YY/T 0871-2022Ophthalmic optics-Contact lenses-Hygienic management of multipatient use trial contact lenses (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

This document replaces YY/T 0871-2013 "Hygienic treatment of ophthalmic optical contact lenses for multi-patient try-on contact lenses", and YY/T 0871- Compared with.2013, the main technical changes except editorial changes are as follows.

--- Changed the "scope" (see Chapter 1, Chapter 1 of the.2013 edition);

--- Changed the "normative reference document" (see Chapter 2, Chapter 2 of the.2013 edition);

--- Changed "Terms and Definitions" (see Chapter 3, Chapter 3 of the.2013 edition);

--- Changed "Methods of Hygienic Handling of Contact Lenses for Multiple Patient Trials" (see Chapter 4, Chapter 4 of the.2013 edition);

--- Added "Selection of Hygienic Treatment Methods for Trying Contact Lenses for Multiple Patients" (see Chapter 5);

--- Added "Flowchart for the use of multi-patient try-on contact lenses" (see Chapter 6);

--- Changed "Appendix A" (see Appendix A, Appendix A of the.2013 edition).

This document uses the redrafted method to modify the use of ISO.19979.2018 "Ophthalmic Optical Contact Lenses Hygiene for Multi-Patient Try-On Contact Lenses" Processing" (in English). There are technical differences between this document and ISO.19979.2018, and the clauses involved in these differences have been adopted in the margin The vertical single line (|) in the blank position is marked. The technical differences between this document and ISO.19979.2018 and the reasons are as follows.

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

The specific situation is reflected in "2 Normative Reference Documents" and "3 Terms and Definitions", and the specific adjustments are as follows.

- Replace ISO 18369-1 with GB/T 11417.1 which is modified to adopt international standard. The following editorial changes have been made to this document.

--- Changed the introduction.

--- Changed references.

Introduction

This document provides guidance for manufacturers to write relevant information for use by eye care professionals for multi-patient try-ins Hygienic treatment of hydrogel, composite and rigid gas permeable (RGP) contact lenses.

This document can be used to guide the development of hygienic handling procedures for multi-patient try-on contact lenses.

1 Scope

This document specifies guidelines for the hygienic handling of contact lenses for multi-patient try-on.

This document is intended to guide hygienic handling procedures for multiple patient try-on contact lenses. This document does not apply to.

--- labeling of contact lenses;

--- Inactivation of prions and viruses.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 11417.1 Ophthalmic Optical Contact Lenses Part 1: Vocabulary, Classification and Recommended Labeling Specifications (GB/T 11417.1- 2012, ISO 18369-1:2006, MOD)

3 Terms and Definitions

GB/T 11417.1 as well as the following terms and definitions apply to this document.

4 Methods of hygienic treatment of contact lenses for multiple patients

The ideal hygienic approach to try-on contact lenses is to give them to the same person after one use or to throw them away. If repeated use is required, In the case of using, moist heat sterilization treatment method is better than chemical disinfection method.