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

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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.

Basic Data

Standard ID	YY 0719.4-2009 (YY0719.4-2009)
Description (Translated English)	Ophthalmic optics-contact lens care products. Part 4: Antimicrobial preservative efficacy testing and determining discard date
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.70
Word Count Estimation	22,250
Date of Issue	2009-06-16
Date of Implementation	2010-12-01
Quoted Standard	YY 0719.1; YY 0719.2
Adopted Standard	ISO 14730-2000, IDT
Regulation (derived from)	Industry standard filing Notice 2009 No. 9
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the amount of preservative used to evaluate all times contact lens care products, anti-microbial preservative effect of operating procedures, and gives guidelines for the determination of the date of abandoned, see informative Annex B, Annex C, Appendix D and Appendix E. This section can be used to date is 28 d disposable products. This section does not apply to an amount of disposable packaging sterile products or the use of physical barriers many times the amount of anti-microbial contamination of containers (such as aerosol containers).