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YY 0719.2-2009: Ophthalmic optics. Contact lens care products. Part 2: Fundamental requirements
YY/T 0719.2-2009 (Renamed from YY 0719.2-2009)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
YY/T 0719.2-2009
Ophthalmic optics - Contact lens care products -
Part 2: Fundamental requirements
(ISO 14534:2002 Ophthalmic optics - Contact lenses and contact lens care
products - Fundamental requirements, 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 ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Product classification ... 6 
5 Safety and performance ... 7 
6 Risk analysis ... 7 
7 Design ... 8 
8 Material ... 8 
9 Clinical evaluation ... 8 
10 Manufacturing ... 8 
11 Physical and chemical requirements ... 9 
12 Microbiological requirements ... 10 
13 Biological evaluation ... 11 
14 Packaging ... 11 
15 Validity period and discard date ... 12 
16 Labels and information provided by the manufacturer ... 12 
Appendix A (Informative) A list of comparisons of the chapter number between
this part and YS 14534:2002 ... 15 
Appendix B (Informative) The technical difference between this part and ISO
14534:2002 and the reasons ... 17 
Ophthalmic optics - Contact lens care products -
Part 2: Fundamental requirements
1 Scope
This part of YY 0719 specifies the safety and performance requirements for
contact lens care products.
This part does not make any provisions on electrical safety and electromagnetic
compatibility caused by electrical products used simultaneously with contact
lens care products.
2 Normative references
The provisions in following documents become the provisions of this part
through reference in this part of YY 0719. For the dated references, the
subsequent amendments (excluding corrections) 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.
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 requirement for contact lens care solution
YY/T 0287 Medical devices - Quality management systems -
Requirements for regulatory purposes (YY/T 0287-2003, ISO 13485:2003,
IDT)
YY/T 0297 Clinical investigation of medical devices (YY/T 0297-1997, idt
ISO 14155:1996)
YY/T 0316 Medical devices - Application of risk management to medical
devices (YY/T 0316-2003, idt ISO 14971:2000)
YY 0719.1 Ophthalmic optics - Contact lens care products - Part 1:
Vocabulary
YY 0719.3 Ophthalmic optics - Contact lens care products - Part 3:
Microbiological requirements and test methods for products and regimens
for hygienic management of contact (YY 0290.3-2008, ISO 11979-3:2006,
IDT)
YY 0719.4 Ophthalmic optics - Contact lens care products - Part 4:
Antimicrobial preservative efficacy testing and determining discard date (YY
0290.4-2009, 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 lenses (YY 0290.5-2008, ISO11979-5:2006, MOD)
YY 0719.6 Ophthalmic optics - Contact lens care products - Part 6:
Guidelines for determination of shelf-life (YY 0290.6-2009, ISO 11979-
6:2007, IDT)
YY 0719.7 Ophthalmic optics - Contact lens care products - Part 7: Biological
evaluation test methods 1)
The Pharmacopoeia of the People's Republic of China (2005), Part 2
ISO 11978:2000 Ophthalmic optics - Contact lenses and contact lens care
products - Information supplied by the manufacturer
3 Terms and definitions
The terms and definitions established in YY 0719.1 apply to this part of YY 0719.
4 Product classification
4.1 According to product functions, contact lens care products can be divided
into: physiological saline, cleaning agents (daily cleaning agents and regular
cleaning agents), contact lens chemical disinfection products (including
hydrophobic contact lens conditioning solutions), multifunctional liquids, eye
drops for contact lenses (such as lubricants and/or eye drops), but not limited
to these 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 products that require treatment
(e.g., neutralization is required).
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 multi-dose products and unit dose products.
1 It will be published soon.
required quality of contact lens care products. Contact lens care products shall
fully meet the quality requirements specified in the design documents or contact
lens care product specifications. Contact lens care products shall meet the
required levels of chemical, physical and biological parameters, especially
those related particulate and microbial contamination that may adversely affect
the safety of operators and users, as well as the functionality and reliability of
the product.
11 Physical and chemical requirements
11.1 Appearance
It shall meet the requirements of the product properties of the contact lens care
products as specified by the manufacturer; pass the inspection according to the
corresponding method in the Appendix of the Pharmacopoeia of the People's
Republic of China (2005), part 2.
11.2 pH value
The original liquid of liquid contact lens care products and the use liquid of solid
contact lens care products, as well as the neutralized products of contact lens
care products containing hydrogen peroxide shall meet the pH value range
specified by the manufacturer; pass the determination according to the "pH
value determination method" in the Appendix of the Pharmacopoeia of the
People's Republic of China (2005), part 2.
11.3 Osmotic pressure
The original solution or use solution of contact lens care products that directly
contact the human eye, as well as the neutralized product of contact lens care
products containing hydrogen peroxide shall meet the osmotic pressure (unit:
mOsm/kg) specified by the manufacturer; pass the determination according to
the "osmolality determination method" in the Appendix of the Pharmacopoeia
of the People's Republic of China (2005), part 2.
11.4 Viscosity
Liquid contact lens care products, if necessary, shall meet the viscosity
parameter range specified by the manufacturer; pass the determination
according to the "Viscosity determination method" in the Appendix of the
Pharmacopoeia of the People's Republic of China (2005), part 2.
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 checked by the appropriate test methods given.
11.7 Loading (volume/weight)
It shall comply with the volume/weight range of liquid/solid contact lens care
products as specified by the manufacturer; pass the inspection in accordance
with the "Minimum loading inspection method" in the Appendix of the
Pharmacopoeia of the People's Republic of China (2005), part 2.
11.8 Physical compatibility with contact lenses
The physical compatibility of contact lens care products and contact lenses
shall meet the requirements of YY 0719.5.
11.9 Active ingredients
Contact lens care products shall meet the main active ingredient content range
as indicated by the manufacturer's trademark, be tested by direct analysis
methods or suitable alternative methods.
11.10 Residual hydrogen peroxide
For contact lens care products containing hydrogen peroxide, the residual
amount of hydrogen peroxide in the neutralized product shall be ≤ 30 mg/kg.
11.11 Cleaning efficiency
For contact lens care products with cleaning effects (such as protein removal,
etc.), manufacturers shall verify and document it.
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 shall ensure that the average bioburden
of the product within the validity period is less than 100 CFU/g (CFU/mL); it
shall be free of Staphylococcus aureus, Pseudomonas aeruginosa, E. coli and
other pathogenic bacteria. Bioburden can be checked in accordance with the
"Microbial Limit Inspection Method" in the Appendix of the Pharmacopoeia of
the People's Republic of China (2005), part 2; pathogenic bacteria can be
checked in accordance with the relevant methods in the Appendix of the
specifications (see 5.1 in YY0719.3) can be called contact lens disinfecting
products. To ensure the safety of the wearer, the label or instruction manuals
shall clearly specify all the steps required to properly care for the contact lens.
16.3 For contact lens care products that does not meet the class 1 of direct
sterilization test specifications, but meets the class 2 of direct sterilization test
specifications (see 5.2 in YY 0719.3) and simulated sterilization test standards
(see 5.3 in YY 0719.3), they shall be called contact lens disinfecting regimen.
To ensure the safety of the wearer, the label or instruction manuals shall clearly
specify all the steps required to properly care for the contact lens. A single-dose
component in the regimen shall not be called a contact lens disinfection solution
or contact lens disinfectant.
16.4 Labeling
The label on the primary packaging and/or other packaging of each contact lens
care product shall include at least the following information:
a) Name and address of the manufacturer;
b) Product name and/or model and specifications;
c) If applicable, indicate sterile status;
d) Batch number;
e) Validity period or effective date;
f) When applicable, the applicable contact lens type or the contraindicated
contact lens type;
g) When applicable, a warning that contact lens care products shall not be in
direct contact with eyes;
h) When applicable, "Do not use if the tamper-evident package is damaged";
i) Opening and discard date of multi-dose of contact lens care products;
j) A statement that unit dose contact lens care products are "only for single
use";
k) It shall clearly indicate all the steps required for the correct care of the
contact lens, or indicate that as shown in the instruction manual.
16.5 Instructions for use
The instructions for use shall include at least the following information:
a) Name and address of the manufacturer;