YY 0719.6-2010 English PDF

YY 0719.6-2010: Ophthalmic optics. Contact lens care products. Part 6: Guidelines for determination of shelf-life
Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Newer version: (Replacing this standard) YY/T 0719.6-2020
Get Quotation: Click YY 0719.6-2010 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0719.6-2020
Preview True-PDF (Reload/Scroll-down if blank)


YY/T 0719.6-2010 (Renamed from YY 0719.6-2010)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.6-2010 / ISO 13212:1999
Ophthalmic Optics - Contact Lens Care Products -
Part 6: Guidelines for Determination of Shelf-Life
(ISO 13212:1999 Ophthalmic Optics - Contact Lens Care Products -
Guidelines for Determination of Shelf-Life, IDT)
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
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 Requirements ... 5
5 Determination of Finished Product Stability ... 5
Annex (informative) Example of Stability-Testing Plan for a Finished Contact
Lens Care Product ... 11
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 6 of YY 0719.
This Part equivalently adopts ISO 13212:1999 Ophthalmic Optics – Contact Lens Care
Products – Guidelines for Determination of Shelf-Life (English Version).
The Annex A of this Standard is informative.
This Standard was proposed by and under the jurisdiction of National Technical
Subcommittee for Standardization of Medical Optics and 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, Zhang Li, He Tao, Qi Weiming, Li
Jiazhong, and Yu Haiying.
Ophthalmic Optics - Contact Lens Care Products -
Part 6: Guidelines for Determination of Shelf-Life
1 Scope
This Part of YY 0719 provides guidance on the design of stability studies to use in
gathering information to allow determination of shelf-life of contact lens care products.
This Part does not address studies designed to obtain information to establish the in-
use stability (i.e.: discard statement) of contact lens care products.
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 0719.1-2009, ISO 18369-1:2006, NEQ)
YY 0719.2 Ophthalmic Optics – Contact Lens Care Products – Part 2:
Fundamental Requirements (YY 0719.2-2009, ISO 14534:2002, MOD)
YY 0719.3 Ophthalmic Optics – Contact Lens Care Products – Part 3:
Microbiological Requirements and Test Methods for Products and Regiments for
Hygienic Management of Contact (YY 0719.3-2009, ISO 14729:2001, MOD)
YY 0719.4 Ophthalmic Optics – Contact Lens Care Products – Part 4:
Antimicrobial Preservative Efficacy Testing and Determining Discard Date (YY
0719.4-2009, ISO 14730:2000, IDT)
YY 0719.5 Ophthalmic Optics – Contact Lens Care Products – Part 5:
Determination of Physical Compatibility of Contact Lens Care Products with
Contact Lens (YY 0719.5-2009, ISO 11981:1999, MOD)
YY/T 0719.6-2010 (Renamed from YY 0719.6-2010)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.6-2010 / ISO 13212:1999
Ophthalmic Optics - Contact Lens Care Products -
Part 6: Guidelines for Determination of Shelf-Life
(ISO 13212:1999 Ophthalmic Optics - Contact Lens Care Products -
Guidelines for Determination of Shelf-Life, IDT)
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
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 Requirements ... 5
5 Determination of Finished Product Stability ... 5
Annex (informative) Example of Stability-Testing Plan for a Finished Contact
Lens Care Product ... 11
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 6 of YY 0719.
This Part equivalently adopts ISO 13212:1999 Ophthalmic Optics – Contact Lens Care
Products – Guidelines for Determination of Shelf-Life (English Version).
The Annex A of this Standard is informative.
This Standard was proposed by and under the jurisdiction of National Technical
Subcommittee for Standardization of Medical Optics and 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, Zhang Li, He Tao, Qi Weiming, Li
Jiazhong, and Yu Haiying.
Ophthalmic Optics - Contact Lens Care Products -
Part 6: Guidelines for Determination of Shelf-Life
1 Scope
This Part of YY 0719 provides guidance on the design of stability studies to use in
gathering information to allow determination of shelf-life of contact lens care products.
This Part does not address studies designed to obtain information to establish the in-
use stability (i.e.: discard statement) of contact lens care products.
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 0719.1-2009, ISO 18369-1:2006, NEQ)
YY 0719.2 Ophthalmic Optics – Contact Lens Care Products – Part 2:
Fundamental Requirements (YY 0719.2-2009, ISO 14534:2002, MOD)
YY 0719.3 Ophthalmic Optics – Contact Lens Care Products – Part 3:
Microbiological Requirements and Test Methods for Products and Regiments for
Hygienic Management of Contact (YY 0719.3-2009, ISO 14729:2001, MOD)
YY 0719.4 Ophthalmic Optics – Contact Lens Care Products – Part 4:
Antimicrobial Preservative Efficacy Testing and Determining Discard Date (YY
0719.4-2009, ISO 14730:2000, IDT)
YY 0719.5 Ophthalmic Optics – Contact Lens Care Products – Part 5:
Determination of Physical Compatibility of Contact Lens Care Products with
Contact Lens (YY 0719.5-2009, ISO 11981:1999, MOD)