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YY/T 0290.1-2021 English PDF

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YY/T 0290.1-2021: (Ophthalmic optics intraocular lens - Part 1: Terminology)
Status: Valid

YY/T 0290.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0290.1-2021English379 Add to Cart 4 days [Need to translate] (Ophthalmic optics intraocular lens - Part 1: Terminology) Valid YY/T 0290.1-2021
YY 0290.1-2008English479 Add to Cart 3 days [Need to translate] Ophthalmic implants. Intraocular lenses. Part 1: Terminology Obsolete YY 0290.1-2008
YY 0290.1-1997English439 Add to Cart 4 days [Need to translate] Intraocular Ienses. Part 1: Terminology Obsolete YY 0290.1-1997

PDF similar to YY/T 0290.1-2021


Standard similar to YY/T 0290.1-2021

YY/T 0290.5   YY 0290.8   YY 0290.2   YY/T 0290.4   YY/T 0290.6   YY 0290.3   

Basic data

Standard ID YY/T 0290.1-2021 (YY/T0290.1-2021)
Description (Translated English) (Ophthalmic optics intraocular lens - Part 1: Terminology)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Word Count Estimation 19,195
Issuing agency(ies) State Drug Administration

YY/T 0290.1-2021: (Ophthalmic optics intraocular lens - Part 1: Terminology)

---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 optics intraocular lens part 1.terminology) ICS 11.040 C40 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0290.1-2008 Ophthalmic optical intraocular lens Part 1.Terminology Ophthalmicoptics-Intraocularlenses-Part 1.Terminology (ISO 11979-1.2018, Ophthalmicimplants-Intraocularlenses- Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration

foreword

YY/T 0290 "Ophthalmic Optical Intraocular Lens" is divided into 9 parts. --- Part 1.Terminology; --- Part 2.Optical properties and test methods; --- Part 3.Mechanical properties and test methods; --- Part 4.Labels and information; --- Part 5.Biocompatibility; --- Part 6.Validity period and transport stability; --- Part 8.Basic requirements; --- Part 9.Multifocal intraocular lenses; --- Part 10.Phakic intraocular lenses. This part is part 1 of YY 0290. This section is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY/T 0290.1-2008 "Ophthalmic Optical Intraocular Lens Part 1.Terminology", and YY/T 0290.1- Compared with.2008, the main technical changes except editorial changes are as follows. ---Add terms and definitions "Intraocular lens parent type", "Intraocular lens type", "Aspherical intraocular lens", "Spherical intraocular lens" "Toric IOL", "Accommodating IOL", "Closed Loop IOL", "Open Loop IOL", "Open Closed IOL" Hybrid-loop intraocular lens", "transmission system", "intraocular lens implantation system", "pre-installed system" (see 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21); ---Add terms and definitions "additional power", "highest power meridian", "lowest power meridian", "equivalent spherical power", "cylinder lens" degree", "compensation lens", "far point", "near point", "high optical power configuration", "low optical power configuration", "adjustment amplitude", "cutoff wavelength", "human vision" Power" (see 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18); ---Add terms and definitions "effective optical zone", "dome height", "axial mark", "minimum power meridian indicator", "apex" "Optical Surface Factor" "Compression Force" (see 4.2, 4.11, 4.12, 4.13, 4.14, 4.15, 4.16). This section uses the redrafted method to modify and adopt ISO 11979-1.2018 "Ophthalmic Implants and Intraocular Lenses - Part 1.Terminology". Compared with ISO 11979-1.2018, this part has more structural adjustments. Appendix A lists this part and ISO 11979-1. 2018 chapter number comparison list. There are technical differences between this part and ISO 11979-1.2018, and the clauses involved in these differences have been identified by the outer margins Placed vertical single line (|) is marked. The technical differences between this part and ISO 11979-1.2018 and their reasons are as follows. --- Delete the relevant definitions of ISO 11979-7 clinical investigation to adapt to the situation in our country; --- Combine 3.1.9 and 3.1.26 in ISO 11979-1.2018 to define 3.4 (see 3.4) of this part to adapt to the situation in our country; --- Modified ISO 11979-1.2018 3.1.31 Definition of Intraocular Lens Implant System Terms, and YY/T 0942-2014 Relevant terminology remains basically the same; --- Modified ISO 11979-1.2018 3.1.66 Definition of pre-installed system terms, and related terms in YY/T 0942-2014 Be basically the same. The following editorial changes have been made to this section. --- Modified the standard name; --- Added Chinese and English indexes; --- Removed references. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This part is proposed by the State Drug Administration. This part is regulated by the National Optical and Photonics Standardization Technical Committee Medical Optics and Instruments Sub-Technical Committee (SAC/TC103/SC1) focal point. This section is drafted by. Zhejiang Institute of Medical Device Inspection. The main drafters of this section. Feng Qin, Chen Qionghui, Xia Zhongcheng, Song Ting, Luo Yongjie. The previous versions of the standards replaced by this part are as follows. ---YY 0290.1-1997, YY/T 0290.1-2008. Ophthalmic optical intraocular lens Part 1.Terminology

1 Scope

This part of YY/T 0290 defines the terms used for intraocular lenses and their testing.

2 General terms and definitions

2.1 intraocular lens; IOL An optical lens implanted in the eyeball. 2.2 The entire intraocular lens is placed in the back chamber of the eye. 2.3 The entire intraocular lens is placed in the anterior chamber of the eye. 2.4 Intraocular lenses for refractive adjustment in phakic eyes. 2.5 Simulate intraocular state insitu Intraocular state insitu The state of aqueous humor balance in the human eye at 35°C ± 2°C. Note 1.The refractive index of aqueous humor is 1.336 when the wavelength is 546.07nm. Note 2.In the actual test, in general, normal saline solution can be used instead of aqueous humor. Note 3.If it has been verified that the test value under other conditions can be corrected to simulate the intraocular state, it can be tested under other conditions. 2.6 An intraocular lens with only one power. 2.7 An intraocular lens with two or more optical powers. 2.8 multi-piece intraocular lens Intraocular lens consisting of separate haptics and body. Note. Intraocular lenses consisting of a main body and two haptics are often referred to as three-piece intraocular lenses. 2.9 One-piece intraocular lens one-piece intraocularlens A haptic is an intraocular lens that is an integral part of the body.

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