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YY/T 0719.5-2022: Ophthalmic optics - Contact lens care products - Part 5: Determination of physical compatibility of contact lens care products with contact lenses
Status: Valid YY/T 0719.5: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0719.5-2022 | English | 259 |
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Ophthalmic optics - Contact lens care products - Part 5: Determination of physical compatibility of contact lens care products with contact lenses
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YY/T 0719.5-2022
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| YY 0719.5-2009 | English | 155 |
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Ophthalmic optics. Contact lens care products. Part 5: Determination of physical compatibility of contact lens care products with contact lenses [YY/T 0719.5-2009]
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Basic data | Standard ID | YY/T 0719.5-2022 (YY/T0719.5-2022) | | Description (Translated English) | Ophthalmic optics - Contact lens care products - Part 5: Determination of physical compatibility of contact lens care products with contact lenses | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Word Count Estimation | 12,128 | | Issuing agency(ies) | State Drug Administration | YY/T 0719.5-2022: Ophthalmic optics - Contact lens care products - Part 5: Determination of physical compatibility of contact lens care products with contact lenses
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Ophthalmic optics - Contact lens care products - Part 5.Determination of physical compatibility of contact lens care products with contact lenses
ICS 11.040.70
CCSC40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0719.5-2009
Ophthalmic Contact Lens Care Products
Part 5.Contact lenses and contact lens care products
Determination of Physical Compatibility
(ISO 11981.2017, Ophthalmicoptics-Contactlenscare
2022-05-18 Released 2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Principle 2
5 Selection of trial lenses 2
6 Step 4
7 Test report 5
Reference 6
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 5 of YY/T 0719 "Ophthalmic Contact Lens Care Products". YY/T 0719 has issued the following
part.
--- Part 1.Terminology;
--- Part 2.Basic requirements;
--- Part 3.Microbiological requirements and test methods and contact lens care systems;
--- Part 4.Guidelines for testing the effectiveness of antimicrobial preservatives and determining the date of disposal;
--- Part 5.Determination of the physical compatibility of contact lenses with contact lens care products;
--- Part 6.Guidelines for Determination of Validity Period;
--- Part 7.Test methods for biological evaluation;
--- Part 8.Determination of cleaning agents.
This document replaces YY/T 0719.5-2009 "Ophthalmic Optical Contact Lens Care Products Part 5.Contact Lenses and Contact Lens Care Products
"Determination of Physical Compatibility of Products", compared with YY/T 0719.5-2009, the main technical changes other than editorial changes are as follows.
--- Changed the "normative references" (see Chapter 2, Chapter 2 of the.2009 edition);
--- Changed the "term" (see Chapter 3, Chapter 3 of the.2009 edition);
--- Changed the "principle" (see Chapter 4, Chapter 4 of the.2009 edition);
--- Changed "Selection of test lenses" (see 5.2, 5.2 of the.2009 edition);
--- Changed the "step" (see Chapter 6, Chapter 6 of the.2009 edition);
--- Changed the "Test Report" (see Chapter 7, Chapter 7 of the.2009 edition).
This document uses the redrafted method to amend ISO 11981.2017 "Ophthalmic Optical Contact Lens Care Products Contact Lenses and Contact Lenses"
Determination of Physical Compatibility of Care Products".
There are technical differences between this document and ISO 11981.2017, and these differences involve clauses that have been
Placed vertical single line (|) is marked.
The technical differences between this document and ISO 11981.2017 and the reasons are as follows.
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The specific situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.
● Use the modified GB/T 11417.1-2012 of the international standard and the non-equivalent YY/T 0719.1 generation of the international standard
Replace ISO 18369-1.2017;
● Replace ISO 18369-3.2017 with the non-equivalent GB/T 11417.5 which adopts the international standard;
● Added reference to GB 11417.2;
● Added reference to GB 11417.3;
● Added reference to GB/T 11417.6;
● Removed ISO 18369-2.
--- Changed the unit of nominal osmotic pressure in the term and definition "standard salt solution" (see 3.2), because the international standard unit is incorrectly expressed
error, so the unit of nominal osmolality was changed.
--- Changed the selection of contact lens materials by the test group (see 5.2) to adapt to the technical conditions of our country.
The following editorial changes have been made to this document.
--- Changed the standard name;
--- Changed references.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is sponsored by the Medical Optics and Instruments Subcommittee of the National Optical and Photonics Standardization Technical Committee (SAC/TC103/
SC1) focal point.
This document is drafted by. Zhejiang Medical Device Inspection and Research Institute.
The main drafters of this document. Yan Qinglai, Fang Hongping, Tao Yewen, Ru Zhoufeng, Zhu Yaqi, Zou Dan.
The previous versions of the documents replaced by this document are as follows.
---YY/T 0719.5-2009.
Introduction
YY/T 0719 aims to evaluate the safety and effectiveness of contact lens care products, and is intended to consist of 11 parts.
--- Part 1.Terminology.
--- Part 2.Basic requirements.
--- Part 3.Microbiological requirements and test methods and contact lens care systems.
--- Part 4.Guidelines for testing the effectiveness of antimicrobial preservatives and determining the date of disposal.
--- Part 5.Determination of physical compatibility of contact lenses with contact lens care products.
--- Part 6.Guidelines for the determination of validity period.
--- Part 7.Biological evaluation test methods.
--- Part 8.Determination of cleaning agents.
--- Part 9.Determination of chelating agents.
--- Part 10.Determination of disinfectants.
--- Part 11.Determination of moisturizing lubricants.
Ophthalmic Contact Lens Care Products
Part 5.Contact lenses and contact lens care products
Determination of Physical Compatibility
1 Scope
This document specifies the general procedures and performance requirements for evaluating the physical compatibility of contact lenses and contact lens care products, as well as the determination of observed
Whether the lens changes are reversible.
This document applies to the determination of the physical compatibility test of contact lens care products.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 11417.1-2012 Ophthalmic Optical Contact Lenses Part 1.Vocabulary, Classification and Recommended Labeling Specifications (ISO 18369-
1.2006, MOD)
GB 11417.2 Ophthalmic Optical Contact Lenses Part 2.Rigid Contact Lenses
GB 11417.3 Ophthalmic Optical Contact Lenses Part 3.Soft Contact Lenses
GB/T 11417.5 Ophthalmic Optical Contact Lenses-Part 5.Test Methods for Optical Properties (GB/T 11417.5-2012,
ISO 18369-3.2006, NEQ)
GB/T 11417.6 Ophthalmic Optical Contact Lenses Part 6.Test Methods for Mechanical Properties
YY/T 0719.1 Ophthalmic Optical Contact Lens Care Products Part 1.Terminology (YY/T 0719.1-2009, ISO 18369-1.
2006, NEQ)
3 Terms and Definitions
The terms and definitions defined in GB/T 11417.1-2012, YY/T 0719.1 and the following apply to this document.
3.1
cycle operation cycle
Follow the directions for use or recommendations provided by the contact lens care product manufacturer, after removing the contact lens and before putting it back on.
A series of nursing steps carried out during the period.
3.2
Special phosphate buffer solution with pH value of 7.4±0.1 (nominal osmolality. 310mOsm/kg±5mOsm/kg).
Note. Please refer to GB/T 11417.4 for the formula and preparation regulations of standard salt solution.
3.3
control solution
Standard saline solution or suitable alternative solution in contact lens cycle operation.
Note. The control solution does not need to fully comply with this document, it can be used to obtain more test-related information.
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