YY/T 1484-2016 English PDFUS$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1484-2016: Ophthalmic instruments--Instruments to measure axial distances in the eye Status: Valid
Basic dataStandard ID: YY/T 1484-2016 (YY/T1484-2016)Description (Translated English): Ophthalmic instruments--Instruments to measure axial distances in the eye Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C40 Word Count Estimation: 7,715 Date of Issue: 2016-07-29 Date of Implementation: 2017-06-01 Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129) Issuing agency(ies): State Food and Drug Administration YY/T 1484-2016: Ophthalmic instruments--Instruments to measure axial distances in the eye---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.Ophthalmic instruments - Instruments to measures axial distances in the eye ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Ophthalmic instrument eye axis length measuring instrument (ISO 22665..2012, MOD) 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Requirements 1 5 Test Method 2 6 random file 2 7 logo 2 Appendix A (Normative Appendix) Test Body and Measurement Assessment 3 ForewordThis standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to modify the international standard ISO 22665..2012 "ophthalmic instrument eye axis length meter" (English version). There are technical differences between this standard and ISO 22665..2012, and the terms involved in these differences have passed through the margin The vertical single line (|) is marked. The main technical differences between this standard and ISO 22665..2012 are as follows. --- on the normative reference documents, this standard has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "normative reference documents", the specific adjustments are. equivalent to the use of international standards GB 9706.1 generation For IEC 60601-1; --- Removes the requirements of ISO 22665 for the use of ultrasonic methods for axial length measuring instruments. It is clear in the scope of application that this standard applies to Optical method of axial length measuring instrument; --- supplemented the axial length measurement repeatability requirements and test methods. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1). The drafting of this standard unit. Zhejiang Medical Device Testing Institute. The main drafters of this standard. Wang Jingtao, Jia Xiaohang, He Tao, Qi Weiming, Peng Jianhua. Ophthalmic instrument eye axis length measuring instrument1 ScopeThis standard applies to the use of optical methods to measure the length of the instrument. This standard specifies the minimum requirements and test methods for the above instruments and systems.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT)3 terms and definitionsThe following terms and definitions apply to this document. 3.1 Axial length axiallength Along the axial axis, the distance between the anterior surface of the cornea and the retinal membrane (ILM) or retinal pigment epithelial cell layer (RPE). Note. The distance between the anterior retinal (ILM) and the retina (RPE) is approximately 100 μm in the central depression and about 300 μm at the center of the fovea. There are different ways of measuring the axial length, for example, in the ultrasound method, the distance between the anterior corneal surface and the retinal membrane (ILM) is measured; Method, the distance between the anterior surface of the cornea and the retinal pigment epithelial cell layer (RPE) was measured. 3.2 Aphakicmode A measuring mode and/or instrument setting for an axial length measuring instrument, which is used to measure aphakic eye (lens missing). 3.3 Group refraction rate grouprefractiveindex The ratio of the propagation rate (c0) of the light in the vacuum to the propagation rate (cg) of the light in the medium or the biological tissue is c0/cg. 3.4 Optical biometric measurement The length of the human eye axis is measured optically. 3.5 Have a lens pattern phakicmode A measuring mode and/or instrument setting for an axial length measuring instrument, which is used to measure the presence of a lens (lens).4 requirements4.1 axial length measurement tolerance. ± 100μm. 4.2 axial length measurement repeatability. ≤ 33μm. ...... |
