YY/T 0719.6-2020Ophthalmic optics—Contact lens care products - Part 6: Guidelines for determination of shelf-life (English PDF)

Foreword

Ophthalmic Optics - Contact Lens Care Products may be divided into the following 11 parts:

--- Part 1: Vocabulary;

--- Part 2: Fundamental Requirements;

--- Part 3: Microbiological Requirements and Test Methods for Products and Regiments for Hygienic Management of Contact;

--- Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date;

--- Part 5: Determination of Physical Compatibility of Contact Lens Care Products with Contact Lens;

--- Part 6: Guidelines for Determination of Shelf-Life;

--- Part 7: Biological Evaluation Test Methods.

--- Part 8: Test Method for Detergent;

--- Part 9: Test Method for Sequestrant;

--- Part 10: Test Method for Disinfectant;

--- Part 11: Test Method for Moisturizing Lubricant.

This Part is Part 6 of Ophthalmic Optics - Contact Lens Care Products.

This Part was drafted as per the rules specified in GB/T 1.1-2009.

This Part replaced YY/T 0719.6-2010 Ophthalmic Optics - Contact Lens Care Products - Part 6: Guidelines for Determination of Shelf-Life (ISO 13212:1999, IDT).

Compared with YY/T 0719.6-2010, this Part has the major technical changes as follows besides the editorial modifications:

--- Modify the Normative References (see Clause 2 of this Edition; Clause 2 of 2010 Edition);

--- Modify the real-time study (see 5.2.2 of this Edition; 5.2.2 of 2010 Edition);

--- Modify the studies under varying storage conditions (see 5.2.3 of this Edition;

5.2.3 of 2010 Edition);

--- Modify the number and nature of the test sample (see 5.3.1 of this Edition; 5.3.1 of 2010 Edition);

--- Modify the Annex A (see Annex A of this Edition; Annex A of 2010 Edition).

This Part equivalently adopts ISO 13212:2014 Ophthalmic Optics - Contact Lens Care Products - Guidelines for Determination of Shelf-Life.

The Chinese documents that have a consistent correspondence with the international documents cited in this Part are as follows:

--- YY/T 0719.3-2009 Ophthalmic Optics - Contact Lens Care Products - Part 3: Microbiological Requirements and Test Methods for Products and Regiments for Hygienic Management of Contact (ISO 14729:2001, MOD);

--- YY/T 0719.4-2009 Ophthalmic Optics - Contact Lens Care Products - Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date (ISO 14730:2000, IDT);

--- GB/T 11417.1-2012 Ophthalmic Optics - Contact Lenses - Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications (ISO 18369-1:2006, MOD).

Please note some contents of this document may involve the patents. The issuing agency of this document shall not assume the responsibility to identify these patents.

1 Scope

This Part of Ophthalmic Optics - Contact Lens Care Products provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.

This International Standard does not address studies designed to obtain information to establish the in-use stability (i.e.: discard date) of contact lens care products.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.

ISO 14729 Ophthalmic Optics - Contact Lens Care Products - Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses

ISO 14730 Ophthalmic Optics - Contact Lens Care Products - Antimicrobial Preservative Efficacy Testing and Guidance on Determining Discard Date

ISO 18369-1 Ophthalmic Optics - Contact Lenses - Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications

3 Terms and Definitions

For the purposes of this document, the terms and definitions given in ISO 18369-1 apply.

4 General Requirements

4.1 The specified shelf-life of the contact lens care product shall be based on the