YY 0290.3-2018Ophthalmic optics—Intraocular lenses - Part 3: Mechanical properties and test methods (English PDF)

Foreword

The full technical content of this standard is mandatory.

YY 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 and transport stability;

--- Part 8. Basic requirements;

---Part 9. Multifocal intraocular lens;

--- Part 10. There is a phakic intraocular lens. This part is the third part of YY 0290.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY 0290.3-2008 "Ophthalmic optical intraocular lens Part 3. Mechanical properties and test methods", and Compared with YY 0290.3-2008, the main differences are as follows.

--- Change the recommended terms to mandatory (see 4.9);

--- Increase the content of the introduction (see introduction);

--- Increase the requirements for the ring-shaped intraocular lens and the accommodating intraocular lens (see 4.1, Chapter 5, Chapter 6);

--- Modify the requirements of the gap analysis (see 4.3, 4.3 of the 2008 edition).

This section uses the drafting method to modify the use of ISO 11979-3:2012 "Ophthalmic Implants IOLs Part 3. Mechanical Properties and Test Method (English version). There are technical differences between this part and ISO 11979-3:2012. The terms involved in these differences have been passed.

The vertical single line (|) at the outer margin of the outer side is marked.

---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments The situation is reflected in Chapter 2, "Regulatory Citations", and the specific adjustments are as follows.

- Replace ISO 11979-1 with YY 0290.1;

- Replace ISO 11979-2 with YY 0290.2.

--- The introduction part deletes the relevant content of the ISO 11979-7 clinical investigation;

--- Remove from the scope "If the test method is also suitable for special intraocular lens design," content;

--- 4.1 Overview in the "for some designs and applications" after the addition of "YY 0290 requirements of this part, if not applicable, should give full rationale By ", delete "in this case". Add "Note. Factory inspection can determine its sampling rules according to the manufacturer's specific circumstances. " Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.

Introduction

This part of YY 0290 contains test methods with relevant requirements and test methods that do not have explicit requirements. The former for people The safety or performance of the working lens is necessary, while the latter provides basic information for the ophthalmologist or other intended users.

There are a variety of intraocular lens designs on the market, so in any case, it is suitable for all testers of intraocular lenses.

The law does not exist. It is expected that new materials currently being developed will lead to large-scale new designs, which may require revision or construction of the original method.

Establish other test methods. As with all standards, parties using standards can modify or improve the corresponding methods and provide relevant principles and tests.

Information and shall be consistent with this part of YY 0290.

In any case, given different tolerances are related to material or design, which reflects the current state of the product.

1 Scope

This section of YY 0290 specifies the main mechanical properties and test methods for intraocular lenses.

This section applies to the intraocular lens implanted in the anterior segment of the human eye. This section does not apply to corneal implants.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

YY 0290.1 Ophthalmic optical intraocular lens Part 1. Terminology (YY 0290.1-2008, ISO 11979-1:2006, MOD)

YY 0290.2 Ophthalmic optical intraocular lens Part 2. Optical performance and test methods (YY 0290.2-2009, ISO 11979-2:1999, MOD)

3 Terms and definitions

The terms and definitions defined in YY 0290.1 apply to this document.

4 Requirements