special requirements for installation The refractometer should have an installation instruction sign. ...... |