YY/T 0719.6-2020 English PDF (YYT0719.6-2020)

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YY/T 0719.6-2020: Ophthalmic optics -- Contact lens care products -- Part 6: Guidelines for determination of shelf-life
YY/T 0719.6-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.6-2020 / ISO 13212:2014
Replacing YY/T 0716.9-2010
Ophthalmic Optics - Contact Lens Care Products -
Part 6: Guidelines for Determination of Shelf-Life
(ISO 13212:2014 Ophthalmic Optics - Contact Lens Care Products -
Guidelines for Determination of Shelf-Life, IDT)
ISSUED ON: JUNE 30, 2020
IMPLEMENTED ON: JUNE 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 5
4 General Requirements ... 5
5 Determination of Finished Product Stability ... 6
Annex A (informative) Example of a Stability Testing Plan for the Finished
Contact Lens Care Product ... 12
Bibliography ... 13
Foreword
Ophthalmic Optics – Contact Lens Care Products may be divided into the following 11
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.
--- Part 8: Test Method for Detergent;
--- Part 9: Test Method for Sequestrant;
--- Part 10: Test Method for Disinfectant;
--- Part 11: Test Method for Moisturizing Lubricant.
This Part is Part 6 of Ophthalmic Optics – Contact Lens Care Products.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part replaced YY/T 0719.6-2010 Ophthalmic Optics – Contact Lens Care
Products – Part 6: Guidelines for Determination of Shelf-Life (ISO 13212:1999, IDT).
Compared with YY/T 0719.6-2010, this Part has the major technical changes as
follows besides the editorial modifications:
--- Modify the Normative References (see Clause 2 of this Edition; Clause 2 of 2010
Edition);
--- Modify the real-time study (see 5.2.2 of this Edition; 5.2.2 of 2010 Edition);
--- Modify the studies under varying storage conditions (see 5.2.3 of this Edition;
5.2.3 of 2010 Edition);
--- Modify the number and nature of the test sample (see 5.3.1 of this Edition; 5.3.1
of 2010 Edition);
--- Modify the Annex A (see Annex A of this Edition; Annex A of 2010 Edition).
This Part equivalently adopts ISO 13212:2014 Ophthalmic Optics – Contact Lens Care
Products – Guidelines for Determination of Shelf-Life.
The Chinese documents that have a consistent correspondence with the international
documents cited in this Part are as follows:
--- YY/T 0719.3-2009 Ophthalmic Optics – Contact Lens Care Products – Part 3:
Microbiological Requirements and Test Methods for Products and Regiments for
Hygienic Management of Contact (ISO 14729:2001, MOD);
--- YY/T 0719.4-2009 Ophthalmic Optics – Contact Lens Care Products – Part 4:
Antimicrobial Preservative Efficacy Testing and Determining Discard Date (ISO
14730:2000, IDT);
--- GB/T 11417.1-2012 Ophthalmic Optics - Contact Lenses - Part 1: Vocabulary,
Classification System and Recommendations for Labeling Specifications (ISO
18369-1:2006, MOD).
Please note some contents of this document may involve the patents. The issuing
agency of this document shall not assume the responsibility to identify these patents.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Subcommittee for
Standardization of Medical Optics and Instruments (SAC/TC 103/SC 1).
Drafting organization of this Part: Zhejiang Institute for the Control of Medical Device.
Chief drafting staffs of this Part: Chen Jingyun, Zhang Li, He Tao, Qi Weiming, Lu Xin,
Ding Yichen, and Hu Meili.
The historical edition replaced by this Standard is as follows:
--- YY/T 0719.6-2010.
Ophthalmic Optics - Contact Lens Care Products -
Part 6: Guidelines for Determination of Shelf-Life
1 Scope
This Part of Ophthalmic Optics – Contact Lens Care Products provides guidance on
the design of stability studies for use in gathering information to enable determination
of the shelf-life of contact lens care products.
This International Standard does not address studies designed to obtain information
to establish the in-use stability (i.e.: discard date) of contact lens care products.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document.
ISO 14729 Ophthalmic Optics – Contact Lens Care Products – Microbiological
Requirements and Test Methods for Products and Regimens for Hygienic
Management of Contact Lenses
ISO 14730 Ophthalmic Optics – Contact Lens Care Products – Antimicrobial
Preservative Efficacy Testing and Guidance on Determining Discard Date
ISO 18369-1 Ophthalmic Optics – Contact Lenses – Part 1: Vocabulary,
Classification System and Recommendations for Labeling Specifications
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 18369-1
apply.
4 General Requirements
4.1 The specified shelf-life of the contact lens care product shall be based on the