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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0675-2023: Ophthalmic instruments - Synoptophores Status: Valid YY/T 0675: Historical versions
Basic dataStandard ID: YY/T 0675-2023 (YY/T0675-2023)Description (Translated English): Ophthalmic instruments - Synoptophores Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C40 Classification of International Standard: 11.040.70 Word Count Estimation: 10,137 Date of Issue: 2023-09-05 Date of Implementation: 2024-09-15 Older Standard (superseded by this standard): YY/T 0675-2008 Issuing agency(ies): State Drug Administration Summary: This standard specifies the minimum requirements and test methods for telescopes. Synopsis machines are used to examine, measure, train and correct patients' binocular vision as well as measure horizontal, vertical and rotational deviations at different gaze positions. This standard applies to simulcast machines. YY/T 0675-2023: Ophthalmic instruments - Synoptophores---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.ICS 11.040.70 CCSC40 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0675-2008 Ophthalmology equipment synopsis machine (ISO 10944.2009,MOD) Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration ForewordThis document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY/T 0675-2008 "Ophthalmic Instrument Simultaneous Vision Machine". Compared with YY/T 0675-2008, except for structural adjustment and compilation In addition to editorial changes, the main technical changes are as follows. ---Deleted the requirement that the corresponding optical radiation safety standards should be met in the general requirements (see 4.1 of the.2008 edition); ---Changed the requirements for adjustment range and scale graduation (minimum scale) (see Table 1 of 4.2, 4.2 of the.2008 edition); ---Deleted the requirement for "private information" (see 4.4 of the.2008 version); ---Deleted the "material" requirement (see 4.5 of the.2008 version); ---Deleted the requirement for "cleaning, disinfection or sterilization measures" (see 4.6 of the.2008 edition); ---Deleted the requirement for "environmental conditions" (see 4.7 of the.2008 edition). ---Added the "diffusion screen brightness change" test method (see 5.2.4); ---Added the "brightness difference between left and right diffuser screens" test method (see 5.2.5); ---Added the "brightness adjustment" test method (see 5.2.6). This document has been modified to adopt ISO 10944.2009 "Ophthalmic Instrument Simultaneous Vision Machine". The technical differences between this document and ISO 10944.2009 and their reasons are as follows. ---Changed the interpupillary distance grid value requirements (see 4.2 Table 1) to adapt to my country's technical conditions; ---Added the test method for the brightness change of the diffuse screen (see 5.2.4), the test method for the brightness difference between the left and right diffuse screens (see 5.2.5), and brightness adjustment Test methods (see 5.2.6) increase operability and facilitate the implementation of standards; ---Replaced IEC 60601-1.2005 (see Chapter 6 and Chapter 7) with normatively cited GB 9706.1-2020, the second of the two documents The degree of consistency between them is modified to adapt to my country's technical conditions. This document also has the following editorial changes. ---Replaced ISO 15004-1.2006 with ISO 15004-1.2020 (see Chapter 6). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is sponsored by the National Optics and Photonics Standardization Technical Committee Medical Optics and Instruments Sub-Technical Committee (SAC/TC103/ SC1) Return to home. This document was drafted by. Zhejiang Medical Device Inspection Institute, Suzhou Liuliu Vision Technology Co., Ltd. The main drafters of this document. Wang Jingtao, Pang Jie, Hu Yiping, Peng Jianhua, Wang Hanxiang, and Huang Tao. The previous versions of the documents replaced by this document are as follows. ---First released in.2008 as YY 0675-2008; ---This is the first revision. Ophthalmology equipment synopsis machine1 ScopeThis document specifies the minimum requirements and test methods for telescopes. This document is applicable to synoptic machines used to examine, measure, train and correct binocular vision of patients and measure the horizontal and vertical angles at different gaze positions. Straight and rotational deviation.2 Normative reference documentsThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1. 2012,MOD) ISO 15004-1.2020 Basic requirements and test methods for ophthalmic instruments Part 1.General requirements for ophthalmic instruments (Ophthalmic3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Synoptophore majoramblyoscopes synoptometer It is an instrument designed to display alternating optotypes for each eye, and the displayed optotypes can be displayed in different forms and with different convergences. Positions move individually. Note. Optotype configuration and positioning, along with other instrument features, are used to test, measure and train binocular vision. 3.2 It is used to form two different images on the retinas of both eyes (one on each retina) and cannot be fused into a single image. 3.3 Used to form two similar images on the retinas of both eyes (one on each retina) that can be fused and often contain controls points to evaluate whether either eye inhibits the optotype pair of the associated image. 3.4 A pair of visual targets used to test and/or measure stereoscopic acuity that have a common reference point and form an image pair that is visually integrated. combined to produce a three-dimensional effect. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0675-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 0675-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0675-2023?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0675-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |