YY/T 0290.1-2021Ophthalmic optics—Intraocular lenses - Part 1: Terminology (English PDF)

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.

1 Scope

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

2 General terms and definitions