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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0107-2024: A mode ultasonic biometer for ophthalmology scanner Status: Valid YY/T 0107: Historical versions
Basic dataStandard ID: YY/T 0107-2024 (YY/T0107-2024)Description (Translated English): A mode ultasonic biometer for ophthalmology scanner Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C41 Classification of International Standard: 11.040.50; 11.040.70 Word Count Estimation: 14,188 Date of Issue: 2024-09-29 Date of Implementation: 2025-10-15 Older Standard (superseded by this standard): YY/T 0107-2015 Issuing agency(ies): State Drug Administration Summary: This standard specifies the product classification and requirements for ophthalmic A-type ultrasonic measuring instruments and the corresponding test methods. This standard applies to ophthalmic ultrasonic measuring instruments with A-type display, which are mainly used for the measurement of corneal thickness and axial length in ophthalmology. YY/T 0107-2024: A mode ultasonic biometer for ophthalmology scanner---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 11.040.50;11.040.70 CCSC41 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY/T 0107-2015 Ophthalmic A-type ultrasonic measuring instrument Released on 2024-09-29 Implementation on October 15, 2025 The State Drug Administration issued ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY/T 0107-2015 "Ophthalmic Type A Ultrasonic Measuring Instrument". Compared with YY/T 0107-2015, except for structural adjustments and In addition to editorial changes, the main technical changes are as follows. --- Changed the description of "Classification by power source used" (see 3.2, 3.2 of the.2015 edition); --- Changed the requirements and test methods for "measurement range" (see 4.1 and 5.1, 4.1 and 5.1 of the.2015 edition); --- Changed the requirements and test methods for "measurement error" (see 4.2 and 5.2, 4.2 and 5.2, 5.3 of the.2015 edition); --- Changed the requirements for "effective number of displayed digits" (see 4.3, 4.3 of the.2015 edition); --- Changed the requirements for "additional functions" (see 4.4, 4.4 of the.2015 edition) --- Changed the requirements for "internal power supply working time" (see 4.5, 4.5 of the.2015 edition); --- Deleted the requirements and test methods for "power supply voltage adaptability" (see 4.7 and 5.8 of the.2015 edition); --- Changed the requirements and test methods of "Environmental test" (see 4.7 and 5.7, 4.8 and 5.10 of the.2015 edition); --- Changed the requirements and test methods for "safety" (see 4.8 and 5.8, 4.9 and 5.7 of the.2015 edition); --- Deleted "Inspection Rules" (see Chapter 6 of the.2015 edition); --- Deleted "Marking and Instructions for Use" (see Chapter 7 of the.2015 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the Medical Ultrasonic Equipment Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC2). This document was drafted by. Tianjin Mida Medical Technology Co., Ltd. and Hubei Medical Device Quality Supervision and Inspection Institute. The main drafters of this document are. Yang Jun, Wu Chengzhi, Zhang Yusheng, Lin Sen, Ke Gang and Jiang Shilin. The previous versions of this document and the documents it replaces are as follows. ---First published in 1983 as WS2-303-1983, first revised in.1993 as YY 0107-1993, second revised in.2005 Revised, third revision in.2015; ---This is the fourth revision. Ophthalmic A-type ultrasonic measuring instrument1 ScopeThis document specifies the product classification and requirements of ophthalmic type A ultrasonic measuring instruments (hereinafter referred to as "measuring instruments") and describes the corresponding tests. method. This document is applicable to ophthalmic ultrasonic measuring instruments with A-type display, which are mainly used for measuring corneal thickness and axial length in ophthalmology. Measurement.2 Normative referencesThe contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance GB 9706.237 Medical electrical equipment Part 2-37.Basic safety and essential performance of ultrasonic diagnostic and monitoring equipment Require GB/T 14710 Environmental requirements and test methods for medical electrical appliances YY/T 1420 Environmental requirements and test methods for medical ultrasonic equipment YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility Requirements and tests3 Product categories3.1 Classification by function Measuring instruments are mainly divided into the following types. a) Ophthalmic A-type ultrasonic measuring instrument for corneal thickness measurement (keratometer); b) ophthalmic A-type ultrasonic measuring instrument for measuring axial length (axial length measuring instrument); c) Ophthalmic A-type ultrasound measuring instrument for measuring corneal thickness and axial length. 3.2 Classification by power source Measuring instruments are mainly divided into the following types. a) Type A ophthalmic ultrasonic measuring instrument operated by mains power; b) Type A ophthalmic ultrasonic measuring instruments operating with an internal power supply; c) Ophthalmic Type A ultrasonic measuring instrument that can operate using both mains power and internal power supply.4 Requirements4.1 Measurement range 4.1.1 The measuring range of corneal thickness of the measuring instrument should cover 0.300mm~1.200mm. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0107-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 0107-2024_English as soon as possible, and keep you informed of the progress. 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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 0107-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0107-2024 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. |
