YY 0719.4-2009 PDF in English
YY 0719.4-2009 (YY0719.4-2009) PDF English
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YY 0719.4-2009 | English | 365 |
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 |
Standards related to (historical): YY 0719.4-2009
PDF Preview
YY 0719.4-2009: PDF in English YY/T 0719.4-2009 (Renamed from YY 0719.4-2009)
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 PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
|