YY/T 0290.6-2021Ophthalmic optics-Intraocular lenses - Part 6: Shelf-life and transport stability (English PDF)

Foreword

YY/T 0290 "Ophthalmic Optical Intraocular Lens" is divided into 9 parts.

--- Part 1: Terminology;

--- Part 2: Optical properties and their test methods;

--- Part 3: Mechanical properties and their 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 6 of YY/T 0290.

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

This Part replaces YY/T 0290.6-2009 "Ophthalmic Optical Intraocular Lens Part 6: Validity Period and Transportation Stability", and Compared with YY/T 0290.6-2009, the main technical changes other than editorial changes are as follows.

--- Modified the "normative references" (see Chapter 2, Chapter 2 of the.2009 edition);

--- Revised "General Requirements" (see 4.1, 4.1 of the.2009 edition);

--- Modified the "test parameters" (see 4.3.2.1, 4.3.2.1 of the.2009 edition);

--- Added "pre-installed system" (see 4.3.2.2);

--- Modified the "test procedure" (see 4.3.2.3, 4.3.2.3 of the.2009 edition);

--- Modified the "accelerated validity test" (see 4.3.3, 4.3.3 of the.2009 edition);

--- Modified "Packaging Integrity" (see 4.4, 4.4 of the.2009 edition);

--- Modified the requirements for transportation stability test (see 4.5, 4.5 of the.2009 edition);

--- Modified the "Conclusion" (see 4.6, 4.6 of the.2009 edition);

--- Modified "Appendix A" (see Appendix A, Appendix A of the.2009 edition).

This part uses the redrafted method to modify and adopt ISO 11979-6:2014 "Ophthalmic Implants and Intraocular Lenses - Part 6: Validity Period" and transport stability".

There are technical differences between this part and ISO 11979-6:2014, and the clauses involved in these differences have been specified in the outer margins The vertical single line (|) of the position is marked. The technical differences between this part and ISO 11979-6:2014 and the reasons are as follows.

--- Regarding normative reference documents, this part has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.

The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.

- Replace ISO 10993-5 with GB/T 16886.5 which is equivalent to adopting international standards;

- Replace ISO 10993-12 with GB/T 16886.12 which is equivalent to adopting international standards;

- Replace ISO 11607-1 with GB/T 19633.1 which is equivalent to adopting international standards;

- Replace ISO 11607-2 with GB/T 19633.2 which is equivalent to adopting international standards;

- Replace ISO 14971 with YY/T 0316 which is equivalent to adopting international standards;

- Replace ISO 11979-1 with YY/T 0290.1 which is equivalent to adopting international standards;

- Added reference to YY/T 0942;

--- Modified the content of the cytotoxicity test [see 4.3.2.1k)] to suit my country's national conditions;

--- Modified the chemical reaction requirements between the pre-installed system and the intraocular lens material, in the form of a note (see 4.3.2.2), with Suitable for my country's national conditions;

--- Modified the actual storage conditions [see 4.3.2.3c)] to suit my country's national conditions. The following editorial changes have been made to this section.

--- Modified the standard name;

--- Add a note in the content of the general requirements (see 4.3.1);

--- Increase the number of samples in A.3 in Appendix A and the number of samples at zero time point in Table A.1;

--- Revised references.

Introduction

The purpose of a stability study is to determine, under the influence of a specified set of environmental conditions, over a sufficiently long period of time, how well an intraocular lens is Can still maintain the original characteristics.

In general for new intraocular lens materials, new compounds for intraocular lens materials, new packaging materials or new manufacturing processes In the investigation and research, the storage stability of intraocular lens material is an important factor. aging the lens in the storage container Experimental studies can be used to evaluate the storage stability of intraocular lenses.

Changes in material composition, material suppliers, manufacturing environment (including sterilization process), packaging design, or materials can all affect intraocular lenses The length of the expiry date, which requires a new test of the intraocular lens to determine its expiry date. product stability, packaging integrity and shipping The necessity of the study of infusion stability can be assessed according to YY/T 0316.

The design of stability experiments should be based on known IOL material properties and recommendations for IOL use. storage or acceleration The amount and identity of the extracted material obtained after aging tests are important for evaluating new intraocular lens materials.

According to the information obtained, the corresponding transportation and storage conditions can be recommended, so as to ensure the safety, validity and acceptability. The results obtained are also suitable for determining the expiry date of intraocular lenses.

Since the stability test is an experiment conducted on the material and integrity of the intraocular lens. Therefore, the stability of the intraocular lens What is studied is the characteristics of the material. Under the condition that the intraocular lens material, packaging material and production process remain unchanged, one type of intraocular lens can be treated.

Experiments are carried out on the body, and the verification results should be representative.

1 Scope

This part of YY/T 0290 specifies the tests to determine the validity period of sterile intraocular lenses (IOLs) in complete packages.

Procedures for establishing the stability of intraocular lenses during distribution and storage are included.

2 Normative references

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

GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test (GB/T 16886.5-2017,

ISO 10993-5:2009, IDT)

GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials (GB/T 16886.12- 2017, ISO 10993-12:2012, IDT)

GB/T 19633.1 Terminally sterilized medical device packaging - Part 1: Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1:2006, IDT)

GB/T 19633.2 Terminally sterilized medical device packaging - Part 2: Requirements for validation of forming, sealing and assembly processes (GB/T 19633.2-2015, ISO 11607-1:2006, IDT)

YY/T 0290.1 Ophthalmic Optical Intraocular Lens Part 1: Terminology (YY/T 0290.1-2008, ISO 11979-1. 2006, MOD)

YY/T 0316 Application of Medical Device Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971:2007 Correction version, IDT)

YY/T 0942 Ophthalmic Optical Intraocular Lens Implantation System

3 Terms and Definitions

Terms and definitions defined in YY/T 0290.1 apply to this document.

4 Requirements