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YY 0719.2-2009: Ophthalmic optics. Contact lens care products. Part 2: Fundamental requirements
YY 0719.2-2009
Ophthalmic optics.Contact lens care products.Part 2.Fundamental requirements
ICS 11.040.70
C40
People's Republic of China Pharmaceutical Industry Standards
Ophthalmic optical contact lens care products
Part 2.Basic requirements
(ISO 14534..2002 Opthalmics-Contectlinksand
Controllinkscare products-FundamentalreQuirrements, MOD)
2009-06-16 released
2010-12-01 implementation
Issued by the State Food and Drug Administration
Preface
YY 0719 "Ophthalmic Optical Contact Lens Care Products" is divided into 7 parts.
---Part 1.Terminology;
---Part 2.Basic requirements;
---Part 3.Microbiological requirements and test methods and contact lens care system;
---Part 4.Antimicrobial antiseptic effectiveness test and guidelines for determining the date of discarding;
---Part 5.Determination of the physical compatibility of contact lenses and contact lens care products;
---Part 6.Guidelines for determination of validity period;
---Part 7.Biological evaluation test methods.
This part is part 2 of YY 0719.
This part of the revision adopts ISO 14534..2002 "Basic requirements for ophthalmic optical contact lenses and contact lens care products."
The main differences between this part and ISO 14534.2002 are as follows.
---This part only adopts the content of contact lens care products in ISO 14534.2002, and does not involve contact lens and contact
Safety and performance requirements of other accessories of the mirror;
---Added part of ISO 11978.2000 related to the content of the information that the manufacturer should provide.
This part is redrafted in accordance with ISO 14534.2002.The chapter number and the number of this part are listed in Appendix A (informative appendix).
ISO 14534.A comparison list of.2002 chapter numbers.
In consideration of my country’s national conditions and the needs of this part, when ISO 14534.2002 is adopted, this part has been modified. The relevant technical differences have been compiled.
Enter the text, and mark with a vertical single line (│) in the margins of the terms they refer to. These are given in Appendix B (informative appendix)
A list of technical differences and their reasons is for reference.
This part is proposed and managed by the National Standardization Subcommittee of Medical Optics and Instruments (SAC/TC103/SC1).
Drafting organization of this section. Hangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
The main drafters of this section. Chen Jingyun, He Tao, Ma Li, Jia Xiaohang, Li Jiazhong, Qi Weiming, Wen Yan, Yu Hairong, Chen Xianhua, Jiang Xiaolu.
Ophthalmic optical contact lens care products
Part 2.Basic requirements
1 Scope
This part of YY 0719 specifies the safety and performance requirements for contact lens care products.
This section does not make any provisions on electrical safety and electromagnetic compatibility caused by electrical products used at the same time as contact lens care products.
2 Normative references
The clauses in the following documents become clauses of this part through the quotation of YY 0719.For dated reference documents, its
All subsequent amendments (not including errata content) or revisions do not apply to this section, however, it is encouraged to reach an agreement based on this section
The parties shall study whether the latest versions of these documents can be used. For undated reference documents, the latest version is applicable to this section.
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing (GB/T 16886.1-2001, idt
ISO 10993-1..1997)
GB 19192-2003 Hygienic standard for contact lens care solution
YY/T 0287 Medical device quality management system is used in regulatory requirements (YY/T 0287-2003, ISO 13485..2003,
IDT)
YY/T 0297 Clinical Evaluation of Medical Devices (YY/T 0297-1997, idt ISO 14155..1996)
YY/T 0316 Medical Device Risk Management Applied to Medical Devices (YY/T 0316-2003, idt ISO 14971.2000)
YY 0719.1 Terminology of ophthalmic optical contact lens care products
YY 0719.3 Microbiological requirements and test methods for ophthalmic optical contact lens care products and contact lens care system (YY 02990.3-
2008, ISO 11799-3.2006, IDT)
YY 0719.4 Guidelines for the anti-microbial anti-corrosion effectiveness test and determination of the date of disposal of ophthalmic optical contact lens care products
(YY 0290.4-2009, ISO 14730..2000, IDT)
YY 0719.5 Ophthalmic optical contact lens care products. Determination of the physical compatibility of contact lenses and contact lens care products
(YY 02905-2008, ISO 111979-5.2006, MOD)
YY 0719.6 Guidelines for determining the expiration date of ophthalmic optical contact lens care products (YY 0290.6-2009, ISO 111979-6.
2007, IDT)
YY 0719.7 Biological evaluation test method for ophthalmic optical contact lens care products 1)
The Pharmacopoeia of the People's Republic of China (2005) Two
ISO 11978..2000 Information provided by manufacturers of ophthalmic optical contact lenses and contact lens care products
3 Terms and definitions
The terms and definitions established by YY 0719.1 apply to this part of YY 0719.
1) Coming soon.
4 Product Categories
4.1 According to product function, contact lens care products can be divided into. physiological saline, cleaning agent (daily cleaning agent and regular cleaning agent), contact lens chemistry
Disinfection products (including conditioning fluids for hydrophobic contact lenses), multifunctional fluids, eye drops for contact lenses (such as lubricating fluids and/or eye drops), but not limited to
These few types of products.
4.2 According to the method of product use, contact lens care products can be divided into direct use products and indirect use after treatment (if neutralization is required)
product.
4.3 According to the product form, contact lens care products can be divided into liquid products and solid products.
4.4 According to the product dosage, contact lens care products can be divided into multiple-dose products and single-dose products.
4.5 According to whether the product is in direct contact with human eyes, contact lens care products can be divided into direct contact with human eyes and non-direct contact with human eyes.
5 Safety and performance
5.1 The manufacturer's intended purpose of contact lens care products should be documented.
5.2 The manufacturer shall prove the performance of contact lens care products through the evaluation of existing information and human application history. If necessary, use clinical
Pre-trial and clinical trials. In order to evaluate the safety and performance of contact lens care products, the following aspects should be considered and documented.
a) Functional characteristics, intended purpose and conditions of use;
b) Physical and chemical properties. such as appearance, pH value, osmotic pressure, viscosity, dissolution time, neutralization time, loading (volume/weight), contact lens care
The physical compatibility of the product and the contact lens, the main active ingredients, the residual amount of hydrogen peroxide, and other things such as cleaning efficiency (see
Chapter 11);
c) Microbial characteristics, including bioburden, sterility, antimicrobial activity (disinfection effect) and antiseptic effectiveness (see Chapter 12);
d) Biological evaluation, including cytotoxicity, irritation, sensitization and oral toxicity (see Chapter 13);
e) Clinical evaluation (see Chapter 9);
f) Stability, including expiry date and discard date (see Chapter 15).
5.3 In the absence of corresponding standards, the manufacturer shall use valid scientific evidence to prove that the contact lens care product meets the claimed characteristics
This evidence comes from laboratory and/or clinical research.
Note. According to the requirements of YY/T 0287, the manufacturer shall maintain its traceability.
6 Risk analysis
6.1 The manufacturer shall conduct a complete risk analysis of each contact lens care product in accordance with the requirements of YY/T 0316.
6.2 In the following cases, the manufacturer shall re-analyze and evaluate each risk.
a) Regularly;
b) When there is any change in the contact lens care product or its production process;
c) When there are any changes to packaging and labels;
d) When the manufacturer learns of relevant new information.
7 Design
The manufacturer shall design in accordance with the requirements of YY/T 0287 to verify that the contact lens care product can achieve all the results when used for its intended purpose.
Required performance and safety.
8 Materials
The manufacturer should select the contact based on the necessary characteristics such as safety, performance, production, handling and compatibility with other materials that may be exposed to it.
Manufacturing material for mirror care products.
The reasons for selecting materials should be documented.
9 Clinical evaluation
Manufacturers use one or more of the following methods to assess the safety and/or performance of the contact lens care product according to the intended purpose of the product.
Clinical evaluation.
a) A compilation of current scientific and technological literature on the intended purpose, performance and evaluation techniques of relevant contact lens care products;
b) Past use experience;
c) Clinical research.
Clinical research should be conducted in accordance with the relevant regulations of YY/T 0297.
10 Manufacturing
The control of the manufacturing process should be documented to ensure the required quality of contact lens care products. Contact lens care products should fully meet the design
The quality requirements specified in the design documents or contact lens care product specifications. Contact lens care products should meet the required chemical, physical and biological
The level of parameters, especially those that may adversely affect the safety of operators and users, as well as the functionality and reliability of the product.
Regarding particulate and microbial contamination.
11.Physical and chemical requirements
11.1 Appearance
It shall comply with the product characteristics requirements of the contact lens care products specified by the manufacturer, and shall be approved in accordance with the Pharmacopoeia of the People’s Republic of China (2005).
Appendices to the corresponding method of inspection.
The original solution of liquid contact lens care products and the use liquid of solid contact lens care products, the medium of contact lens care products containing hydrogen peroxide
And the product should conform to the pH value range specified by the manufacturer, and pass the pH value measurement according to the second appendix of the Pharmacopoeia of the People’s Republic of China (2005)
Determination of the method".
11.3 Osmotic pressure
The original solution or use solution of contact lens care products that directly contact human eyes, and the neutralized product of contact lens care products containing hydrogen peroxide shall comply with
Compliance with the range of osmotic pressure (unit. mOsm/kg) specified by the manufacturer, and approved in accordance with the second appendix of the Pharmacopoeia of the People’s Republic of China (2005)
Determination of osmolality.
11.4 Viscosity
Liquid contact lens care products, if necessary, should meet the viscosity parameter range specified by the manufacturer. And passed the
"The Code" (2005) two appendix "Viscosity determination method" determination.
11.5 Dissolution time
For solid contact lens care products that need to be used after dissolution, the dissolution time should be specified and checked by the appropriate test methods given.
11.6 Neutralization time
For contact lens care products with neutralizing effect, the neutralization time should be specified and passed the inspection by the appropriate test method given.
11.7 Packing quantity (volume/weight)
It shall meet the volume/weight range of liquid/solid contact lens care products specified by the manufacturer, and shall be approved in accordance with the "Pharmaceuticals of the People's Republic of China".
"Code" (2005) two appendix "Minimum loading inspection method" inspection.
11.8 Physical compatibility with contact lenses
The physical compatibility of contact lens care products and contact lenses should meet the requirements of YY 0719.5.
11.9 Active ingredients
Contact lens care products should comply with the main active ingredient content range indicated by the manufacturer’s trademark, and use direct analysis methods or appropriate substitutes
Method for detection.
11.10 Residual hydrogen peroxide
For contact lens care products containing hydrogen peroxide, the residual amount of hydrogen peroxide in the neutralized product should be ≤30mg/kg.
11.11 Cleaning efficiency
Manufacturers should verify and document contact lens care products with cleaning effects (such as protein removal, etc.).
Note. Enzyme cleaner can be determined by measuring enzyme activity.
12 Microbiological requirements
12.1 The manufacturing and packaging process of contact lens care products that do not directly contact human eyes should ensure that the average bioburden of the products is low during the validity period.
At 100 CFU/g (CFU/mL), it should not contain pathogenic bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa and E. coli. Bioburden can be
The "Microbial Limit Inspection Method" in the second appendix of the Pharmacopoeia of the People’s Republic of China (2005) shall be inspected. Pathogenic bacteria can be inspected according to the
"Code" (2005) two appendix related methods to be checked.
12.2 Liquid contact lens care products that directly contact human eyes should be sterile products. Sterile contact lens care products can be terminally sterilized products
Products (SAL is 10-6 or lower), or they can be aseptically formulated products according to validated and proven procedures. Sterility check can be clicked
The "Sterile Test Method" in the second appendix of the Pharmacopoeia of the People's Republic of China (2005) was carried out.
12.3 The contact lens care products used in multiple doses should have antiseptic properties during the expiration date indicated and...