YY 0719.4-2009Ophthalmic optics - Contact lens care products - Part 4: Guidelines for antimicrobial preservative efficacy testing and determination of discard date (English PDF)

眼科光学接触镜护理产品第4部分：抗微生物防腐有效性试验及测定抛弃日期指南

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

August 25, 2023

Implementation date

December 1, 2010

Scope

YY 0719.4-2009 is the English-translated version of 眼科光学接触镜护理产品第4部分：抗微生物防腐有效性试验及测定抛弃日期指南.

YY 0719.4 covers how the preservative in a contact lens care product is shown to work, and how the discard date after opening is determined. A bottle of lens solution is opened, handled with unwashed fingers and used for weeks, so the preservative system is what stands between the user and a contaminated solution introduced directly onto the cornea. Acanthamoeba and Pseudomonas keratitis from contaminated solutions cause sight loss. This part sets out the antimicrobial preservative efficacy testing: the challenge organisms, the inoculation and recovery, and how the results establish the period the product stays safe once opened. Being a YY standard without the /T suffix, compliance is compulsory in China. The standard carries Amendment 1 of 2023.

Document preview — YY 0719.4-2009

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA ICS

YY/T 0719.4-2009 / ISO 14730:2000

Ophthalmic Optics - Contact Lens Care Products -Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date

32 Table of Contents Foreword.......................................................................................................... 3

1 Scope............................................................................................................ 4

2 Normative References .................................................................................. 4

3 Terms and Definitions ................................................................................... 5

4 Principle ........................................................................................................ 5

5 Test Methods ................................................................................................

5 Annex A (Informative) Example of a Membrane Filtration Procedure ............

12 Annex B (Informative) Discard Date Procedure I ...........................................

15 Annex C (Informative) Discard Date Procedure II ..........................................

19 Annex D (Informative) Discard Date Procedure III .........................................

24 Annex E (Informative) Discard Date Procedure IV .........................................

2 Normative References

The provisions in following documents become the provisions of this Part of

YY 0719 through reference in this Part. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Part, however, parties who reach an agreement based on this Part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.

YY 0719.1 Ophthalmic Optics - Contact Lens Care Products - Part 1: Vocabulary

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

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