YY 0719.2-2009Ophthalmic optics - Contact lens care products - Part 2: Fundamental requirements (English PDF)

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.

12.1 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.

16.4 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; […]