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YY 0719.4-2009 PDF English

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YY 0719.4-2009: Ophthalmic optics-contact lens care products. Part 4: Antimicrobial preservative efficacy testing and determining discard date
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YY 0719.4-2009English365 Add to Cart 0-9 seconds. Auto-delivery Ophthalmic optics-contact lens care products. Part 4: Antimicrobial preservative efficacy testing and determining discard date Obsolete

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YY 0719.4-2009: Ophthalmic optics-contact lens care products. Part 4: Antimicrobial preservative efficacy testing and determining discard date


---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0719.4-2009
YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.70 C 40 YY/T 0719.4-2009 / ISO 14730:2000 Ophthalmic Optics - Contact Lens Care Products - Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date (ISO 14730:2000 Ophthalmic Optics – Contact Lens Care Products – Antimicrobial Preservative Efficacy Testing and Determining Discard Date, IDT) ISSUED ON: JUNE 16, 2009 IMPLEMENTED ON: DECEMBER 01, 2010 Issued by: State Food and Drug Administration

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 ... 27 Annex F (Informative) Test Organisms from Other Culture Collections ... 32

Foreword

YY 0719 Ophthalmic Optics – Contact Lens Care Products may be divided into the following 7 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. This Part is Part 4 of YY 0719. This Part equivalently adopts ISO 14730:2000 Ophthalmic Optics – Contact Lens Care Products – Antimicrobial Preservative Efficacy Testing and Determining Discard Date. The Annexes A, B, C, D, E, and F of this Standard are informative. This Standard was proposed by and under the jurisdiction of National Technical Subcommittee for Standardization of Medical Optics & Instruments (SAC/TC 103/SC 1). Organization of this Standard: Hangzhou Center for Medical Device Quality Supervision and Testing, State Food and Drug Administration. Chief drafting staffs of this Standard: Chen Jingyun, Yu Haiying, Li Jiazhong, Ma Li, He Tao, and Qi Weiming. Ophthalmic Optics - Contact Lens Care Products - Part 4: Antimicrobial Preservative Efficacy Testing and Determining Discard Date

1 Scope

This Part of YY 0719 specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods to be used for determination of discard date; refers to the informative Annexes B, C, D and E. This Part is applicable to products for up to a 28-day discard date. The Part is not applicable to sterile products packaged in unit doses for single use or multidose containers designed with physical barriers to microbial contamination (e.g.: aerosol containers). NOTE 1: Principles of the test may be used to extend discard dating beyond 28 days. See Annexes B, C, D and E. NOTE 2: Use of multiple or mixed microbial challenges and/or inclusion of contact lenses or other organic load can influence the apparent antimicrobial activity of a particular product. The evaluation of these variables together with testing against a larger panel of microorganisms and testing of samples from partially used containers may be of value in developing a contact lens care product, but are excluded from the scope of this Standard.

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 YY 0719.2 Ophthalmic Optics – Contact Lens Care Products – Part 2: ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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