YY 0719.5-2009 English PDF (YY0719.5-2009)

This part of YY 0719 gives the general steps and performance requirements for determination of physical compatibility of contact lens care products with contact lenses, determining whether the observed lens changes are reversible.

YY/T 0719.5-2009 (Renamed from YY 0719.5-2009)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.5-2009
Ophthalmic optics - Contact lens care products - Part
5: Determination of physical compatibility of contact
lens care products with contact lenses
(ISO 11981:1999:2005 Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses, MOD)
ISSUED ON: JUNE 16, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Principle ... 6
5 Selection of test lens ... 8
6 Steps ... 8
7 Test report ... 10
Foreword
YY 0719 “Ophthalmic optics - Contact lens care products” consists of the following 7 parts:
- Part 1: Vocabulary;
- Part 2: Fundamental requirements;
- Part 3: Microbiological requirements and test methods for products and regimens 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 lenses;
- Part 6: Guidelines for determination of shelf-life;
- Part 7: Biological evaluation test methods.
This Part is Part 5 of YY 0719.
This Part is revised based on the adoption of ISO 11981:1999+Corl: 2005 “Ophthalmic optics - Contact lenses and contact lens care products -
Determination of physical compatibility of contact lens care products with contact lenses”.
The differences between this Part and ISO 11981 are as follows:
1) Added the term and definition for contact lens related to this Part; 2) In indicator references, deleted abolished standards and replaced by currently valid standards.
This Part was proposed by and shall be under the jurisdiction of National Technical Committee for Medical Optics and Instrument Standardization (SAC TC 103/SC 1).
The drafting organizations of this Part: Hangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration. Main drafters of this Part: Wen Yan, Jia Xiaohang, He Tao, Qi Weiming, Lu Xiaochun.
Ophthalmic optics - Contact lens care products - Part
5: Determination of physical compatibility of contact
lens care products with contact lenses
1 Scope
This Part of YY 0719 provides general steps to evaluate the physical
compatibility of contact lenses and contact lens care products AND
performance requirements as well as determines whether the observed lens changes are reversible.
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 0719.1-2009, Ophthalmic optics - Contact lens care products - Part 1: Vocabulary
ISO 18369-1:2006, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 18369-2:2006, Ophthalmic optics - Contact lenses - Part 2: Tolerances ISO 18369-3:2006, Ophthalmic optics - Contact lenses - Part 3:
Measurement methods
3 Terms and definitions
The following terms and definitions apply to this Part of YY 0719.
3.1 cycle
sequence of events, following instructions for use or recommendations by the