YY 0290.8-2022Ophthalmic optics - Intraocular lenses - Part 8: Fundamental requirements (English PDF)

Foreword

This document was drafted in accordance with the rules provided in GB/T 1.1-2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.

This document is part 8 of YY(/T) 0290 Ophthalmic optics - Intraocular lenses. The following parts have been issued for YY(/T) 0290:

-- Part 1: Terminology;

-- Part 2: Optical properties and test methods;

-- Part 3: Mechanical properties and test methods;

-- Part 4: Labeling and information;

-- Part 5: Biocompatibility;

-- Part 6: Shelf-life and transport stability;

-- Part 8: Fundamental requirement;

-- Part 9: Multifocal intraocular lenses;

-- Part 10: Phakic intraocular lenses.

This document serves as a replacement of YY 0290.8-2008 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirement. In comparison with YY 0290.8-2008, apart from structural adjustments and editorial modifications, the main technical changes are as follows:

-- Modify "Normative references" (see Chapter 2; Chapter 2 of the 2008 edition);

-- Modify "Safety and performance" (see Chapter 4; Chapter 4 of the 2008 edition);

-- Modify "Optical and mechanical properties" (see Chapter 5; Chapter 5 of the 2008 edition);

-- Modify "Biocompatibility" (see Chapter 6; Chapter 6 of the 2008 edition);

-- Modify "Clinical evaluation" (see Chapter 7; Chapter 7 of the 2008 edition);

-- Modify "General requirements" (see 9.1; 9.1 of the 2008 edition);

1 Scope

This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye. This document does not apply to corneal implants and transplants.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the version corresponding to that date is applicable to this document; for undated references, the latest version (including all amendments) is applicable to this document.

YY/T 0287, Medical devices - Quality management systems - Requirements for regulatory purposes (YY/T 0287-2017, ISO 13485:2016, IDT)

YY/T 0290.1, Ophthalmic optics - Intraocular lenses - Part 1: Terminology (YY/T 0290.1-2021, ISO 11979-1:2018, MOD)

YY 0290.2, Ophthalmic optics - Intraocular lenses - Part 2: Optical properties and test methods (YY 0290.2-2021, ISO 11979-2:2014, MOD)

YY 0290.3, Ophthalmic optics - Intraocular lenses - Part 3: Mechanical properties and test methods (YY 0290.3-2018, ISO 11979-3:2012, MOD)

YY/T 0290.4, Ophthalmic optics - Intraocular lenses - Part 4: Labeling and information (YY/T 0290.4-2008, ISO 11979-4:2000, IDT)

YY 0290.5, Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (YY 0290.5-2008, ISO 11979-5:2006, MOD)

YY/T 0290.6, Ophthalmic optics - Intraocular lenses - Part 6: Shelf-life and transport stability (YY/T 0290.6-2021, ISO 11979-6:2014, MOD)

YY 0290.10, Intraocular lenses - Part 10: Phakic intraocular lenses (YY 0290.10-2009, ISO 11979-10:2006, MOD)

YY/T 0316, Medical devices - Application of risk management to medical devices (YY/T 0316-2016, ISO 14971:2007, rectified, IDT)

YY/T 0640, Non-active surgical implants - General requirements (YY/T 0640-2016, ISO 14630:2012, IDT) Pharmacopoeia of the People's Republic of China

3 Terms and definitions

For the purposes of this document, the terms and definitions given in YY/T 0290.1 apply.

4 Safety and performance

The safety and performance of an intraocular lens shall be demonstrated by pre-clinical and clinical evaluation, including suitable risk in accordance with YY/T 0316.

In cases where a test method referenced in YY 0290 is not suitable for a certain design or a certain application, an alternative test method devised by the manufacturer shall be validated, justified and documented.

5 Optical and mechanical properties

The manufacturer shall ensure that the intraocular lens conforms to applicable requirements in YY 0290.2, YY 0290.3 and YY 0290.10. The manufacturer shall record and justify any deviations from the above standards.

6 Biocompatibility

The manufacturer shall have documented evidence that demonstrates the intraocular lens to be biocompatible by assessment in accordance with YY 0290.5.

Manufacturers can take into consideration previous experience and data when determining the extent of further biocompatibility testing.

7 Clinical evaluation

The clinical evaluation shall be carried out in accordance with the relevant provisions of the clinical evaluation of medical devices in our country.

Note: The first step in the clinical evaluation is a review of the available literature (published and unpublished) in order to determine if that information is sufficient to demonstrate the safety and performance of the device. One option is to demonstrate that the new intraocular lens model is a minor modification of a parent model, the safety and performance of which has previously been