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

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,

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.:

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