ISO 11979-4 Ophthalmic Implants - Intraocular Lenses - Labeling and Information Test Standard

This part of ISO 11979 specifies labeling requirements for intraocular lenses (IOLs) and information to be provided on or on the packaging. This part of ISO 11979 attempts to harmonize recognized labeling requirements for IOLs worldwide, however, there may be additional national requirements.

For the purposes of this standard, the terms and definitions given in ISO 11979-1 apply.
The prospectus in brochure or similar form should be placed in the storage container so that it can be viewed without damaging the sterile package.

It will contain at least the following information;

• Manufacturer's name or trade name and address;
• Detailed description of the lens, including the material(s) used;
• Sterilization method;
• Storage and transport conditions (if applicable);
• Instructions for removal of the IOL from the primary vessel;
• Instructions for use;
• Indicator(s) of conditions under which the IOL may be used;
• Contraindication(s) for conditions in which I0L should not be used;
• Complication(s) that may occur;
• Warning not to implant the IOL if the sterile container is opened or damaged;
• Warning not to reuse the IOL;
• warning not to restar LOL;

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